0502 supporting statement for proposed rule 9 APR 2015

Registration of Food Facilities under the Public Health
Security and Bioterrorism Preparedness and Response Act of 2002

OMB Control No. 0910-0502
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. We are proposing to codify
the requirements of section 102 of FSMA that were self-implementing and effective upon
enactment of FSMA. In addition, we are proposing to implement other requirements of section
102 of FSMA to include mandatory electronic registration submissions beginning in 2016, and
amendments to the retail food establishment definition. The proposed rule also includes
additional reporting requirements in order to improve the utility of the food facility registration
database. FDA is therefore requesting OMB review and approval of the following revisions to
the information collection provisions approved under OMB Control No. 0910-0502 as provided
for under the FSMA amendments to section 415 of the FD&C Act, and as described and
contained in the proposed rule entitled, “Amendments to Registration of Food Facilities,” that
published April 9, 2015 (80 FR 19159).

Reporting; 21 CFR 1.230 - 1.233
Requires a facility to register with FDA and sets forth additional information that the registration
submission is required to contain, as well as requiring items of information that registrants were
formerly encouraged to submit and the method of submitting the registration.
Reporting; 21 CFR 1.234
Requires a facility to submit timely updates within 30 days of a change to any required item of
registration information.
Reporting; 21 CFR 1.245
Requires mandatory electronic registration submissions beginning in 2016, which would cause
some food facilities to submit a request for a waiver from that requirement.
Requires verification procedures for registration submissions made by individuals other than the
owner, operator, or agent in charge, as well as a verification procedure for U.S. Agents.
Reporting; 21 CFR 1.230 - 1.233
Form FDA 3537 and Form FDA 3537a
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. Form 3537 can no longer be submitted using CD-ROM
for multiple registration submissions and updates.
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. The proposed
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

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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
The term “Form FDA 3537” refers to both the paper version of the form and the electronic
submission system known as the Food Facility Registration Module, which is available at
http://www.access.fda.gov. Forms FDA 3537 and 3537a are available for download for
registration or by mail. FDA estimates that nearly ninety-nine percent (99%) of the respondents
will use electronic means to submit the required information. At the same time, if the rule is
finalized as proposed, it would mandate the electronic submission of food facility registrations,
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 that collects this information as a result of the mandatory
reporting requirements in Section 415 of the FD&C Act. FDA also requires registration of Low
Acid Canned Foods (LACF) and infant formulas. However, these two registration programs are
not a good substitute for the Food Facility Registration information collection for the following
reasons: (1) LACF and infant formula registration are on a per-formulation or process basis; (2)
there may be multiple registered products produced in a single facility or a single registered
process or formulation may be produced in multiple facilities; (3) not all items of information
required for Food Facility registration (especially relating to emergency contact) are required for
LACF or infant formula registration at this time; and (4) these two registration programs do not
cover all food types covered under Food Facility Registration.
Certain registration requirements also exist at the state and local level. However, such
registration requirements vary from jurisdiction to jurisdiction in terms of the information
required, facilities covered, and form of reporting. FDA 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. Finally, FDA is
required to assign each food facility a unique registration number under section 415(a)(4) of the
FD&C Act. FDA knows of no other registration systems that meet these requirements.
5. Impact on Small Businesses or Other Small Entities
FDA estimates that approximately ninety-nine percent (99%) of the respondents are small
businesses. The reporting requirements are those mandated by the Bioterrorism Act and FSMA
and there is no statutory exception for small businesses under these laws. The same information
is requested from large and small firms alike and is the minimal amount needed. However, FDA
aids small businesses in complying with its requirements through its Regional Small Business
Representatives and through the scientific and administrative staffs within the agency. FDA has
provided a Small Business Guide on its website at http://www.fda.gov/oc/industry/. In addition,
the FDA Industry Systems Help Desk can answer computer system and technical questions, as

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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
A facility that begins to manufacture/process, pack, or hold food for consumption in the U.S. on
or after December 12, 2003 is required to register before it begins such operations. Also, all
facilities that manufacture/process, pack or hold food for consumption in the U.S. are required to
submit registration renewals to FDA biennially, and occasional updates within 30 days instead of
60 days of a change in a facility’s required information, and cancellations when such facilities
cease operations. If the collection is not conducted or is conducted less frequently, domestic and
foreign facilities that manufacture, process, pack, or hold food for human or animal consumption
in the United States may not comply with section 415 of the FD&C Act. 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 in case of a known or potential threat to the food supply or other foodrelated emergency.
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
The proposed rule published in the Federal Register on April 9, 2015 (80 FR 19159).
9. Explanation of Any Payment or Gift to Respondents
This information collection does not provide for 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
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 under sections
552(a) and (b) (5 U.S.C. 552(a) and (b)), and by part 20 of the agency’s regulations (21 CFR part
20).
11. Justification for Sensitive Questions
This information collection does not involve questions that are of a personally sensitive nature.

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12. Estimates of Annualized Burden Hours and Costs
12 a. 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

All facility registrations
(1.230-1.233)

No. of
Respondents

172,274

No. of
Responses
per
Respondent

Total Annual
Responses

1

172,274

Average Burden per
Response

0.18 (11 mins)

Total
Hours

31,584

1

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

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 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 the proposed rule. We
estimate that the average burden per response would be increased by the new data elements in
the proposed 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
would require, on average, an additional minute for each new data element per response. The
four additional pieces of information that are currently optional are: 1) Preferred mailing address,
2) e-mail address for the owner opperator 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 facilitiy.
In addition, we estimate that entering a D-U-N-S® Number, would require, on average, an
additional minute per response. Thus, we estimate that these five proposed new data elements
will require a total of five additional minutes. We estimate that the submission of the FSMA
data elements and proposed new data elements would jointly increase the one-time burden from
those activities by a total of eleven minutes (0.18 hour). The estimated one-time burden for
currently-registered facilities is therefore 172,274 facilities x 0.18 hours = 31,584 hours.

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Activity/21 CFR
Section
New domestic facility
registrations (1.2301.233)

Table 2.-- Estimated Annual Reporting Burden1
No. of
No. of
Responses
Total Annual
Average Burden per
Respondents
per
Responses
Response
Respondent

Total

9,795

1

9,795

2.7

26,284

New foreign facility
registrations (1.2301.233)

13,697

1

13,697

8.7

118,993

Updates (1.234)
Cancellations (1.235)

68,518
6,390

1
1

68,518
6,390

1.5
1

105,632
6,390

Biennial renewals
97,883
1
97,883
0.38
36,706
(1.235)
Waiver requests
1,061
1
1,061
0.17
180
(1.245)
Third party registration
verification procedure
41,256
1
97,883
0.25
10,314
(proposed 1.232(a)(10))
U.S. Agent verification
procedure (proposed
57,070
1
57,070
0.5
28,535
1.231(a)(5) and (b)(7))
Total Hours
332,971
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 the proposed rule is 332,971 hours, a decrease of 135,146 hours. This decrease is due to
the recently reduced number of active registrations in the food facility registration database.
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.
We are proposing to make additional changes to the currently-approved reporting burden as well.
As discussed above, FDA obtained a 6-month emergency OMB approval of the selfimplementing FSMA reporting burdens, and subsequently obtained a 3-year approval of these
requirements. As described in the preliminary economic impact analysis, we estimate that
68,518 respondents will file updates, a decrease from the estimated number of 118,530
respondents reported in the 2013 request for extension, and we estimate that 97,883 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.
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 proposed rule would add an additional 11 minutes to that burden as a result of the
proposed 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
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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 reported in table 2,
rows 1 and 2.
The proposed rule would also shorten the time period for updates from 60 calendar days to 30
calendar days. The average burden per response for updates would increase from 1.2 hours to
1.54 hours (difference of 0.34 hours, or about 20 minutes), as reported in table 2 row 3.
This proposed rule would also establish an abbreviated renewal process, which modifies our
previous estimate that on average it would 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 would be able to take advantage of the abbreviated renewal process, while other
firms would take more time to prepare and submit the renewal, as discussed in the preliminary
economic impact analysis. We have not changed our estimate of the average burden per
response for cancellations because the proposed rule does not add new data elements for
cancellations.
If the rule is finalized as proposed, it would mandate the electronic submission of food facility
registrations, while also allowing respondents to submit a request for waiver of the requirement
to electronically submit their registration. As described in the preliminary economic impact
analysis, we estimate that, on average, 1,061 facilities will seek a waiver each year. We also
estimate that it would take a respondent ten minutes to prepare the proposed waiver request
submission and attach it to their paper Form FDA 3537 registration submission. Thus, the total
annual burden of submitting waiver requests is calculated to be 180 hours (1,061 x 0.17 hours),
as reported in table 2, row 6.
If the rule is finalized as proposed, it would 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. To verify third-party
registrations, FDA would send an e-mail to the owner, operator or agent in charge with a link
allowing the owner, operator, or agent in charge to either confirm or deny that he or she
authorized the registration submission on behalf of the facility. In connection with requiring his
verification process, the proposed rule would add 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 preliminary
economic impact analysis, we estimate that it would take an owner, operator, or agent in charge
fifteen minutes (0.25 hour) to participate in FDA’s verification procedure. This estimate
includes the time required to enter the e-mail address of the owner, operator, or agent in charge
who authorized the submission. We further estimate that 82,513 registrations would be affected
once every other year, or 41,257 annually. Thus, the total annual burden of these verifications is
estimated to be 10,314 hours (41,257 x 0.25 hour = 10,314 hours), as reported in table 2, row 7.

7

To verify the U.S. Agent, FDA would send an e-mail to the U.S. Agent at the e-mail address
provided by the registrant. The e-mail address would include a link that would connect the U.S.
Agent to FDA’s food facility registration module, allowing the U.S. Agent to either accept or
decline assignment with the facility. If the U.S. Agent accepts the assignment, FDA would also
e-mail the facility of the U.S. Agent’s acceptance. If, however, a U.S. Agent declines the
assignment, the issuance of the registration number could be delayed. We estimate that the
burden that will result from the verification procedure would be about 30 minutes (0.5 hours).
We also estimate that 114,139 registrations would be affected once every two years, or 57,070
facility registrations annually. Thus, the total annual burden of these verifications is estimated to
be 28,535 hours (57,070 x 0.5 hour = 28,535 hours), as reported in table 2, row 8.
Although FDA’s authority to suspend registration under section 415(b) of the FD&C Act became
effective on July 3, 2011, FDA is required by section 415(b) to promulgate regulations to
implement the suspension of registration provisions. Such regulations may more fully explain
components of the suspension of registration provisions. Registered facilities are subject to the
suspension of registration requirements in section 415(b) of the FD&C Act regardless of the
status of the regulations implementing section 415(b). FDA will provide a registrant subject to a
suspension order with an opportunity for an informal hearing. FDA will reinstate a registration if
it determines that adequate grounds do not exist to continue the suspension of the registration
(section 415(b)(3) of the FD&C Act). If FDA determines that a suspension of registration
remains necessary after providing opportunity for an informal hearing, FDA will require the
registrant to submit a corrective action plan to demonstrate how the registrant plans to correct the
conditions found by FDA (section 415(b)(3)(A) of the FD&C Act).
As noted, FDA expects to conduct a future rulemaking to implement the suspension of
registration provisions. During the rulemaking, FDA will estimate the information collection
burdens, if any. At this time, however, we conclude that the collections of information in section
415(b) of the FD&C Act 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 a civil action to
which the United States or any official or agency thereof is a party, or during the conduct of an
administrative action, investigation, or audit involving an agency against specific individuals or
entities. The regulation in 5 CFR 1320.4(c) provides 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 or the equivalent would
be opened with respect to a particular food facility as part of an investigation regarding
suspending the registration of such a food facility. Thus, we have not included the burden of the
FDA procedures associated with suspension of registration, including the registrant’s opportunity
to request an informal hearing related to the suspension of the registrant’s registration, and, if
FDA determines that a suspension of registration remains necessary, the requirement that a
registrant submit a corrective action plan to demonstrate how the registrant plans to correct the
conditions found by FDA.
12 b. Annualized Cost Burden Estimate
The annual hour cost burden to respondents is approximately $9,698,111 per year for the new
information collections required under FSMA. FDA estimates that the average hourly wage for
8

the employee preparing and submitting the request for certification would be equivalent to a GS12/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 overall estimated cost incurred by the
respondents for the new information collections required under FSMA is $ 9,698,111 (135,147
burden hours x $71.76/hr = $9,698,111).
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 agency has revised its estimated annual burden for this information collection by an increase
of 86,053 annual responses and by a decrease of 105,710 annual hours. This revised estimate is
broken down as follows:
IC #
1
2
3
4 (No change)
5
6 (New IC)
7 (New IC)
8 (New IC)
Total

Annual Responses Annual Hours
-1285
-3469
-6203
-57946
-50012
-39459
0
0
-127047
-75269
172274
31584
41256
10314
57070
28535
86053
-105710

16. Plans for Tabulation and Publication and Project Time Schedule
The information from this collection will not be published or used for general statistical
purposes.

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17. Reason(s) Display of OMB Expiration Date is Inappropriate
There are no reasons why display of the expiration date for OMB approval of the information
collection would be inappropriate.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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