0249 ss final 4-6-2018

FDA Recall Regulations
OMB Control Number 0910-0249
SUPPORTING STATEMENT
Terms of Clearance: None.
A. Justification
1. Circumstances Making the Collection of Information Necessary
Section 701 of the Federal Food, Drug, and Cosmetic Act, and 21 CFR Part 7, Subpart C, set
forth the recall regulations (guidelines) and provide guidance to manufacturers on recall
responsibilities. The guidelines apply to all regulated products (i.e., food, including animal
feed; drugs, including animal drugs; medical devices, including in vitro diagnostic products;
cosmetics; biological products intended for human use; and tobacco).
The Food and Drug Administration (FDA) is requesting approval from the Office of
Management and Budget for the information collection requirements contained in:
21 CFR 7.46 - Firm Initiated Recall – Reporting
Requests firms that voluntarily remove or correct foods and drugs (animal or human),
cosmetics, medical devices, biologics, and tobacco to immediately notify the appropriate
FDA district office of such actions. The firm is to provide complete details of the recall
reason, risk evaluation, quantity produced, distribution information, firms’ recall strategy and
a contact official.
21 CFR 7.49 - Recall Communications – Third Party Disclosure
Requests firms to notify their direct accounts of the recall and to provide recipients with a
ready means of reporting to the recalling firm.
21 CFR 7.53 - Recall Status Reports - Reporting
Requests that recalling firms provide periodic status reports so the FDA can assess the
progress of the recall.
21 CFR 7.55(b) - Termination of a Recall - Reporting
Provides an opportunity for a firm to request in writing that FDA terminate the recall.
21 CFR 7.59 – General Industry Guidance – Reporting
Prepare and maintain a current written contingency plan for use in initiating and effecting a
recall in accordance with 7.40 through 7.49, 7.53, and 7.55.

21 CFR 7.59 – General Industry Guidance – Recordkeeping
Maintain product distribution records as are necessary to facilitate location of products that
are being recalled.
2. Purpose and Use of the Information Collection
The agency recognizes that situations may arise involving health risks presented by unsafe
products. The recall provisions of 21 CFR Part 7, Subpart C provide the information
necessary for FDA to monitor recalls and assess the adequacy of a firm’s efforts in a recall.
It also permits FDA to evaluate whether a recall has been completed in a manner which
assures that unreasonable risk of substantial harm to the public health has been eliminated
and that violative products have been corrected or removed from the market.
3. Use of Improved Information Technology and Burden Reduction
FDA is continuously seeking ways to reduce the reporting burden through advances in
information technology. Firms have the option, and are encouraged, to provide required
information for recalls via email to the Recall Coordinators at FDA. It is estimated that
approximately 95% of recall submissions will be provided electronically via email.
4. Efforts to Identify Duplication and Use of Similar Information
The recall regulation imposes a burden that is not duplicative in its entirety of any
comparable requirement imposed by government or industry, to FDA’s knowledge. Some
similar information is available to FDA, for example in the mandatory reporting requirement
in 21 CFR Part 806 for reports of corrections and removals of medical devices and Section
417 of the Act for reportable food registry. However, the recall regulation requests
additional information from recalling firms such as status reports and requests for recall
terminations.
5. Impact on Small Businesses or Other Small Entities
The requirements will not fall disproportionately on small business. It is not possible to
provide an exemption for small business or to reduce the requirements for small business
without seriously compromising the public health. However, FDA does assist small business
through the Office of Small Manufacturers Assistance.
6. Consequences of Collecting the Information Less Frequently
Most of the information collected for recalls is a one time collection, with the exception of
recall status reports. 21 CFR 7.53 states that the recalling firm is requested to submit
periodic recall status reports so that the agency may assess the progress of the recall. The
frequency of such reports will be determined by the relative urgency of the recall and will be
specified by FDA in each recall case; generally the reporting interval will be between two
and four weeks.

The impact of not collecting the information or requesting the reports and notification in
those instances where FDA has determined that recall should be conducted could seriously
compromise the public health.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances for 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), on November 17, 2017, (82 FR 54359) FDA published
in the Federal Register a 60-day notice soliciting public comment. FDA received one
comment that did not suggest any changes to the information collection burden estimates.
9. Explanation of Any Payment or Gift to Respondents
No payment or gift was provided.
10. Assurance of Confidentiality Provided to Respondents
No sensitive information is sought under this information collection. Some confidential
commercial information may be reported to FDA but FDA’s public information regulations
(21 CFR Part 20) will govern the release of data.
11. Justification for Sensitive Questions
Questions of a sensitive nature are not applicable to this information collection.
12. Estimates of Annualized Burden Hours and Costs
12 a. Annualized Hour Burden Estimate
A search of the FDA database was performed to determine the number of recalls that took
place during fiscal years 2014 to 2016. The resulting number of total recalls and
terminations (8,560) from this database search were then averaged over the three years, and
the resulting per year average of recalls and terminations (2,853) are used in estimating the
current annual reporting and third party disclosure burden in this document.
The following is a summary of the estimated annual burden hours for recalling firms
(manufacturers, processors, and distributors) to comply with the reporting requirements of
FDA’s recall regulations recognizing that there may be a vast difference in the information
collection and reporting time involved in different recalls of FDA’s regulated products

FDA estimates the burden of this collection of information as follows:

21 CFR Section

Table 1.--Estimated Annual Reporting Burden1
Number of
Number of
Total
Respondent Responses per
Annual
s
Respondent
Responses
2,853
1
2,853

Firm initiated recall
(§ 7.46) and recall
communications (§ 7.49)
Recall status reports (§
7.53)
Termination of a recall
(§ 7.55(b))
General industry
guidance
(§ 7.59)
Total

Average
Burden per
Response
25

Total
Hours
71,325

2,853

13

37,089

10

2,853

1

2,853

10

370,89
0
28,530

2,853

1

2,853

15

42,795

513,54
0

Table 2--Estimated Annual Third-Party Disclosure Burden1
21 CFR Section
No. of
No. of
Total
Average
Total
Respondents Disclosures per
Annual
Burden per
Hours
Respondent
Disclosures
Disclosure
Recall
2,853
518
1,477,854
2.88 70,937
communications
minutes
(§ 7.49)
1
There are no capital costs or operating and maintenance costs associated with this information
collections.
FDA estimates the recordkeeping found at 21 CFR 7.59 to be zero as this recordkeeping is usual
and customary to these respondents.
12b. Annualized Cost Burden Estimate
FDA regulates many different types of products including, but not limited to, medical
products, food and feed, cosmetics, and tobacco products. Further, FDA notes that not all
recall events reported to the Agency are similar in nature and may entail different
information and volume of information on a case-by-case basis. Therefore, the FDA has no
information which would allow it to make any meaningful estimate of the cost to FDA
regulated industry to conduct recalls.
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 information
collection.

14. Annualized Cost to the Federal Government
There is one program support FTE for each operational FTE for a total of 102 FTEs (51
operational FTEs + 51 program support FTEs = 102 total FTEs). Every year FDA calculates
the full-loaded cost of a FTE. This cost includes salary, benefits, travel, training, IT support,
overhead, rent and supplies. In FY 2018 the fully-loaded FTE cost was $267,783 per FTE,
resulting in a total anticipated annualized cost to FDA of $27,313,886 to fund the 102 FTEs
in this program.
15. Explanation for Program Changes or Adjustments
The adjustment in burden is due to the decreased number of respondents from 3,801 to 2,853
(-948). When applied to each IC the decrease in the number of respondents affects the annual
number of responses, decreasing it by 224,958. In addition, FDA discovered that 21 CFR
7.59 (general industry guidance) contained information collection that was not previously
approved and, therefore, added it to this ICR for extension of OMB approval. With the
addition of this IC 42,795 hours were added to the total estimated number of burden hours
requested. Despite this addition, the decrease in the number of respondents reduced the total
estimated hourly burden by 137,409 hours. (104,229 Program Change Due to Agency
Discretion + 1,896 Change Due to Adjustment in Agency Estimate = 137,409.)
16. Plans for Tabulation and Publication and Project Time Schedule
The reporting requirements contained in this proposal will not be published, tabulated or
manipulated
17. Reason(s) Display of OMB Expiration Date is Inappropriate
We are not seeking approval to exempt display of the OMB approval date on any documents
that are associated with this information collection.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.