FDA Recall Regulations

OMB No. 0910-0249

# Supporting Statement

A. Justification

1\. **Circumstances Necessitating Information Collection**

Section 701 of the Federal Food, Drug, and Cosmetic Act (Attachment A),
and 21 CFR Part 7, Subpart C (Attachment B), 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; and
biological products intended for human use).

The Food and Drug Administration (FDA) is requesting approval from the
Office of Management and Budget (OMB) for the information collection
requirements contained in:

**21 CFR 7.42 - Recall Strategy - Reporting**

Requests firms to develop a recall strategy including provisions for
public warnings and effectiveness checks.

**21 CFR 7.46 - Firm Initiated Recall - Reporting**

Requests firms that voluntarily remove or correct foods and drugs
(animal or human), cosmetics, medical devices and biologicals 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 - Reporting**

Requires 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 access 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.

**2. How, By Whom, Purpose of 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 the 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.

**3. Consideration Given to Information Technology**

The FDA is continuously seeking ways to reduce the reporting burden
through advances in information technology.

**4. Identification of Information**

The recall regulation imposes a burden that is not duplicative of any
comparable requirement imposed by government or industry, to FDA's
knowledge. Similar information is not available to FDA.

**5. Small Businesses**

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. Less Frequent Information Collection**

The impact of not collecting the information or requiring the reports
and notification in those instances where FDA has determined that recall
should be conducted could seriously compromise the public health.

**7. Special Information Collection Circumstances**

The information collection requirements in this request are inconsistent
with that outlined in 5 CFR 1320.6 The reports are obtained more often
than quarterly. Section 21 CFR 7.53(a), requests the recalling firm to
submit status reports to the FDA, determined by the urgency of the
recall, between 2 and 4 week intervals.

**8. Outside Consultation**

In accordance with 5 CFR 1320.8(d), on May 1, 2001 (Volume 66, No. 84,
page 21767) a 60-day notice for public comment (Attachment C) was
published in the Federal Register. One comment was received from the
public.

We agree with the comment that the agency is slow in providing the
recall classification letter to recalling firms and are taking steps to
streamline the classification process which, in turn, will improve the
timeliness of the classification letter. However, we believe that
recalling firms are usually aware of the significance of the defect in a
recalled product and know the likely FDA classification. This may be
based on the firm's own health hazard evaluation, by precedent recalls
and information published on FDA's websites, and/or by verbal
communication with FDA district office recall coordinators. The latter
is especially true regarding the classification of serious to
potentially life-threatening hazard to health recall actions (Class I).
In such situations, the delivery of a classification letter usually
follows extensive communications between recalling firms and FDA in
which classification, recall strategy and press releases are immediately
discussed.

We have accepted the commenter's estimate of the time expended to
conduct recalls and have used those figures, coupled with revised recall
numbers, to develop what we believe to be a more realistic estimate of
the time expended by FDA regulated industry to develop and report recall
information requested by FDA.

The FDA agrees with the comment to have a process whereby reports and
any other necessary information can be submitted by email. In many
cases, this has become routine for some firms and FDA district offices.
Certainly there is no reason not to use email or facsimile
communications in most recall situations; however, FDA would maintain
the prerogative for investigational visits and other in-person
communications where the agency considers it appropriate. In fact, FDA
is currently working toward providing \"industry guidance\" on-line
which will provide a format for industry responses to recall situations.

At the present time, the names and telephone numbers of FDA\'s district
office recall coordinators may be found at the following website:
http://www.fda.gov/ora/inspect_ref/iom/iomoradir_monitors.html#RECALL.
Unfortunately, this provides information from FDA\'s latest published
location directory and is not always current. We will see that this list
is updated if it is possible to do so. Additionally, changes to the FDA
Website\'s recall information and reporting systems which are currently
under development, will maintain an easy to locate, user friendly recall
section that will include a current listing of all district coordinators
that will include names, telephone and facsimile numbers, mail and email
addresses.

At this time, we will refer to the Center for Food Safety and Nutrition
your suggestion to allow Processing Authorities to authorize
reconditioning/destruction of thermally processed low acid and acidified
foods in hermetically sealed containers and for the recalling firm to
then submit a summary of the disposition action to FDA.

**9. Payment or Gift**

No payment or gift was provided.

**10. Confidentiality Provisions**

No sensitive information is sought under this guideline. 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.** **Privacy**

Questions of a sensitive nature are not applicable to this information
collection.

**12. Burden of Information Collection**

As a result of the comment received, the following is a revised summary
of the estimated annual burden hours for manufacturers, processors, and
distributors to comply with the voluntary 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 on average
the burden of collection for recall information to be 157,675

Estimated Annual Reporting Burden

+-------------+------------+----------+----------+----------+---------+
| 21 CFR      | No. of     | Annual   | Total    | Hours    | Burden  |
|             | R          | F        | Annual   | per      | Hours   |
|             | espondents | requency | R        | R        |         |
|             |            | per      | esponses | esponses | (       |
|             |            | Response |          |          | rounded |
|             |            |          |          |          | to      |
|             |            |          |          |          | nearest |
|             |            |          |          |          | one     |
+-------------+------------+----------+----------+----------+---------+
| 7.42        | 1855       | 1        | 1855     | 15       | 27,825  |
+-------------+------------+----------+----------+----------+---------+
| 7.46 & 7.49 | 1855       | 1        | 1855     | 20       | 37,100  |
+-------------+------------+----------+----------+----------+---------+
| 7.53        | 1855       | 4        | 7420     | 10       | 74,200  |
+-------------+------------+----------+----------+----------+---------+
| 7.55(b)     | 1855       | 1        | 1855     | 10       | 18,550  |
+-------------+------------+----------+----------+----------+---------+
| Total       |            |          |          |          | 157,675 |
+-------------+------------+----------+----------+----------+---------+

**13. Cost to Respondents**

The FDA has no information which would allow it to make any meaningful
estimate of the cost to FDA regulated Industry to conduct recalls.
Variables in the type of products, the quantity and level of
distribution and the various circumstances of recall notifications could
cause a recall to vary in cost from less that \$1,000.00 to more than
\$1,000,000.00

**14. Costs to Federal Government**

During FY 2000, FDA classified 1,855 industry actions as recalls. Each
of the 1,855 situations underwent a review process to determine if it
met the recall definition, what hazard to health existed, to what level
the recall should extend, what classification was appropriate, and the
number of FDA audit checks necessary to assure consumer protection. The
total costs for reviewing, classifying, auditing and monitoring the
1,855 actions in FY 2000 was approximately \$5,249,680.

The government's cost decreased from \$7,808,000 in previous years to
\$5,249,680 due to the decrease in the number of audit checks
accomplished by investigators.

The 1,855 recalls, in FY 2000, resulted in approximately 32,472 hours
spent making audit checks, etc. The projected investigator man years
(MY) is 940 resulting in a total of 34.5 operational FTEs. There are 1.8
support FTEs for each operational FTE for a total of 62.2 supported FTEs
and the current annual salary of \$84,000 per FTE or (32,472 hours + 940
(MY) = 34.5 operational FTEs x 1.8 support FTEs = 62.2 supported FTEs x
\$84,4000/FTE =\$5,249,680).

**15. Reason for Change**

The burden for this submission has increased from 74,985 hours to
157,685 hours annually due to an increase in the number of recalls, a
revised estimate of the number of status reports submitted per recall,
and an industry response to the federal register announcement requesting
review of FDA estimated figures.

**16. Statistical Reporting**

The reporting requirements contained in this proposal are not
statistical in nature and the records are not published for statistical
use.

**17. Display of OMB Approval Date**

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 not exceptions to "Certification for Paperwork Reduction Act
Submissions" for this collection of information.