SUPPORTING STATEMENT
1. Circumstances
Making the Collection of Information Necessary
Section
412(e) of the Federal Food, Drug, and Cosmetic Act (the act) (21
U.S.C. 350a(e)) provides that if the manufacturer of an infant
formula has knowledge that reasonably supports the conclusion that an
infant formula processed by that manufacturer has left its control
and may not provide the nutrients required in section 412(i) of the
act or is otherwise adulterated or misbranded, the manufacturer must
promptly notify the Secretary of Health and Human Services (the
Secretary). If the Secretary determines that the infant formula
presents a risk to human health, the manufacturer must immediately
take all actions necessary to recall shipments of such infant formula
from all wholesale and retail establishments, consistent with recall
regulations and guidelines issued by the Secretary. Section
412(f)(2) of the act states that the Secretary shall by regulation
prescribe the scope and extent of recalls of infant formula necessary
and appropriate for the degree of risk to human health presented by
the formula subject to recall. FDA's infant formula recall
regulations in part 107 (21 CFR part 107) implement these statutory
provisions.
Section 107.230 requires each recalling firm to conduct an infant formula recall with the following elements: (1) Evaluate the hazard to human health, (2) devise a written recall strategy, (3) promptly notify each affected direct account (customer) about the recall, and (4) furnish the appropriate FDA district office with copies of these documents. If the recalled formula presents a risk to human health, the recalling firm must also request that each establishment that sells the recalled formula post (at point of purchase) a notice of the recall and provide FDA with a copy of the notice. Section 107.240 requires the recalling firm to conduct an infant formula recall with the following elements: (1) Notify the appropriate FDA district office of the recall by telephone within 24 hours, (2) submit a written report to that office within 14 days, and (3) submit a written status report at least every 14 days until the recall is terminated. Before terminating a recall, the recalling firm is required to submit a recommendation for termination of the recall to the appropriate FDA district office and wait for written FDA concurrence (§ 107.250). Where the recall strategy or implementation is determined to be deficient, FDA may require the firm to change the extent of the recall, carry out additional effectiveness checks, and issue additional notifications ( § 107.260). In addition, to facilitate location of the product being recalled, the recalling firm is required to maintain distribution records for at least 1 year after the expiration of the shelf life of the infant formula ( § 107.280).
We request OMB approval for the following information collection requirements contained in part 107:
21 CFR 107.230 – Reporting
Requires each recalling firm to evaluate the hazard to human health, devise a written recall
strategy, promptly notify each affected direct account (customer) about the recall, and furnish the appropriate FDA district office with copies of these documents.
If the recalled formula presents a risk to human health, the recalling firm must also request that each establishment that sells the recalled formula post (at point of purchase) a notice of the recall and provide FDA with a copy of the notice.
21 CFR 107.240 - Reporting
Requires the recalling firm to notify the appropriate FDA district office of the recall by telephone within 24 hours, to submit a written report to that office within 14 days, and to submit a written status report at least every 14 days until the recall is terminated.
21 CFR 107.250 - Reporting
Before terminating a recall, the recalling firm is required to submit a recommendation for termination of the recall to the appropriate FDA district office and wait for written FDA concurrence.
21 CFR 107.260 - Disclosure - Notification
Where the recall strategy or implementation is determined to be deficient, FDA may require the firm to change the extent of the recall, carry out additional effectiveness checks, and issue additional notifications.
21 CFR 107.280 - Recordkeeping
Requires the recalling firm to maintain distribution records for at least 1 year after the expiration of the shelf life of the infant formula, to facilitate location of the product being recalled.
2. Purpose
and Use of the Information Collection
The
reporting and recordkeeping requirements described previously are
designed to enable FDA to monitor the effectiveness of infant
formula recalls in order to protect babies from infant formula that
may be unsafe because of contamination or nutritional inadequacy or
otherwise adulterated or misbranded. FDA uses the information
collected under these regulations to help ensure that such products
are quickly and efficiently removed from the market.
3. Use
of Improved Information Technology and Burden Reduction
FDA
has emphasized to manufacturers the importance of coding each lot of
formula produced and retaining the shipping and distribution records
for each lot. The coding identifies the location and date of
manufacture, and what line within the plant that produced the
problem product. When it becomes necessary to recall a product,
this information allows the manufacturer to locate the exact point
in the manufacturing process or the distribution chain where the
problem occurred. This automated system handles the recordkeeping
routinely, allows for the orderly return of the problem product to
the manufacturer, and results in significant savings in time and
money in the event a recall is necessary.
4. Efforts
to Identify Duplication and Use of Similar Information
FDA
is the only Federal agency that collects this information. No
duplication can occur as each manufacturer is responsible for his
own shipping routes and records. Each recall of an infant formula
product is unique. The information needed to accomplish the recall
is the exact shipping and distribution pattern for a specific lot or
group of lots of a particular product. The information is not
available from any other source.
5. Impact on Small
Businesses or Other Small Entities
The
production of processed foods requires that producers take on a very
high degree of responsibility, especially for infant formula
products. In the event of a recall, the safety of infants is
involved and the first priority is the removal of hazardous foods
(infant formulas) from channels of commerce. FDA will provide
assistance to any firm in achieving this goal. Also, FDA aids small
businesses in dealing with the requirements through the agency’s
Regional Small Business Representatives and through the scientific
and administrative staffs within the Agency.
6. Consequences
of Collecting the Information Less Frequently
A
recall is the result of a realization that an adulterated or
misbranded infant formula which presents a risk to human health is
present in the marketplace. The frequency of such recalls cannot be
predicted. If manufacturers were more reluctant to conduct recalls,
FDA, in order to protect the public health, would be required to
initiate seizure action or another type of regulatory action to
remove these products from channels of commerce.
7. Special
Circumstances
Relating to the
Guidelines of 5 CFR 1320.5
Respondents
are required to report more often than quarterly and to prepare a
written response in less than 30 days. In the event of a recall, §
107.240 requires the recalling firm to notify the appropriate FDA
district office of the recall by telephone within 24 hours, to
submit a written report to that office within 14 days, and to submit
a written status report at least every 14 days until the recall is
terminated. This early notification allows the agency the
opportunity to evaluate and comment on the recalling firm's
strategy. In addition, such notification eliminates needless
regulatory actions which the agency might otherwise take against
violative products in order to protect the public health. For
example, FDA would not normally initiate a seizure action against a
violative infant formula if it knew that the shipment was being
recalled by the responsible firm. Frequent reporting is required to
protect the health of the infant consumer because these products are
used as the sole source of sustenance for this highly vulnerable
population group.
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 March 26, 2008 (73 FR
16018). No comments were received.
FDA estimates the burden of this collection of information as follows:
21 CFR Section |
No. of Respondents |
Annual Frequency per Response |
Total Annual Responses |
Hours per Response |
Total Hours |
107.230 |
2 |
1 |
2 |
4,500 |
9,000 |
107.240 |
2 |
1 |
2 |
1,482 |
2,964 |
107.250 |
2 |
1 |
2 |
120 |
240 |
107.260 |
1 |
1 |
1 |
650 |
650 |
Total |
|
|
|
|
12,854 |
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The reporting burden estimate is based on agency records, which show that there are five manufacturers of infant formula and that there have been, on average, two infant formula recalls per year for the past 3 years. Thus, FDA estimates that two respondents will conduct recalls annually pursuant to §§ 107.230, 107.240, and 107.250. The estimated number of respondents for § 107.260 is minimal because this section is seldom used by FDA; therefore, the agency estimates that there will be one or fewer respondents annually for § 107.260. The estimated number of hours per response is an average based on the agency's experience and information from firms that have conducted recalls.
Under 5 CFR 1320.3(b)(2), the time, effort, and financial resources necessary to comply with a collection of information are excluded from the burden estimate if the reporting, recordkeeping, or disclosure activities needed to comply are usual and customary because they would occur in the normal course of activities. No burden has been estimated for the recordkeeping requirement in § 107.280 because these records are maintained as a usual and customary part of normal business activities. Manufacturers keep infant formula distribution records for the prescribed period as a matter of routine business practice.
Estimated Annualized Cost for the Burden Hours:
FDA estimates the annualized cost to respondents for the hour burden associated with the requirements of this regulation to be approximately $664,166. This estimate is based upon an industry employee making a salary equivalent to a GS-14 step 4 level in the locality pay area of Washington-Baltimore at $51.67/hour in 2008 ($51.67/hr x 12,854 hrs = $664,166.18).
13. Estimates
of Other Total Annual Cost Burden to Respondents and Record
Keepers
There
are no capital costs or operating and maintenance costs associated
with this collection.
14. Annualized
Cost to Federal
Government
The
estimated cost to the Federal Government to respond to the current
level of infant formula recalls is approximately $273,777. This is
based on the salaries of five (5) FTE's at an average salary of
GS-13, Step 4, in the Washington-Baltimore Locality Pay Area for
2008 ($91,259/year) who each spend an estimated 3/10 of their time
on infant formula recalls (5 FTE x $91,259/yr x 0.3 = $136,888.5).
To account for overhead, this cost is increased by 100 percent,
making the estimated cost to the Federal Government $273,777.
15. Explanation
for Program Changes or Adjustments
The
estimate of the number of burden hours is unchanged. At this time
the agency does not have any reason to expect the number of recalls
to change over the next three years.
16. Plans for Tabulation and Publication and Project Time Schedule
Once
a recall of infant formula has been determined to be necessary, the
firm is required to notify each of its affected accounts of the
recall, and instruct each consignee to report whether or not they
are in possession of the recalled infant formula and include a means
to do so. If necessary a public warning is to be given.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
We are not seeking approval to not display the expiration date for OMB approval of this information collection.
18. Exceptions
to Certification for Paperwork Reduction Act Submissions
There
are no exceptions to the certification statement.
| File Type | application/msword |
| File Title | Supporting Statement for |
| Author | Joanna Capezzuto |
| Last Modified By | Jonna Capezzuto |
| File Modified | 2008-07-16 |
| File Created | 2008-07-16 |