**SUPPORTING STATEMENT**

**INFANT FORMULA RECALL REGULATIONS**

(21 CFR Part 107, Subpart E)

**OMB Control No. 0910-0188**

**A. JUSTIFICATION**

**1. Circumstances that Make Collection of Information Necessary**

> The Infant Formula Act of 1980 amended the Federal Food, Drug, and
> Cosmetic Act (the act) by adding section 412 (21 U.S.C. 350a) which
> provides for more stringent regulatory control over infant formula
> manufacturing and processing. 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) 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 (Attachment
> A). The Food and Drug Administrations (FDA) infant formula recall
> regulations (part 107, subpart E (21 CFR part 107, subpart E))
> implement these statutory provisions (Attachment B).
>
> In 1986, Congress amended the Infant Formula Act of 1980 to address
> concerns expressed by industry, the agency and consumers regarding the
> effectiveness and rapidity of the infant formula recall procedures.
> The agency has amended its recall regulations to reflect the statutory
> changes effected by the Infant Formula Act. The Final Rule was
> published January 27, 1989 (Attachment C).
>
> We are requesting approval from OMB on the following collections of
> information requirements:
>
> **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.
> **(Language Approval Only - See item 12b. for explanation.)**

**2. How, by Whom, and for What Purpose the Information is Used**

> Manufacturers must establish certain recordkeeping requirements,
> reporting procedures and operating protocols necessary to perform an
> effective recall of products that are in violation of the laws and
> regulations administered by FDA.
>
> The manufacturers keep records of product shipments and consignees. In
> the event of a recall, a manufacturer must collate this information
> and notify direct distributors and other buyers by the established
> process so that the orderly return of the recalled product to the
> manufacturer takes place. In some cases, depending on the severity of
> any health related hazard of the product under recall, the
> manufacturer must make additional announcements to the consuming
> public so that any customer having already purchased a hazardous
> product will be alerted as to the potential problem and encouraged to
> return the product.
>
> The information collected by the manufacturer is provided to FDA to
> enable FDA to conduct recall checks at various points in the
> product\'s distribution chain to determine the effectiveness of the
> recall. Obviously, the consequence of not having this information
> collection would be that products identified as adulterated or
> misbranded would not be quickly and efficiently pulled off the market.

**3. Use of Improved Information Technology**

> 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. Identification of Duplication and Similar Information Already
Available**

> 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. Small Businesses**

> 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 Office of Small
> Manufacturers Assistance and through the scientific and administrative
> staffs within the Agency.

**6. Consequences if Data were Collected 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**

> The reporting activity is more intense than that specified in 5 CFR
> 1320.5. Concern over the conduct of the infant formula recalls was the
> basis for Congressional action in amending the Act to require the
> reporting activity of 107.240 and 107.250 (21 CFR 107.240 and
> 107.250). From a public health perspective, this level of activity is
> required because of the risk to the health of the infant consumer and
> because these products are used as the sole source of sustenance for
> this highly vulnerable population group.
>
> For FDA to efficiently and effectively monitor the recall of all
> infant formulas and fulfill its recall oversight responsibilities
> under Section 412(d)(1)(A) of the act, the agency must be made aware
> at the earliest possible time that a recall is being conducted.
> Therefore, 21 CFR 107.240 requires that a firm promptly notify the
> agency by telephone at the time that the firm decides to initiate the
> recall. 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.
>
> In 1978, a major manufacturer of infant formulas reformulated two of
> his products by discontinuing the addition of salt. The reformulation
> resulted in products containing an inadequate amount of chloride, an
> essential nutrient. By mid-1979, hypochloremic metabolic alkalosis, a
> syndrome associated with chloride deficiency, had been diagnosed in a
> substantial number of infants. Most of the cases resulted from
> prolonged and exclusive use of the reformulated products. A recall was
> instituted for these defective products, however, the recall did not
> result in the prompt removal of all the chloride-deficient formulas
> from many retailers and wholesalers.
>
> After reviewing the matter, Congress acted to improve the protection
> of infants using formula products by amending the act to establish in
> Section 412(f)(1) (21 U.S.C. 350a(f)) that if a recall is begun by a
> manufacturer, the manufacturer shall, \"not later than the 14th day
> after the beginning of such recall and at least once every 14 days
> thereafter until the recall is terminated, report to the Secretary the
> actions taken to implement the recall.\" These sections of the act are
> the statutory bases of 21 CFR 107.250.

**8. Consultation Outside the Agency**

> On March 6, 2002 (67 FR 10219), FDA published a 60-day notice in the
> Federal Register soliciting public comment as required under the PRA
> of 1995 (Attachment D). FDA did not receive any comments regarding the
> information collection requirements contained in this submission.

**9. Payment or Gifts**

> No payment or gifts are offered to respondents for fulfilling their
> obligation to provide information.

**10. Confidentiality**

> FDA provides no assurance of confidentiality to firms that voluntarily
> decide to, or are required to, conduct recalls.

**11. Sensitive Questions**

> The information required to conduct a recall does not involve any
> question of a sensitive nature.

**12. Respondent Hour Burden and Annualized Burden Hour Costs
Estimates**

> The total estimated annual burden for this collection of information
> is 18,956 hours.
>
> a\. [Reporting]{.underline}.
>
> The agency estimates that there will be approximately three infant
> formula recalls a year. This estimate is based on the number of infant
> formula recalls occurring in 1999 (three), 2000 (two), and 2001
> (three).
>
> b\. [Recordkeeping]{.underline}.
>
> 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. 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.

The burden hours estimated for this collection of information is as
follows:

  --------------------------------------------------------------------------
  Estimated                                                         
  Annual                                                            
  Reporting                                                         
  Burden                                                            
  ----------- ------------- ---------------- ----------- ---------- --------
  21 CFR      No. of        Annual Frequency Total       Hours per  Total
  Section     Respondents   per Response     Annual      Response   Hours
                                             Responses              

  107.230     3             1                3           4,500      13,500

  107.240     3             1                3           1,482      4,446

  107.250     3             1                3           120        360

  107.260     1             1                1           650        650

  Total                                                             18,956
  --------------------------------------------------------------------------

> [Estimated Annualized Burden Hour Costs for Respondents.]{.underline}
>
> The total estimated annualized cost to the manufacturers for this
> collection is \$855,484. This is based on an hourly wage (including
> benefits) of \$45.13/hour for an estimated time of 18,956 hours or
> approximately \$855,484.

**13. Costs to Respondents**

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

**14. Cost to the Federal Government**

> The estimated cost to the federal government is approximately
> \$218,554. This is based on the salaries of five (5) FTE\'s at GS 13-4
> (\$72,851/year) who spend an estimated 0.3 man-years each or a total
> burden of 3,100 hours. (5 FTE x \$72,851/yr x 0.3 m-yr/FTE =
> \$109,277). To account for overhead, this cost is increased by 100
> percent, making the estimated cost to the federal government
> \$218,554.

**15. Change in Burden**

> The hour burden is unchanged.

**16. Publication of Collected Information**

There are no plans to publish the information collected under the
provisions of this regulation for statistical use.