Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infant Formula Recall Regulations

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

DATES:

Fax written comments on the collection of information by September 19, 2011.

ADDRESSES:

To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910-0188. Also include the FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Denver Presley, Jr., Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-3793.

SUPPLEMENTARY INFORMATION:

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Infant Formula Recall Regulations—21 CFR 107.230, 107.240, 107.250, 107.260, and 107.280—(OMB Control Number 0910-0188)—Extension

Section 412(e) of the Federal Food, Drug, and Cosmetic Act (the FD&C 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 FD&C 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 FD&C 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).

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.

In the Federal Register of June 7, 2011 (76 FR 32976), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

FDA has added a new table 2 to this document to comply with the new requirement to report third-party disclosure burden hours in a separate table. The third-party disclosure burden hours were previously reported in the 60-day notice under the reporting burden table (table 1). In compliance with the new requirement, we have broken out the third-party disclosure burden hours in a new third-party disclosure burden table (table 2). FDA has moved 50 hours per recall from line 1 of table 1 to line 1 of table 2, and 25 hours per recall from line 4 of table 1 to line 2 of table 2. This is being done to show the third-party disclosure burden previously disclosed in table 1. The total estimated burden of this collection remains unchanged at 12,864 hours.

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

The reporting and third-party disclosure burden estimates are 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. Based on this information, we estimate that there will be, on average, approximately two infant formula recalls per year over the next 3 years.

Thus, FDA estimates that two respondents will conduct recalls annually under §§ 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 reporting burden hours per response is an average based on the Agency's experience and information from firms that have conducted recalls. We estimate that two respondents will conduct infant formula recalls under § 107.230 and that it will take a respondent 4,450 hours to comply with the requirements of that section, for a total of 8,900 hours. In the 60-day notice, we estimated that it will take a respondent 4,500 hours per recall to comply with § 107.230 for a total of 9,000 hours. As noted, we have added a new table 2 to report third-party disclosure burden hours. The new lower figure of 4,450 hours per recall reflects that 50 hours are being reported in new table 2. We estimate that two respondents will conduct infant formula recalls under § 107.240 and that it will take a respondent 1,482 hours to comply with the requirements of that section, for a total of 2,964 hours. We estimate that two respondents will submit recommendations for termination of infant formula recalls under § 107.250 and that it will take a respondent 120 hours to comply with the requirements of that section, for a total of 240 hours. Finally, we estimate that one respondent will need to carry out additional effectiveness checks and issue additional notifications under § 107.260, for a total of 625 hours. In the 60-day notice, we estimated that it will take a respondent 650 hours per recall to comply with § 107.260 for a total of 650 hours. As noted, we have added a new table 2 to report third-party disclosure burden hours. The new lower figure of 625 hours per recall reflects that 25 hours are being reported in new table 2.

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.

New table 2 reports the Agency's third-party disclosure burden estimates for §§ 107.230 and 107.260. The estimated burden hours per disclosure is an average based on the Agency's experience. The third-party disclosure burden in § 107.230 is the requirement to promptly notify each affected direct-account (customer) about the recall and if the recalled formula presents a risk to human health, the requirement that the recalling firm must also request that each establishment that sells the recalled formula post (at the point of purchase) a notice of the recall. We estimate that two respondents will conduct infant formula recalls under § 107.230 and that it will take a respondent 50 hours to comply with the third-party disclosure requirements of that section, for a total of 100 hours. The third-party disclosure burden in § 107.260 is the requirement to issue additional notifications where the recall strategy or implementation is determined to be deficient. We estimate that one respondent will issue additional notifications under § 107.260 and that it will take a respondent 25 hours to comply with the third-party disclosure requirements of that section, for a total of 25 hours.