2024-28230. Notifying the Food and Drug Administration of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula; Draft Guidance for Industry; Availability; Agency Information Collection Activities; ...

Table 1—Estimated Annual Reporting Burden ¹

Activity; section 424(a)(1) of the FD&C Act	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
Notification of a permanent discontinuance or an interruption of the manufacture of a critical food	8	1	8	2	16
1  There are no capital costs or operating and maintenance costs associated with this collection of information.

The estimates in table 1 are based on our experience with similar notification programs. We estimate that each year 5 manufacturers of infant formula will submit notifications in compliance with section 424(a)(1) of the FD&C Act and following recommendations found in the draft guidance. We also estimate that each year 3 manufacturers of medical foods will submit notifications in compliance with section 424(a)(1) of the FD&C Act, for a total of 8 manufacturers of a critical food. We estimate that each manufacturer will submit 1 notification for 8 total annual notifications (8 manufacturers × 1 notification). Each submission will take an estimated 2 hours to complete for an annual reporting burden of 16 hours (8 notifications × 2 hours).

Table 2—Estimated Annual Recordkeeping Burden ¹

Activity; section 424(b) of the FD&C Act	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
Risk management plan	11	1	11	60	660
1  There are no capital costs or operating and maintenance costs associated with this collection of information.