E7-5470. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infant Formula Requirements

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 April 25, 2007.

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: [phone].

FOR FURTHER INFORMATION CONTACT:

Jonna Capezzuto, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659.

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 Requirements (OMB Control Number 0910-0256)—Extension

Statutory requirements for infant formula under the Federal Food, Drug, and Cosmetic Act (the act) are intended to protect the health of infants and include a number of reporting and recordkeeping requirements. Among other things, section 412 of the act (21 U.S.C. 350a) requires manufacturers of infant formula to establish and adhere to quality control procedures, notify FDA when a batch of infant formula that has left the manufacturers' control may be adulterated or misbranded, and keep records of distribution. FDA has issued regulations to implement the act's requirements for infant formula in 21 CFR part 106 and part 107 (21 CFR parts 106 and 107). FDA also regulates the labeling of infant formula under the authority of section 403 of the act (21 U.S.C. 343). Under the labeling regulations for infant formula in part 107, the label of an infant formula must include nutrient information and directions for use. The purpose of these labeling requirements is to ensure that consumers have the information they need to prepare and use infant formula appropriately. In a notice of proposed rulemaking published in the Federal Register of July 9, 1996 (61 FR 36154) (the 1996 proposed rule), FDA proposed changes in the infant formula regulations, including some of those listed in tables 1 and 2 of this document. The 1996 proposed rule included revised burden estimates for the proposed changes and solicited public comment. In the interim, however, FDA is seeking an extension of OMB approval for the current regulations so that it can continue to collect information while the proposal is pending.

In the Federal Register of January 12, 2007 (72 FR 1539), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. The notice incorrectly reported the “Hours per Record” and the “Total Hours” for 21 CFR 106.100 and 107.50(c)(3) in Table 2. Table 2 of this document contains the correct burden estimate.

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

Table 1.—Estimated Annual Reporting Burden¹

Federal Food, Drug, and Cosmetic Act or 21 CFR Section	No. of Respondents	Annual Frequency per Response	Total Annual Responses2	Hours per Response	Total Hours
Section 412(d) of the act	5	13	65	10	650
106.120(b)	1	1	1	4	4
107.10(a) and 107.20	5	13	65	8	520
107.50(b)(3) and (b)(4)	3	2	6	4	24
107.50(e)(2)	1	1	1	4	4
Total					1,202
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 Manufacturers may submit infant formula notifications in electronic format.

Table 2.—Estimated Annual Recordkeeping Burden¹

21 CFR Section	No. of Recordkeepers	Annual Frequency per Recordkeeping	Total Annual Records2	Hours per Record	Total Hours
106.100	5	10	50	400	20,000
107.50 (c)(3)	3	10	30	300	9,000
Total					29,000
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: March 20, 2007.

Jeffrey Shuren,

Assistant Commissioner for Policy.