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Notice

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

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.

 

Table of Contents Back to Top

Tables Back to Top

DATES: Back to Top

Fax written comments on the collection of information by September 9, 2010.

ADDRESSES: Back to Top

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 0910-0256. Also include the FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Back to Top

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

SUPPLEMENTARY INFORMATION: Back to Top

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—21 CFR Parts 106 and 107 (OMB Control Number 0910-0256)—Extension Back to Top

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 parts 106 and 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), FDA proposed changes in the infant formula regulations, including some of those listed in tables 1, 2, and 3 of this document. The document 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 May 4, 2010 (75 FR 23777), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

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

Table 1.—Estimated Annual Reporting Burden 1 Back to Top
Federal Food, Drug, and Cosmetic Act or 21 CFR Section No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours
1There are no capital costs or operating and maintenance costs associated with this collection of information.
Section 412(d) of the act 5 13 65 10 650
21 CFR 106.120(b) 1 1 1 4 4
21 CFR 107.50(b)(3) and (b)(4) 3 2 6 4 24
21 CFR 107.50(e)(2) 1 1 1 4 4
Total 682        
Table 2.—Estimated Annual Recordkeeping Burden 1 Back to Top
21 CFR Section No. of Recordkeepers Annual Frequency per Recordkeeping Total Annual Records Hours per Record Total Hours
1There are no capital costs or operating and maintenance costs associated with this collection of information.
106.100 5 10 50 400 20,000
107.50(c)(3) 3 10 30 300 9,000
Total 29,000        
Table 3.—Estimated Annual Third Party Disclosure Burden 1 Back to Top
21 CFR Section No. of Respondents Annual Frequency of Disclosure Total Annual Disclosures Hours per Disclosure Total Hours
1There are no capital costs or operating and maintenance costs associated with this collection of information.
107.10(a) and 107.20 5 13 65 8 520

In compiling these estimates, FDA consulted its records of the number of infant formula submissions received in the past. All infant formula submissions to FDA may be provided in electronic format. The hours per response reporting estimates are based on FDA's experience with similar programs and information received from industry.

FDA estimates that it will receive 13 reports from 5 manufacturers annually under section 412(d) of the act, for a total annual response of 65 reports. Each report is estimated to take 10 hours per response for a total of 650 hours. FDA also estimates that it will receive one notification under § 106.120(b). The notification is expected to take 4 hours per response, for a total of 4 hours.

For exempt infant formula, FDA estimates that it will receive 2 reports from 3 manufacturers annually under §§ 107.50(b)(3) and (b)(4), for a total annual response of 6 reports. Each report is estimated to take 4 hours per response for a total of 24 hours. FDA also estimates that it will receive one notification under § 107.50(e)(2). The notification is expected to take four hours per response, for a total of four hours.

FDA estimates that 5 firms will expend approximately 20,000 hours per year to fully satisfy the recordkeeping requirements in § 106.100. It is estimated that 3 firms will expend approximately 9,000 hours per year to fully satisfy the recordkeeping requirements in § 107.50(c)(3).

FDA estimates that compliance with the labeling requirements of §§ 107.10(a) and 107.20 will require 520 hours annually by 5 manufacturers.

Dated: August 5, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.

[FR Doc. 2010-19640 Filed 8-9-10; 8:45 am]

BILLING CODE 4160-01-S

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