Source: https://www.federalregister.gov/articles/2010/08/10/2010-19640/agency-information-collection-activities-submission-for-office-of-management-and-budget-review
Timestamp: 2016-05-02 12:35:18
Document Index: 449012426

Matched Legal Cases: ['arts 106', 'arts 106', 'arts 106', 'art 107', '§ 106', '§ 107', '§ 107', '§ 106', '§ 107', '§ 107']

Federal Register | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infant Formula Requirements
Publication Date: Tuesday, August 10, 2010
Dates: Fax written comments on the collection of information by September 9, 2010.
Comments Close: 09/09/2010
75 FR 48350
-48351 (2 pages)
Docket No. FDA-2010-N-0190
Document Number: 2010-19640
Shorter URL: https://federalregister.gov/a/2010-19640 Action
Table 3.—Estimated Annual Third Party Disclosure Burden
Fax written comments on the collection of information by September 9, 2010.
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.
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.
Section 412(d) of the act
21 CFR 106.120(b)
21 CFR 107.50(b)(3) and (b)(4)
21 CFR 107.50(e)(2)
107.50(c)(3)
Annual Frequency of Disclosure
107.10(a) and 107.20
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.
[FR Doc. 2010-19640 Filed 8-9-10; 8:45 am]