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Agency Information Collection Activities; Submission for OMB Review; Comment Request; Infant Formula Requirements

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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Food and Drug Administration, HHS.




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


Submit written comments on the collection of information by December 11, 2000.


Submit written comments on the collection of information to the Office of Information and Regulatory Affairs, OMB, New Executive Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: Wendy Taylor, Desk Officer for FDA.

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Peggy Schlosburg, Office of Information Resources Management (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

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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: (1) Establish and adhere to quality control procedures, (2) notify FDA when a batch of infant formula that has left the manufacturers' control may be adulterated or misbranded, and (3) 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 document 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 and 2 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 August 18, 2000 (65 FR 50539), the agency requested comments 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 Burden1

Federal Food, Drug, and Cosmetic Act (the Act) or 21 CFR SectionNo. of ­RespondentsAnnual ­Frequency per ­ResponseTotal Annual ResponsesHours per ­ResponseTotal Hours
Section 412(d) of the act472810280
107.10(a) and 107.2047288224
107.50(b)(3) and (b)(4)3412448
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
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Table 2.—Estimated Annual Recordkeeping Burden1

21 CFR SectionNo. of ­RecordkeepersAnnual ­Frequency per RecordkeepingTotal Annual RecordsHours per ­RecordkeeperTotal Hours
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

In compiling these estimates, FDA consulted its records of the number of infant formula submissions received in the past. The figures for hours per response are based on estimates from experienced persons in the agency and in industry.

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Dated: November 6, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

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[FR Doc. 00-28852 Filed 11-8-00; 8:45 am]