00-28852. Agency Information Collection Activities; Submission for OMB Review; Comment Request; Infant Formula Requirements

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

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.

DATES:

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

ADDRESSES:

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.

FOR FURTHER INFORMATION CONTACT:

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

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: (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 Section	No. of ­Respondents	Annual ­Frequency per ­Response	Total Annual Responses	Hours per ­Response	Total Hours
Section 412(d) of the act	4	7	28	10	280
106.120(b)	4	0.25	1	4	4
107.10(a) and 107.20	4	7	28	8	224
107.50(b)(3) and (b)(4)	3	4	12	4	48
107.50(e)(2)	3	0.33	1	4	4
Total					560
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 2.—Estimated Annual Recordkeeping Burden¹

21 CFR Section	No. of ­Recordkeepers	Annual ­Frequency per Recordkeeping	Total Annual Records	Hours per ­Recordkeeper	Total Hours
106.100	4	10	40	4,000	16,000
107.50(c)(3)	3	10	30	3,000	9,000
Total					25,000
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.

Dated: November 6, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.