[Federal Register Volume 62, Number 244 (Friday, December 19, 1997)] [Notices] [Pages 66634-66635] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 97-33092] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 95N-0309] Agency Information Collection Activities; Submission for OMB Review; Comment Request
Agency
Food and Drug Administration, HHS.
Action
Notice.
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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 (the PRA).
Dates
Submit written comments on the collection of information by January 20, 1998.
Addresses
Submit written comments on the collection of information to Office of Information and Regulatory Affairs, OMB, New Executive Office Bldg., 725 17th St., NW., rm. 10235, Washington, DC 20503, Attn: Desk Officer for FDA.
For Further Information Contact
Margaret R. 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 section 3507 of the PRA (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 106.100, 21 CFR 106.120(b), 21 CFR 107.10(a), 21 CFR 107.20, 21 CFR 107.50(e)(2), 21 CFR 107.50(b)(3), 21 CFR 107.50(b)(4), 21 CFR 107.50(c)(3))--(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 manufacturer's 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 parts 106 and 107. FDA also regulates the labeling of infant formula under the authority of section 403 (21 U.S.C. 343). Under the labeling regulations for infant formula in 21 CFR 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 below. 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. FDA estimates the burden of this collection of information as follows:
Table 1.--Estimated Annual Reporting Burden1 ---------------------------------------------------------------------------------------------------------------- Annual 21 CFR Section No. of Frequency per Total Annual Hours per Total Hours Respondents Response Responses Response ---------------------------------------------------------------------------------------------------------------- 106.120(b) 4 7 28 0 0 107.10(a) 107.20 4 7 28 8 224 107.50(b)(3), (b)(4) 3 4 12 4 48 107.50(e)(2) 3 4 12 0 0 Total 272 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2.--Estimated Annual Recordkeeping Burden1 ---------------------------------------------------------------------------------------------------------------- Annual 21 CFR Section No. of Frequency per Total Annual Hours per Total Hours Recordkeepers Recordkeeping Records Recordkeeper ---------------------------------------------------------------------------------------------------------------- 106.100 4 10 40 4,000 16,000 107.50(c)(3) 4 10 40 0 0 Total 16,000 ---------------------------------------------------------------------------------------------------------------- \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. Because these infant formula regulations implement statutory information collection requirements, only the additional burden attributable to the regulations has been included in the estimates. Due to clerical error, the burden estimates that appeared in FDA's previous notice soliciting comments on this collection of information (62 FR 42256, August 6, 1997) were incorrect. The tables above contain the correct estimates.
Dated: December 10, 1997. William K. Hubbard, Associate Commissioner for Policy Coordination. [FR Doc. 97-33092 Filed 12-18-97; 8:45 am] BILLING CODE 4160-01-F