[Federal Register Volume 65, Number 218 (Thursday, November 9, 2000)]
[Notices]
[Pages 67388-67389]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-28852]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1441]


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

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.

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
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                                                      Annual
Federal Food, Drug, and Cosmetic      No. of       Frequency per   Total Annual      Hours per      Total Hours
 Act (the Act) or 21 CFR Section    Respondents      Response        Responses       Response
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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
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 67389]]


                                Table 2.--Estimated Annual Recordkeeping Burden1
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                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                   Recordkeepers   Recordkeeping      Records      Recordkeeper
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106.100                                 4              10              40           4,000          16,000
107.50(c)(3)                            3              10              30           3,000           9,000
Total                                                                                             25,000
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\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.
[FR Doc. 00-28852 Filed 11-8-00; 8:45 am]
BILLING CODE 4160-01-F