[Federal Register Volume 69, Number 8 (Tuesday, January 13, 2004)]
[Notices]
[Pages 1985-1986]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-670]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0463]


Agency Information Collection Activities; Submission for Office 
of Management and Budget 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 a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
February 12, 2004.

ADDRESSES: The Office of Management and Budget (OMB) is still 
experiencing significant delays in the regular mail, including first 
class and express mail, and messenger deliveries are not being 
accepted. 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: Fumie Yokota, Desk 
Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management 
Programs (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--21 CFR Parts 106 and 107 (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 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 
21

[[Page 1986]]

CFR part 106 and part 107 (21 CFR part 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 that 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 October 17, 2003 (68 FR 59793) FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden for this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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   Federal Food, Drug, and                         Annual
   Cosmetic Act or 21 CFR          No. of       Frequency per    Total Annual      Hours per       Total Hours
           Section              Respondents       Response       Responses\2\       Response
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Section 412(d) of the act                   4           13                  52               10              520
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106.120(b)                                  4            0.25                1                4                4
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107.10(a) and 107.20                        4           13                  52                8              416
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107.50(b)(3) and (b)(4)                     3            2                   6                4               24
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107.50(e)(2)                                3            0.33                1                4                4
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  Total                                                                                                      968
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Manufacturers may submit infant formula notifications in electronic format.


                               Table 2.--Estimated Annual Recordkeeping Burden\1\
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                                                   Annual
       21 CFR Section             No. of        Frequency of     Total Annual      Hours per       Total Hours
                              Recordkeepers    Recordkeeping       Records        Recordkeeper
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106.100                                    4               10               40            4,000          160,000
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107.50(c)(3)                               3               10               30            3,000           90,000
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  Total                                                                                                  250,000
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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: January 6, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-670 Filed 1-12-04; 8:45 am]
BILLING CODE 4160-01-S