[Federal Register Volume 72, Number 57 (Monday, March 26, 2007)]
[Notices]
[Pages 14116-14118]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-5470]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0528]


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

[[Page 14117]]

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 April 
25, 2007.

ADDRESSES: 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: FDA Desk Officer, 
FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief 
Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4659.

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 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 CFR part 106 and part 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 notice 
of proposed rulemaking published in the Federal Register of July 9, 
1996 (61 FR 36154) (the 1996 proposed rule), FDA proposed changes in 
the infant formula regulations, including some of those listed in 
tables 1 and 2 of this document. The 1996 proposed rule 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 January 12, 2007 (72 FR 1539), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received. The notice 
incorrectly reported the ``Hours per Record'' and the ``Total Hours'' 
for 21 CFR 106.100 and 107.50(c)(3) in Table 2. Table 2 of this 
document contains the correct burden estimate.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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  Federal Food, Drug, and
  Cosmetic Act or 21 CFR        No. of       Annual Frequency     Total Annual       Hours per      Total Hours
          Section             Respondents      per Response       Responses\2\       Response
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Section 412(d) of the act                5                 13                 65              10             650
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106.120(b)                               1                  1                  1               4               4
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107.10(a) and 107.20                     5                 13                 65               8             520
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107.50(b)(3) and (b)(4)                  3                  2                  6               4              24
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107.50(e)(2)                             1                  1                  1               4               4
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Total                       ..............  .................  .................  ..............           1,202
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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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                         No. of         Annual Frequency        Total Annual         Hours per
  21 CFR Section     Recordkeepers      per Recordkeeping        Records\2\           Record        Total Hours
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106.100                            5                    10                    50             400          20,000
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107.50 (c)(3)                      3                    10                    30             300           9,000
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Total              .................  ....................  ....................  ..............          29,000
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.



[[Page 14118]]

    Dated: March 20, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-5470 Filed 3-23-07; 8:45 am]
BILLING CODE 4160-01-S