Document ID: FDA-2010-N-0190-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Infant Formula Requirements
Posted Date: 2010-05-04T04:00Z

[Federal Register: May 4, 2010 (Volume 75, Number 85)]
[Notices]               
[Page 23777-23779]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04my10-92]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0190]

 
Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of

[[Page 23778]]

information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on information collection 
regarding the manufacture of infant formula, including infant formula 
labeling, quality control procedures, notification requirements, and 
recordkeeping.

DATES:  Submit written or electronic comments on the collection of 
information by July 6, 2010.

ADDRESSES:  Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Denver Presley, Jr., Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3793.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

 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 
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 notice of 
proposed rulemaking 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, 2, and 3 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.
    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
                       Section                            Respondents        per  Response         Responses           Response           Total Hours
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Section 412(d) of the act                                              5                  13                  65                  10                 650
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21 CFR 106.120(b)                                                      1                   1                   1                   4                   4
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21 CFR 107.50(b)(3) and (b)(4)                                         3                   2                   6                   4                  24
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21 CFR 107.50(e)(2)                                                    1                   1                   1                   4                   4
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Total                                                                                                                                                682
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                               Table 2.--Estimated Annual Recordkeeping Burden\1\
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   21 CFR           No. of         Annual Frequency      Total Annual
   Section       Recordkeepers    per  Recordkeeping        Records        Hours per  Record      Total Hours
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106.100                        5                  10                  50                 400              20,000
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107.50                         3                  10                  30                 300               9,000
 (c)(3)
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[[Page 23779]]

Total                                                                                                     29,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                                Table 3.--Third Party Disclosure Requirements\1\
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   21 CFR           No. of         Annual Frequency      Total Annual          Hours per
   Section        Respondents        of Disclosure        Disclosures         Disclosure          Total Hours
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21 CFR                         5                  13                  65                   8                 520
 107.10(a)
 and 107.20
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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. All infant 
formula submissions to FDA may be provided in electronic format. The 
hours per response reporting estimates are based on FDA's experience 
with similar programs and information received from industry.
    FDA estimates that it will receive 13 reports from 5 manufacturers 
annually under section 412(d) of the act, for a total annual response 
of 65 reports. Each report is estimated to take 10 hours per response 
for a total of 650 hours. FDA also estimates that it will receive one 
notification under Sec.  106.120(b). The notification is expected to 
take 4 hours per response, for a total of 4 hours.
    For exempt infant formula, FDA estimates that it will receive two 
reports from three manufacturers annually under Sec.  107.50(b)(3) and 
(b)(4), for a total annual response of six reports. Each report is 
estimated to take 4 hours per response for a total of 24 hours. FDA 
also estimates that it will receive one notification under Sec.  
107.50(e)(2). The notification is expected to take 4 hours per 
response, for a total of 4 hours.
    FDA estimates that 5 firms will expend approximately 20,000 hours 
per year to fully satisfy the record keeping requirements in Sec.  
106.100. It is estimated that 3 firms will expend approximately 9,000 
hours per year to fully satisfy the record keeping requirements in 
Sec.  107.50(c)(3).
    FDA estimates that compliance with the labeling requirements of 
Sec. Sec.  107.10(a) and 107.20 will require 520 hours annually by 5 
manufacturers.

    Dated: April 28, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-10360 Filed 5-3-10; 8:45 am]
BILLING CODE 4160-01-S