
[Federal Register Volume 78, Number 191 (Wednesday, October 2, 2013)]
[Notices]
[Pages 60883-60884]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-24046]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0545]


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 
November 1, 2013.

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: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0256 and 
title ``Infant Formula Requirements.'' Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, PRAStaff@fda.hhs.gov.

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 FD&C 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 FD&C Act (21 
U.S.C. 350a) requires manufacturers of infant formula to establish and 
adhere to quality control procedures, notify us when a batch of infant 
formula that has left the manufacturers' control may be adulterated or 
misbranded, and keep records of distribution. We have issued 
regulations to implement the FD&C Act's requirements for infant formula 
in parts 106 and 107 (21 CFR parts 106 and 107). We also regulate the 
labeling of infant formula under the authority of section 403 of the 
FD&C Act (21 U.S.C. 343). Under our 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), we proposed changes in our 
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 
Federal Register of April 28, 2003 (68 FR 22341) (the 2003 reopening), 
FDA reopened the comment period for the proposed rule. Interested 
persons were originally given until June 27, 2003, to comment on these 
issues and the 1996 proposal. However, in response to a request, the 
comment period was extended to August 26, 2003 (68 FR 38247, June 27, 
2003). FDA again reopened the comment period on August 1, 2006 (71 FR 
43392) (the 2006 reopening) for 45 days to accept comment on a limited 
set of issues. In a notice of proposed rulemaking published in the 
Federal Register of April 16, 2013 (78 FR 22442), we proposed to amend 
our regulations on nutrient specifications and labeling for infant 
formula to add the mineral selenium to the list of required nutrients 
and to establish minimum and maximum levels of selenium in infant 
formula. The document also included revised burden estimates for the 
proposed changes and solicited public comment. In the interim, FDA is 
seeking an extension of OMB approval for the current regulations so 
that we can continue to collect information while the proposals are 
pending. Accordingly, in the Federal Register of May 16, 2013 (78 FR 
28854), FDA published a 60-day notice requesting public comment on the 
proposed extension of this collection of information. No comments were 
received.
    We estimate the burden of this collection of information as 
follows:

[[Page 60884]]



                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
Federal Food, Drug, and Cosmetic     Number of     responses per   Total annual     burden per      Total hours
      Act or 21 CFR Section         respondents     respondent       responses       response
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Section 412(d) of the FD&C Act..               5              13              65              10             650
21 CFR 106.120(b)...............               1               1               1               4               4
21 CFR 107.50(b)(3) and (b)(4)..               3               2               6               4              24
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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                                                     Number of                        Average
         21 CFR Section              Number of      records per    Total annual     burden per      Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
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106.100.........................               5              10              50             400          20,000
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.


                                               Table 3--Estimated Annual Third Party Disclosure Burden \1\
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                                                                                         Number of
                           21 CFR Section                               Number of     disclosures per    Total annual    Average burden    Total hours
                                                                       respondents       respondent      disclosures     per disclosure
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21 CFR 107.10(a) and 107.20........................................               5               13               65                8              520
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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, we consulted our records of the 
number of infant formula submissions received in the past. All infant 
formula submissions may be provided to us in electronic format. The 
hours per response reporting estimates are based on our experience with 
similar programs and information received from industry.
    We estimate that we will receive 13 reports from 5 manufacturers 
annually under section 412(d) of the FD&C 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. We also estimate that we will 
receive one notification under Sec.  106.120(b). The notification is 
expected to take four hours per response, for a total of four hours.
    For exempt infant formula, we estimate that we will receive 2 
reports from 3 manufacturers annually under Sec. Sec.  107.50(b)(3) and 
(b)(4), for a total annual response of 6 reports. Each report is 
estimated to take 4 hours per response for a total of 24 hours. We also 
estimate that we will receive one notification annually under Sec.  
107.50(e)(2) and that the notification will take 4 hours to prepare.
    We estimate that 5 firms will expend approximately 20,000 hours per 
year to fully satisfy the recordkeeping requirements in Sec.  106.100 
and that 3 firms will expend approximately 9,000 hours per year to 
fully satisfy the recordkeeping requirements in Sec.  107.50(c)(3).
    We estimate compliance with our labeling requirements in Sec. Sec.  
107.10(a) and 107.20 requires 520 hours annually by 5 manufacturers.

    Dated: September 26, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-24046 Filed 10-1-13; 8:45 am]
BILLING CODE 4160-01-P


