Document ID: FDA-2013-N-0545-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Requirements
Posted Date: 2013-05-16T04:00Z

[Federal Register Volume 78, Number 95 (Thursday, May 16, 2013)]
[Notices]
[Pages 28854-28856]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-11631]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

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 or we) is announcing an 
opportunity for public comment on our proposed collection of certain 
information. 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 information, and to 
allow 60 days for public comment in response to the notice. This notice 
invites comments on the information collection provisions of our infant 
formula regulations, including infant formula labeling, quality control 
procedures, notification requirements, and recordkeeping.

DATES: Submit either electronic or written comments on the collection 
of information by July 15, 2013.

[[Page 28855]]

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: Domini Bean, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400T, 
Rockville, MD 20850, domini.bean@fda.hhs.gov.

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, we are publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, we invite 
comments on these topics: (1) Whether the proposed collection of 
information is necessary for the proper performance of our functions, 
including whether the information will have practical utility; (2) the 
accuracy of our 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 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. 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.
    We estimate the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
Federal food, drug, and cosmetic     Number of     responses per   Total annual   Average burden    Total hours
      act or 21 CFR section         respondents     respondent       responses     per response
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Section 412(d) of the FD&C Act..               5              13              65              10             650
Sec.   106.120(b)...............               1               1               1               4               4
Sec.   107.50(b)(3) and (b)(4)..               3               2               6               4              24
Sec.   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 burden
         21 CFR Section              Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
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Sec.   106.100..................               5              10              50             400          20,000
Sec.   107.50(c)(3).............               3              10              30             300           9,000
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[[Page 28856]]

 
    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    Total annual   Average burden    Total hours
                                    respondents   per respondent    disclosures   per disclosure
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Sec.  Sec.   107.10(a) and                     5              13              65               8             520
 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, 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 4 hours per response, for a total of 4 hours.
    For exempt infant formula, we estimate that we will receive two 
reports from three manufacturers annually under Sec. 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. 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: May 9, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-11631 Filed 5-15-13; 8:45 am]
BILLING CODE 4160-01-P