[Federal Register Volume 78, Number 95 (Thursday, May 16, 2013)]
[Notices]
[Pages 28854-28856]
From the Federal Register Online via the Government Publishing 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, [email protected].
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