[Federal Register Volume 75, Number 153 (Tuesday, August 10, 2010)]
[Notices]
[Pages 48350-48351]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-19640]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0190]
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
September 9, 2010.
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 e-mailed to [email protected]. All
comments should be identified with the OMB control number 0910-0256.
Also include the FDA 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: 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 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.
In the Federal Register of May 4, 2010 (75 FR 23777), FDA published
a 60-day notice requesting public comment on the proposed collection of
information. No comments were received.
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.
[[Page 48351]]
Table 2.--Estimated Annual Recordkeeping Burden\1\
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No. of Annual Frequency Total Annual
21 CFR 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(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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No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents of Disclosure Disclosures Disclosure Total Hours
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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, 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 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. FDA
also estimates that it will receive one notification under Sec.
107.50(e)(2). The notification is expected to take four hours per
response, for a total of four hours.
FDA estimates that 5 firms will expend approximately 20,000 hours
per year to fully satisfy the recordkeeping requirements in Sec.
106.100. It is estimated that 3 firms will expend approximately 9,000
hours per year to fully satisfy the recordkeeping 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: August 5, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-19640 Filed 8-9-10; 8:45 am]
BILLING CODE 4160-01-S