[Federal Register: January 13, 2004 (Volume 69, Number 8)]
[Notices]
[Page 1985-1986]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13ja04-49]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0463]
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
February 12, 2004.
ADDRESSES: The Office of Management and Budget (OMB) is still
experiencing significant delays in the regular mail, including first
class and express mail, and messenger deliveries are not being
accepted. 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: Fumie Yokota, Desk
Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1223.
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
21
[[Page 1986]]
CFR part 106 and part 107 (21 CFR part 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 that 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 and 2 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 October 17, 2003 (68 FR 59793) FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden for this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Federal Food, Drug, and Annual
Cosmetic Act or 21 CFR No. of Frequency per Total Annual Hours per Total Hours
Section Respondents Response Responses\2\ Response
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Section 412(d) of the act 4 13 52 10 520
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106.120(b) 4 0.25 1 4 4
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107.10(a) and 107.20 4 13 52 8 416
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107.50(b)(3) and (b)(4) 3 2 6 4 24
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107.50(e)(2) 3 0.33 1 4 4
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Total 968
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Manufacturers may submit infant formula notifications in electronic format.
Table 2.--Estimated Annual Recordkeeping Burden\1\
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Annual
21 CFR Section No. of Frequency of Total Annual Hours per Total Hours
Recordkeepers Recordkeeping Records Recordkeeper
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106.100 4 10 40 4,000 160,000
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107.50(c)(3) 3 10 30 3,000 90,000
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Total 250,000
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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. The figures
for hours per response are based on estimates from experienced persons
in the agency and in industry.
Dated: January 6, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-670 Filed 1-12-04; 8:45 am]
BILLING CODE 4160-01-S