[Federal Register Volume 68, Number 201 (Friday, October 17, 2003)]
[Notices]
[Pages 59793-59794]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-26284]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0463]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Infant Formula Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. 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 solicits comments on information collection 
regarding the manufacture of infant formula, including infant formula 
labeling, quality control procedures, notification requirements, and 
recordkeeping.

DATES: Submit written or electronic comments on the collection of 
information by December 16, 2003.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.fda.gov/dockets/ecomments. 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: Peggy Robbins, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1223.

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, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's 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 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

[[Page 59794]]

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 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 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.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                                                                       Annual
    Federal Food, Drug, and  Cosmetic Act or 21 CFR        No. of    Frequency  Total Annual  Hours per   Total
                        Section                         Respondents      per                   Response   Hours
                                                                      Response  Responses\2\
----------------------------------------------------------------------------------------------------------------
Section 412(d) of the act                                       4          13           52          10      520
----------------------------------------------------------------------------------------------------------------
106.120(b)                                                      4        0.25            1           4        4
----------------------------------------------------------------------------------------------------------------
107.10(a) and 107.20                                            4          13           52           8      416
----------------------------------------------------------------------------------------------------------------
107.50(b)(3) and (b)(4)                                         3           2            6           4       24
----------------------------------------------------------------------------------------------------------------
107.50(e)(2)                                                    3        0.33            1           4        4
----------------------------------------------------------------------------------------------------------------
Total                                                                                                       968
----------------------------------------------------------------------------------------------------------------
\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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                              Annual Frequency  of                               Hours per         Total
                   21 CFR Section                     No. of  Recordkeepers      Recordkeeping      Total Annual  Records       Recordkeeper       Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
106.100                                                                  4                     10                     40                  4,000   160,00
                                                                                                                                                      0
--------------------------------------------------------------------------------------------------------------------------------------------------------
107.50(c)(3)                                                             3                     10                     30                  3,000   90,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                                                                             250,00
                                                                                                                                                      0
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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: October 9, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-26284 Filed 10-16-03; 8:45 am]
BILLING CODE 4160-01-S