[Federal Register Volume 65, Number 161 (Friday, August 18, 2000)]
[Notices]
[Pages 50539-50540]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-21009]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1441]


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) 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, and to 
allow 60 days for public comment in response to the notice. This notice 
solicits comments on information collection regarding the manufacturer 
of infant formula, including infant formula labeling, quality control 
procedures, notification requirements, and recordkeeping.

DATES: Submit written comments on the collection of information by 
October 17, 2000.

ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (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 Schlosburg, Office of 
Information Resources Management (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 a proposed 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: (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 (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

[[Page 50540]]

is to ensure that consumers have the information they need to prepare 
and use infant formula appropriately. In a document 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 information. 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\
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                                                      Annual
Federal Food, Drug, and Cosmetic     Number of     frequency per   Total annual      Hours per      Total hours
 Act (the act) or 21 CFR section    respondents      response        responses       response
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Section 412(d) of the act.......               4            7                 28              10             280
106.120(b)......................               4            0.25               1               4               4
107.10(a) and 107.20............               4            7                 28               8             224
107.50(b)(3) and (b)(4).........               3            4                 12               4              48
107.50(e)(2)....................               3            0.33               1               4               4
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    Total.......................  ..............  ..............  ..............  ..............            560
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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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                                                      Annual
         21 CFR section              Number of     frequency of    Total annual      Hours per      Total hours
                                   recordkeepers   recordkeeping      records         record
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106.100.........................               4              10              40           4,000          16,000
107.50(c)(3)....................               3              10              30           3,000           9,000
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    Total.......................  ..............  ..............  ..............  ..............         25,000
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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: August 11, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-21009 Filed 8-17-00; 8:45 am]
BILLING CODE 4160-01-M