[Federal Register: October 17, 2003 (Volume 68, Number 201)]
[Notices]
[Page 59793-59794]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17oc03-51]
-----------------------------------------------------------------------
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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