[Federal Register Volume 61, Number 91 (Thursday, May 9, 1996)]
[Notices]
[Pages 21192-21193]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-11515]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0115]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Extension
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,
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 reporting and recordkeeping requirements for firms
that process acidified foods and thermally processed low-acid foods in
hermetically sealed containers.
DATES: Submit written comments on the collection of information by July
8, 1996.
ADDRESSES: Submit written comments on the collection of information to
the Dockets Management Branch (HFA-305), Food and Drug Administration,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should
be identified with the docket number found in brackets in the heading
of this document.
FOR FURTHER INFORMATION CONTACT: Charity B. Smith, Office of
Information Resources Management (HFA-250), Food and Drug
Administration, 5600 Fishers Lane, rm. 16B-19, Rockville, MD 20857,
301-827-1686.
SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 (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. ``Collection of
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c). To
comply with this requirement, FDA is publishing notice of the proposed
collection of information listed below.
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.
Food Canning Establishment Registration, Process Filing and
Recordkeeping for Acidified Foods and Thermally Processed Low-Acid
Foods in Hermetically Sealed Containers (21 CFR 108.25(c)(1) and
(c)(2), (d), (e), (g); 108.35(c)(1), (c)(2), (d), (e), (f), (h);
113.60(c); 113.83; 113.87; 113.89; 113.100; 114.80(b); 114.89;
114.100(a) through (d)) (OMB Control Number 0910-0037--Extension).
Under the Federal Food, Drug, and Cosmetic Act (the act), FDA is
authorized to prevent the interstate distribution of food products that
may be injurious to health or that are otherwise adulterated, as
defined in section 402 of the act (21 U.S.C. 342). Under the authority
granted to FDA by section 404 of the act (21 U.S.C. 344), FDA
regulations require registration of food processing establishments,
filing of process or other data, and maintenance of processing and
production records for acidified foods and thermally processed low-acid
foods in hermetically sealed containers. These requirements are
intended to ensure safe manufacturing, processing, and packing
procedures and to permit FDA to verify that these procedures are being
followed. Improperly processed low-acid foods present life-threatening
hazards if contaminated with foodborne microorganisms, especially
Clostridium botulinum. The spores of Clostridium botulinum must be
destroyed or inhibited to avoid production of the deadly toxin that
causes botulism. This is accomplished with good manufacturing
procedures, which must include the use of adequate heat processes or
other means of preservation.
To protect the public health, FDA regulations require that each
firm that manufactures, processes, or packs acidified foods or
thermally processed low-acid foods in hermetically sealed containers
for introduction into interstate commerce register the establishment
with the Food and Drug Administration using Form FDA 2541 (21 CFR
108.25(c)(1) and 108.35(c)(2)). In addition to registering the plant,
each firm is required to provide data on the processes used to produce
these foods, using Form FDA 2541a for all methods except aseptic
processing, or Form FDA 2541c for aseptic processing of low-acid foods
in hermetically sealed containers (21 CFR 108.25(c)(2), 108.35(c)(2)).
Plant registration and process filing may be accomplished
simultaneously. Process data must be filed prior to packing any new
product, and operating processes
[[Page 21193]]
and procedures must be posted near the processing equipment or made
available to the operator (Sec. 113.87(a)).
Regulations in parts 108, 113, and 114 (21 CFR parts 108, 113, and
114) require firms to maintain records showing adherence to the
substantive requirements of the regulations. These records must be made
available to FDA on request. Firms are also required to document
corrective actions when process controls and procedures do not fall
within specified limits (Secs. 113.89, 114.89, and 114.100(c)); to
report any instance of potential health-endangering spoilage, process
deviation, or contamination with microorganisms where any lot of the
food has entered distribution in commerce (Secs. 108.25(d) and
108.35(d) and (e)); and to develop and keep on file plans for recalling
products that may endanger the public health (Secs. 108.25(e) and
108.35(f)). To permit lots to be traced after distribution, acidified
foods and thermally processed low-acid foods in hermetically sealed
containers must be marked with an identifying code (Secs. 113.60(c)
(thermally processed foods), 114.80(b) (acidified foods)).
FDA estimates the burden of complying with the information
collection provisions of the agency's regulations for acidified foods
and thermally processed low-acid foods in hermetically sealed
containers as follows:
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Estimated Annual Reporting Burden
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Annual
Form No. CFR Section No. of Frequency Total Annual Hours Per Total
Respondents per Response Responses Response Hours
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Form FDA 2541
(Registration) 108.25(c)(1) and
108.35(c)(1) 300 1 300 .17 51
Form FDA 2541a (Process
Filing) 108.25(c)(2) and
108.35(c)(2) 1,000 6.5 6,500 .333 2,165
Form FDA 2541c (Process
Filing) 108.35(c)(2) 1,000 .50 500 .75 375
113.60(c) ? ? ? ? ?
114.80(b) ? ? ? ? ?
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Where question marks appear in the burden estimates, FDA does not have current information available. Public
comments will be greatly appreciated.
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Estimated Annual Recordkeeping Burden
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Annual Frequency per
21 CFR Section No. of Recordkeepers Recordkeeping Total Annual Records Hours Per Recordkeeper Total Hours
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21 CFR Parts 108, 5,388 1 5,388 250 1,347,000
113, 114
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There are no capital or operating and maintenance costs associated with this collection.
The reporting burden for Secs. 108.25(d) and 108.35(d) and (e)
isinsignificant because notification of spoilage, process deviation, or
contamination of product in distribution occurs less than once a year.
Most firms discover these problems before the product is distributed
and, therefore, are not required to report the occurrence. To avoid
double-counting, estimates for Secs. 108.25(g) and 108.35(h) have not
been included because they merely cross-reference recordkeeping
requirements contained in parts 113 and 114.
Dated: May 1, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-11515 Filed 5-8-96; 8:45 am]
BILLING CODE 4160-01-F
