[Federal Register Volume 61, Number 210 (Tuesday, October 29, 1996)]
[Notices]
[Pages 55805-55806]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-27746]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96N-0325]
Agency Information Collection Activities; Submission for OMB
Review; Comment Request
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that the
proposed collection of information listed below has been submitted to
the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.
DATES: Submit written comments on the collection of information by
November 29, 1996.
ADDRESSES: Submit written comments on the collection of information to
the Office of Information and Regulatory Affairs, OMB, New Executive
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503,
Attention: Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT: Charity B. Smith, Office of
Information Resources Management (HFA-250), Food and Drug
Administration, 5600 Fishers Lane, Rockville, rm. 16B-19, MD 20857,
301-827-1686.
SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507), FDA has submitted the
following proposed collection of information to OMB for review and
clearance: 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--Reinstatement).
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
[[Page 55806]]
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 C. 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's 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 FDA using Form FDA 2541 (Secs. 108.25(c)(1) and 108.35(c)(1) (21
CFR 108.25(c)(1) and 108.35(c)(1))). 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 (Secs. 108.25(c)(2) and
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 and procedures must be
posted near the processing equipment or made available to the operator
(Sec. 113.87(a) (21 CFR 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: (1) Document
corrective actions when process controls and procedures do not fall
within specified limits (Secs. 113.89, 114.89, and 114.100(c)); (2)
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), 108.35(d),
and (e)); and (3) 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 low-acid foods) and 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:
Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
Annual
Form No. 21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
----------------------------------------------------------------------------------------------------------------
Form FDA 2541
(Registratio
n) 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
Total 7,300 2,591
----------------------------------------------------------------------------------------------------------------
Estimated Annual Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR Part No. of Frequency per Total Annual Hours per Total Hours
Recordkeepers Recordkeeping Records Recordkeeper
----------------------------------------------------------------------------------------------------------------
108, 113, and 114 5,388 1 5,388 250 1,347,000
----------------------------------------------------------------------------------------------------------------
There are no capital costs or operating and maintenance costs associated with this collection.
The reporting burden for Secs. 108.25(d) and 108.35(d) and (e) is
insignificant 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. No burden has been
estimated for the coding requirements in Secs. 113.60(c) and 114.80(b)
because coding is a usual and customary practice in the foods industry
for liability purposes, inventory control, and process control in the
event of a problem with the product. Under 5 CFR 1320.3(b)(2), the
time, effort, and financial resources necessary to comply with a
collection of information are excluded from the burden estimate if the
reporting, recordkeeping, or disclosure activities needed to comply are
usual and customary because they would occur in the normal course of
activities.
Dated: October 23, 1996.
William K. Hubbard,
Associate Commissioner for Policy.
[FR Doc. 96-27746 Filed 10-28-96; 8:45 am]
BILLING CODE 4160-01-F
