FDA`s regulations in part 120(21 CFR
part 120) mandate the application of HACCP procedures to fruit and
vegetable juice processing. HACCP is a preventive system of hazard
control that can be used by all food processors to ensure the
safety of their products to consumers. A HACCP system of preventive
controls is the most effective and efficient way to ensure that
these food products are safe. FDA's mandate to ensure the safety of
the nation`s food supply is derived principally from the Federal
Food Drug and Cosmetic Act (the FD&C Act) (21 U.S.C. 321, et
seq.). Under the Act, FDA has authority to ensure that all foods in
interstate commerce, or that have been shipped in interstate
commerce, are not misbranded or deceptively packaged; under section
701 (21 U.S.C. 371), the Act authorizes the Agency to issue
regulations for its efficient enforcement. The Agency also has
authority under section 361 of the Public Health Service Act (42
U.S.C. 264) to issue and enforce regulations to prevent the
introduction, transmission, or spread of communicable diseases from
one State to another State.
This collection of information
has increased by 1,560 respondents, 1,716 responses, and 102,960
hours. This adjustment in burden is a result of an error that
occurred with the last submission of extension. The recordkeeping
burden requirement for writing an HACCP plan under sections
120.8(a), 120.8(b), and 120.12(a)(3), (b) and (c) was inadvertently
left off of the burden chart in Item 12 in the supporting statement
(but was included in the write up in Item 1). The adjusted total
burden requested is now 461,426 recordkeeping hours (358,466
previous recordkeeping hours plus 102,960 new recordkeeping hours).
The previously approved ICR submitted to OMB included eight ICs
entered in ROCIS. Upon this submission, we added one IC (left out
of the previous submission for extension, in error). With this
submission we have also consolidated four of the ICs into two ICs.
Therefore, for this submission of extension this ICR now has seven
ICs. The information collection activities and the burden
associated with each IC, however, remain broken down in this
supporting statement and in the table in Item 12.
$44,150
No
No
No
No
No
Uncollected
Ila Mizrachi 301 796-7726
ila.mizrachi@fda.hhs.gov
No
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.