Current Good Manufacturing
Practice and Hazard Analysis and Risk-Based Preventive Controls For
Human Food and Food for Animals
Extension without change of a currently approved collection
No
Regular
10/29/2024
Requested
Previously Approved
36 Months From Approved
11/30/2024
20,151,907
20,175,345
7,441,861
7,456,374
0
0
This information collection supports
FDA regulations requiring the owner, operator, or agent in charge
of a facility to evaluate the hazards that could affect food
manufactured, processed, packed, or held by the facility; as well
as identify and implement preventive controls, monitor the
performance of those controls, and maintain records of the
monitoring. Respondents to the information collection are owners,
operators, or agents-in-charge of food facilities required to
register under section 415 of the FD&C Act.
The information collection
reflects adjustment. First, with regard to human foods, we removed
the individual element “Reporting: qualified facilities,” as the
attendant burden is captured in the line item “Quality Facility
Attestation.” For animal foods, we combined two individual IC
elements for §§ 507.7(e)(1) and 507.7(e)(2) into one line item for
507.7(e), further decreasing the overall burden by 5,174 hours and
4,334 responses annually. We attribute the latter adjustment to
animal food respondents complying with manufacturing address
disclosures. We also corrected some inadvertent rounding and
calculation errors. Cumulatively the adjustments result in a
decrease of 23,438 responses and 14,513 hours annually to our
estimate.
$50,000
No
No
No
No
No
No
No
Domini Bean 301 796-5733
domini.bean@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.
0751 Preventive controls foods SSA 2024.docx
Disclosures: Food for Animals