The FDA announced in the July 26, 2016 Federal Register that it is seeking public comment on a notice regarding the paperwork and burdens associated with record information and importer verification to ensure that hazards have been avoided in their HACCP plan. FDA has included a table in the Federal Register summarizing the estimated burden for documenting and maintaining records in hours for:
• Hazard analysis and HACCP plan preparation and reassessment records
• Critical Control Monitoring records, Corrective Action, Calibration, Sanitation Control, and Verification
• Verifying compliance of imports and preparation of records and and written verification activities and procedures.
With respect to the collection of Seafood HACCP record 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.
You may submit electronic or written comments on “the collection of information” related to seafood HACCP recordkeeping by September 26, 2016. Details on how to submit your comments publicly or confidentially are described in the Federal Register: https://www.gpo.gov/fdsys/pkg/FR-2016-07-26/html/2016-17571.htm
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.