supporting statementICRNCRecords11252013[1]

SUPPORTING STATEMENT JUSTIFICATION FOR INDUSTRY

RESPONSES TO NONCOMPLIANCE RECORDS

Terms of Clearance:

This information collection is currently being rolled into the collection for the Public Health Information System. The form for this collection will be made electronically fillable fileable when this package is rolled into the collection for the Public Health Information System (OMB Control Number 0583-0153).

1. Circumstances Making Collection Of Information Necessary:

This information collection requests an extension of the previously approved information collection for Industry Responses to Noncompliance Records

The Food Safety and Inspection Service (FSIS) has been delegated the authority to exercise the functions of the Secretary as provided in the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.), and the Egg Products Inspection Act (EPIA) (21 U.S.C. 1031, et seq.). These statutes mandate that FSIS protect the public by verifying that meat and poultry products are safe, wholesome, not adulterated, and properly labeled and packaged.

If FSIS in-plant personnel discover noncompliances with regulatory requirements they issue Noncompliance Records (NRs). Establishment management has the opportunity to respond in writing.

2. How, By Whom and Purpose Information Is To Be Used:

The following is a discussion of the required information collection and recordkeeping activities.

Responses to Noncompliance Records

The Noncompliance Record, FSIS Form 5400-4, serves as FSIS' official record of noncompliance with one or more regulatory requirements. Inspection program personnel use the form to document their findings and provide written notification of the establishment’s failure to comply with regulatory requirement(s). The establishment management receives a copy of the form and has an opportunity to respond in writing using the Noncompliance Record form. Response by the establishment’s management is voluntary.

There are a total of 136,000 burden hours for the information collection requests relating to establishment responses to receiving a Noncompliance Record.

3. Use Of Improved Information Technology:

FSIS fills out the FSIS 5400-4 and prints off a copy for the establishment. Currently, the establishment manually writes its response to the Noncompliance Record on the form. When FSIS gets the Public Health Information System (PHIS) up and running, establishments will have the option of responding to Noncompliance Records electronically.

4. Efforts To Identify Duplication:

FSIS has determined that these information collections will not duplicate any other information collections. The required records and reports are not available from other sources, either within government or from non-government sources. There is no similar information that can be used or modified.

5. Methods To Minimize Burden On Small Business Entities:

Data collected from small businesses are the same as for large ones. The number of small businesses in this collection is 2,000.

6. Consequences If Information Were Collected Less Frequently:

To conduct the information collections less frequently would reduce the effectiveness of the meat, poultry, and egg products inspection program.

7. Circumstances That Would Cause The Information Collection To Be Conducted In A Manner:

• requiring respondents to report informa­tion to the agency more often than quarterly;

• requiring respondents to prepare a writ­ten response to a collection of infor­ma­tion in fewer than 30 days after receipt of it;

• requiring respondents to submit more than an original and two copies of any docu­ment;

• requiring respondents to retain re­cords, other than health, medical, governm­ent contract, grant-in-aid, or tax records for more than three years;

• in connection with a statisti­cal sur­vey, that is not de­signed to produce valid and reli­able results that can be general­ized to the uni­verse of study;

• requiring the use of a statis­tical data classi­fication that has not been re­vie­wed and approved by OMB;

• that includes a pledge of confiden­tiali­ty that is not supported by au­thority estab­lished in statute or regu­la­tion, that is not sup­ported by dis­closure and data security policies that are consistent with the pledge, or which unneces­sarily impedes shar­ing of data with other agencies for com­patible confiden­tial use; or

• requiring respondents to submit propri­etary trade secret, or other confidential information unless the agency can demon­strate that it has instituted procedures to protect the information's confidentiality to the extent permit­ted by law.

There are no special circumstances that require the collection of information to be inconsistent with 5 CFR 1320.6.

8. Consultation With Persons Outside The Agency:

FSIS published a 60 day notice in the Federal Register (78 FR 23499; September 26, 2013). The Agency received no responses. There was one comment on the 30-day notice, but not relevant to the collection of information.

9. Payment Or Gifts To Respondents:

Respondents do not receive gifts or payments.

10. Confidentiality Provided To Respondents:

No assurances other than routine protection provided under the Freedom of Information Act have been provided to respondents.

11. Questions Of A Sensitive Nature:

The applicants are not asked to furnish any information of a sensitive nature.

12. Estimate Of Burden:

The total estimated burden for this information collection is 136,000 burden hours.

Responses to Noncompliance Reports

FSIS estimates that 6,800 establishments will 20 times a year take an average of 60 minutes to respond to a Noncompliance Record for a total of 136,000 responses and 136,000 hours.

RESPONSES TO NONCOMPLIANCE RECORDS

(FSIS Form 5400-4)

Type of Establish- Ment	No. of Respon-dents	No. of Responses per Respondent	Total Annual Responses	Time for Response in Mins.	Total Annual Time in Hours
Ests./I-houses	6,800	20	136,000	60	136,000

The cost to the respondents is estimated at $4,670,000 annually. The Agency estimates that it will cost respondents $35 an hour in fulfilling these paperwork requirements. Respondents will spend an annual total of 136,000 hours and $4,670,000.

13. Capital, Start-up Cost, And Subsequent Maintenance

There are no capital or start-up costs related to this information collection activity.

14. Annual Cost To The Federal Government:

The cost to the Federal Government for this information collection is $700,000 annually. The Agency estimates a cost of $35 per hour for the time of its personnel.

15. Reasons For Changes In Burden:

There are no changes.

16. Tabulation, Analyses And Publication Plans:

There are no plans to publish the data for statistical use.

17. OMB Approval Number Display:

The form will display the OMB Control Number and date.

18. Exceptions To The Certification:

There are no exceptions to the certification. This information collection accords with the certification in item 19 of the OMB 83-I.

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