supportingstatementforALcontactupdatesheet2019

SUPPORTING STATEMENT JUSTIFICATION FOR

ACCREDITED LABORATORY PROGRAM ANNUAL CONTACT UPDATE

1. Circumstances Making Collection Of Information Necessary:

This is a request for a renewal of the information collection for the annual contact update for accredited laboratories related to meat, poultry, and egg products inspection.

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 ensuring that meat, poultry, and egg products are wholesome, not adulterated, and properly labeled and packaged.

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

FSIS uses the Annual Contact Update to maintain necessary information for responsibly connected personnel at the laboratories (see 9 CFR 439.20 (e) and 9 CFR 439.1 (w)). The completed Annual Contact Update form also informs the Agency if a laboratory, or responsibly connected person or entity, has been charged, indicted, or convicted or any crime listed in 9 CFR 439.52. If a laboratory, or responsibly connected person or entity, has been convicted of such a crime, FSIS will revoke the laboratory’s accreditation (9 CFR 439.53).

3. Use Of Improved Information Technology:

Under the Government Paperwork Elimination Act, FSIS is offering electronic versions of FSIS Form 10,000-11. Records may be maintained electronically provided that appropriate controls are implemented to ensure the integrity of the electronic data. The Agency estimates that 100% of the reporting will be done electronically.

4. Efforts To Identify Duplication:

No USDA agency, or any other Government agency, requires information regarding application for inspections, registration, exemptions, or accreditation of laboratories relating to meat, poultry, and egg products. There is no available 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. There are 60 small businesses.

6. Consequences If Information Were Collected Less Frequently:

To conduct the information collections less frequently will reduce the effectiveness of the meat and poultry 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 additional exceptions to the certification.

8. Consultation With Persons Outside The Agency:

In accordance with the Paperwork Reduction Act, FSIS published a 60-day notice in the Federal Register (84 FR 27077) on June 11, 2019, requesting comments regarding this information collection request. FSIS received no comments. FSIS also contacted three persons regarding the information collection: Stephanie Ellis, 314-982-2989; Roger Beers, 901-545-9421; and Dennis Mayeshiro, 562-928-0553 x 135, to request input on the FSIS burden estimates for the FSIS Form 10,000-11. The three individuals agreed that the FSIS burden estimate of 15 minutes to complete FSIS Form 10,000-11 was accurate.

9. Payment or Gifts to Respondents:

Respondents will not receive any 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 burden estimate for the reporting requirements associated with this information collection is 15 hours.

FSIS estimates that 60 respondents will spend 15 minutes completing this form once a year for a total of 60 responses and 15 hours.

ACCREDITED LABORATORY PROGRAM ANNUAL CONTACT UPDATE

(9 CFR 439.20 and 9 CFR 439.1/FSIS Form 10,000-11)

Type of Establishment	No. of Respondents	No. of Re- ponses per Respondent	Total Annual Responses	Time for Response in Mins.	Total Annual Time in Hours
Accredited Labs	60	1	60	15	15

The cost to the respondents is estimated at $680 annually. The Agency estimates that it will cost respondents $45.35, including fringe benefits, in fulfilling these paperwork requirements. Respondents will spend an annual total of 15 hours and $680. The hourly rate for the respondents was attained from the Department of Labor Bureau of Labor and Statistics wage data, May, 2018.

13. Capital and Start-up Cost and Subsequent Maintenance

There are no capital and start-up costs and subsequent maintenance burdens.

14. Annual Cost To Federal Government And Respondents:

The cost to the Federal Government for these information collection requirements is ­­­­$136.00 annually. The costs arise primarily from the review duties necessary to verify that laboratories comply with the information collection responsibilities. The Agency estimates a cost of $45.35 per hour, including fringe benefits, for Agency personnel time.

15. Reasons For Changes In Burden:

There are no changes in burden since the last approval.

16. Tabulation, Analyses And Publication Plans:

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

17. OMB Approval Number Display:

The OMB approval number will appear on required FSIS Forms.

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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