supportingstatement permit to obtain specimens of condemned or other inedible materials 2019

SUPPORTING STATEMENT JUSTIFICATION FOR

PERMIT TO OBTAIN SPECIMENS OF CONDEMNED OR

OTHER INEDIBLE MATERIALS FROM OFFICAL ESTABLISHMENTS

1. Circumstances Making Collection Of Information Necessary:

This is a request for a new information collection for permits for applicants that want to obtain specimens of condemned or other inedible materials from official establishments.

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.

FSIS requires any person desiring specimens of condemned or other inedible materials, including embryos and specimens of animal parasites, to file a written application on the FSIS Form 6700–2, ‘‘Application and Permit to Obtain Specimens from Official Establishments,’’ as provided in 9 CFR 314.9(a). The applicant must indicate the purpose for the specimens and arrange with and receive permission from the official establishment to obtain the specimens.

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

Under the regulations, official establishments may release specimens for educational, research or other nonfood purposes under the permit issued by the inspector in charge. The applicant agrees that the collection and handling of the specimens will be at such time and place and in such a manner as not to interfere with inspection or to cause any objectionable condition.

3. Use Of Improved Information Technology:

Under the Government Paperwork Elimination Act, FSIS is offering an electronic version of FSIS Form 6700-2. 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 paperwork will be done electronically.

4. Efforts To Identify Duplication:

No USDA agency, or any other Government agency, requires information from applicants that want to obtain specimens of condemned or other inedible materials from official establishments. 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. This information collection will affect approximately 60 small entities.

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 27076) on June 11, 2019, requesting comments regarding this information collection request. FSIS received no comments. FSIS also contacted several outside individuals, Tom Hart (319-236-9327); Gwen Timmerman (319-236-9355); Keith Arnold (415-663-8997 ext 119) and Ginger Kennicker (319-236-9367), to request input on the FSIS burden estimates for the FSIS Form 6700-2. The outside individuals agreed that the FSIS burden estimate of 10 minutes to complete FSIS Form 6700-2 was accurate. Based on input from the commenters, the Agency is making no changes to the estimated burden for completion of the form.

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 274 hours.

FSIS estimates that 1,642 respondents will spend 10 minutes completing this form once a year for a total of 1,642 responses and 274 hours.

PERMIT TO OBTAIN SPECIMENS FROM OFFICIAL ESTABLISHMENTS

(9 CFR 314.9(a)/FSIS Form 6700-2)

Type of Respondent	No. of Respondents	No. of Re- ponses per Respondent	Total Annual Responses	Time for Response in Mins.	Total Annual Time in Hours
Official Establishments	1,642	1	1,642	10	274

The cost to the respondents is estimated at $12,426 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 274 hours and $12,426. 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 ­­­­$6,213.00 annually. The costs arise primarily from the duties necessary to review applications and issue permits. The Agency estimates a cost of $45.35 per hour, including fringe benefits, for Agency personnel time.

15. Reasons For Changes In Burden:

FSIS was collecting application information for permits without approval and is claiming this as a violation. The collection has 1,642 respondents, 1,642 responses and 274 burden hours.

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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