Supporting Statement Final 3-19-14

Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion

0910-0681

SUPPORTING STATEMENT

Terms of Clearance: None.

1. Justification

1. Circumstances Making the Collection of Information Necessary

The Food and Drug Administration (FDA) is requesting an extension of Office of Management and Budget (OMB) Control No. 0910-0681, and OMB approval of the information collection provisions contained in the above-referenced guidance document. The information collection provisions are listed below:

Consignees notification	Disclosure	Recommends that establishments notify consignees of all previously distributed blood and blood components that tested repeatedly reactive for the Trypanosoma cruzi (T. Cruzi) antibody.
Consignees to notify the recipient’s physician of record	Disclosure	Recommends consignees to notify the recipient’s physician of record of a possible increased risk of Trypanosoma cruzi infection, if the recipient was transfused with a blood or blood components from a donor who tested repeatedly reactive for Trypanosoma cruzi antibody.

The guidance document implements the donor screening recommendations for the FDA approved serological test systems for the detection of antibodies to T. cruzi. The use of the donor screening tests are to reduce the risk of transmission of T. cruzi infection by detecting antibodies to T. cruzi in plasma and serum samples from individual human donors, including donors of Whole Blood and blood components intended for transfusion. The guidance recommends that establishments that manufacture whole blood and blood components intended for transfusion should notify consignees of all previously collected in-date blood and blood components to quarantine and return the blood and blood components to establishments or to destroy them within 3 calendar days after a donor tests repeatedly reactive by a licensed test for T. cruzi antibody. When establishments identify a donor who is repeatedly reactive by a licensed test for T. cruzi antibodies and for whom there is additional information indicating risk of T. cruzi infection, such as testing positive on a licensed supplemental test (when such test is available) or until such test is available, information that the donor or donor’s mother resided in an area endemic for Chagas disease (Mexico, Central and South America) or as a result of other medical diagnostic testing of the donor indicating T. cruzi infection, FDA recommends that the establishment notify consignees of all previously distributed blood and blood components collected during the “lookback” period and, if blood or blood components were transfused, to encourage consignees to notify the recipient’s physician of record of a possible increased risk of T. cruzi infection.

2. Purpose and Use of the Information Collection

The notification of consignees and of the recipient’s physician of record is intended to provide the necessary information regarding possible increased risk of T. cruzi infection. All donors who test repeatedly reactive should be counseled to seek a physician’s advice. It also may be helpful to refer them to their state and local health departments or to other appropriate community resources.

3. Use of Improved Information Technology and Burden Reduction

Notification of consignees or the recipient’s physician of record can be accomplished by email, phone, fax, or mail. FDA is not aware of any improved technology to reduce the burden.

4. Efforts to Identify Duplication and Use of Similar Information

FDA is the only agency that recommends this collection of information. There is no similar information available from any other source.

5. Impact on Small Businesses or Other Small Entities

This collection of information applies to small as well as large establishments. Although FDA must apply the statutory and regulatory requirements equally among all enterprises, FDA does provide special help to small businesses. The Center for Biologics Evaluation and Research, Office of Communication, Outreach and Development, Division of Manufacturers Assistance and Training, provides assistance to small businesses subject to FDA’s regulatory requirements.

6. Consequences of Collecting the Information Less Frequently

Less frequent collection of information would not provide the necessary information needed to help ensure the safety of the nation’s blood supply.

There are no legal obstacles to reduce the burden.

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

There are no special circumstances for this collection of information.

8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency

In accordance with 5 CFR 1320.8(d), FDA published a 60-day notice for public comment in the FEDERAL REGISTER of August 2, 2013 (78 FR 46954). No comments were received from the public.

9. Explanation of Any Payment or Gift to Respondents

No payment or gift was provided to respondents.

10. Assurance of Confidentiality Provided to Respondents

The confidentiality of information received by FDA would be consistent with the Freedom of Information Act (FOIA) and FDA’s published regulations of “Public Information” under 21 CFR Part 20. Inspectors may copy records as part of an inspection of a blood establishment. This information is for internal use and may be subject to, in whole or in part, FOIA and applicable FDA regulations.

11. Justification for Sensitive Questions

Questions of a sensitive nature are not applicable to this information collection.

12. Estimates of Annualized Burden Hours and Costs

12a. Annualized Hour Burden Estimate

Respondents to this collection of information are establishments that manufacture Whole Blood and blood components intended for transfusion. FDA believes that the information collection provisions mentioned in the guidance document for establishments to notify consignees and for the consignees to notify the blood and blood component recipient’s physician of record do not create a new burden for the respondents. FDA believes that the provisions recommended in the guidance are part of the usual and customary business practice. Since the end of January 2007, a number of blood centers representing a large proportion of U.S. blood collections have been testing donors using a licensed assay. FDA believes these establishments have already developed standard operating procedures when a donor is repeatedly reactive by a licensed test for T. cruzi antibodies and for whom there is additional information indicating risk of T. cruzi infection for notifying consignees and for the consignees to notify the recipient's physician of record of possible increased risk of T. cruzi infection.

The guidance also refers to previously approved collections of information found in FDA regulations. The collections of information in 21 CFR 601.12 have been approved under OMB control no. 0910-0338; the collections of information in 21 CFR 606.100, 606.121, 606.122, 606.160(b)(ix), 606.170(b), 610.40, and 630.6 have been approved under OMB control no. 0910-0116; the collections of information in 21 CFR 606.171 have been approved under OMB control no. 0910-0458.

There is no annual hour burden estimate associated with this collection of information.

12b. Annualized Cost Burden Estimate

There is no estimated annual cost burden associated with this collection of information.

13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs

There are no capital, start-up, operating or maintenance costs associated with this information collection.

14. Annualized Cost to the Federal Government

There are no estimated annual costs to the Federal Government associated with this collection of information.

15. Explanation for Program Changes or Adjustments

There are no program changes or adjustments from the previous burden estimate. The collections of information in the guidance document are part of usual and customary business practices.

16. Plans for Tabulation and Publication and Project Time Schedule

There are no tabulated results to publish for this information collection.

17. Reason(s) Display of OMB Expiration Date is Inappropriate

FDA is not seeking approval to exempt display of the expiration date of OMB approval.

18. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.

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