Document ID: FDA-2019-N-5971-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recommendations
To Reduce the Risk of Transfusion-Transmitted of Infection in Whole Blood and Blood Components; Agency Guidance
Posted Date: 2020-04-03T04:00Z

[Federal Register Volume 85, Number 65 (Friday, April 3, 2020)]
[Notices]
[Pages 18983-18984]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06986]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-5971]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Recommendations To 
Reduce the Risk of Transfusion-Transmitted of Infection in Whole Blood 
and Blood Components; Agency Guidance

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995 (PRA).

DATES: Submit written comments (including recommendations) on the 
collection of information by May 4, 2020.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0681. Also include the FDA docket 
number found in

[[Page 18984]]

brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Recommendations To Reduce the Risk of Transfusion-Transmitted Infection 
in Whole Blood and Blood Components; Agency Guidance

OMB Control Number 0910-0681--Extension

    Under Sec.  630.3(h) (21 CFR 630.3(h)), a list is set forth of 
relevant transfusion-transmitted infections (RTTIs) (Sec.  630.3(h)(1)) 
and the conditions under which a transfusion-transmitted infection 
(TTI) would meet the definition of an RTTI (Sec.  630.3(h)(2)). The 
list of RTTIs under Sec.  630.3(h)(1) includes, among other things, the 
following: Trypanosoma cruzi (Chagas), Creutzfeldt Jacob Disease (CJD)/
variant Creutzfeldt Jacob Disease (vCJD), plasmodium species (malaria), 
and West Nile virus. The RTTIs FDA has identified thus far under Sec.  
630.3(h)(2) include Zika virus and babesiosis. In addition, FDA has 
determined Ebola virus to be a TTI identified under Sec.  630.3(l). FDA 
has issued several guidance documents with recommendations regarding 
the RTTIs or TTIs including Chagas, babesiosis, Zika virus, West Nile 
virus, Ebola virus, malaria, CJD and vCJD, human immunodeficiency virus 
(HIV) and human T-lymphotropic virus, types I and II (HTLV).
    The Chagas, babesiosis, Zika virus, West Nile virus, and HTLV 
guidance documents provide recommendations for consignee and physician 
notification relating to donors that tested reactive for these 
infections.
    In addition, a blood establishment may receive information from a 
donor following collection that reveals the donor had a risk factor for 
an RTTI or TTI at the time of collection and should have been deferred 
for the risk factor. FDA has recommended, in the following guidance 
documents, that such a blood collection establishment notify the 
consignee regarding the distributed blood components that are 
potentially at-risk for an RTTI or TTI. In some cases, we recommend 
that if the blood was transfused, the consignee notify the transfusion 
recipient's physician of record regarding the potential risk. This 
recommendation is included in Ebola virus, malaria, CJD and vCJD, and 
HIV guidance documents. These guidance documents are available from our 
website at https://www.fda.gov/vaccines-blood-biologics/biologics-guidances/blood-guidances.
    In the Federal Register of January 7, 2020 (85 FR 716), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. For purposes of estimating burden under the 
PRA, we provided an estimate of one response and one burden hour 
annually. As we discussed in our 60-day notice, although such 
notifications are rare, we believe that these notification practices 
would be part of the usual and customary business practice for blood 
establishments and consignees in addressing the RTTIs or TTIs under the 
regulations. In addition, we believe respondents would have already 
developed standard operating procedures for notifying consignees and 
the recipient's physician of record regarding distributed blood 
components potentially at risk for a TTI. No comments were received in 
response to our 60-day notice, and we therefore retain this estimate. 
As other relevant transfusion-transmitted infections are determined 
under Sec.  630.3, we may continue to issue guidance accordingly, and, 
if approved, intend the information collections to be included under 
this OMB control number.
    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate. These guidance documents, as applicable, also refer to 
previously approved FDA collections of information. The collections of 
information in 21 CFR parts 601 and 640, and Form FDA 356h have been 
approved under OMB control number 0910-0338; the collections of 
information in 21 CFR parts 606 and 630 have been approved under OMB 
control number 0910-0116; the collections of information in 21 CFR 
606.171 have been approved under OMB control number 0910-0458.

    Dated: March 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-06986 Filed 4-2-20; 8:45 am]
BILLING CODE 4164-01-P