Document ID: FDA-2019-N-5971-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Recommendations To Reduce the Risk of Transfusion Transmitted of Infection in Whole Blood and Blood Components; Agency
Guidance
Posted Date: 2020-01-07T05:00Z

[Federal Register Volume 85, Number 4 (Tuesday, January 7, 2020)]
[Notices]
[Pages 716-718]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00034]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Proposed Collection; 
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.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments concerning establishment 
notification of a consignee and consignee notification of a recipient's 
physician of record regarding a possible increased risk of transfusion-
transmitted infection.

DATES: Submit either electronic or written comments on the collection 
of information by March 9, 2020.

ADDRESSES: You may submit comments as follows. Please note that late 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before March 9, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of March 9, 2020. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically,

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including attachments, to https://www.regulations.gov will be posted to 
the docket unchanged. Because your comment will be made public, you are 
solely responsible for ensuring that your comment does not include any 
confidential information that you or a third party may not wish to be 
posted, such as medical information, your or anyone else's Social 
Security number, or confidential business information, such as a 
manufacturing process. Please note that if you include your name, 
contact information, or other information that identifies you in the 
body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2019-N-5971 for ``Use of Serological Tests to Reduce the Risk of 
the Transfusion-Transmitted Infection in Whole Blood and Blood 
Components; Agency Guidance.'' Received comments, those filed in a 
timely manner (see ADDRESSES) will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at https://www.regulations.gov or at the Dockets Management Staff 
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

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: Under the PRA (44 U.S.C. 3501-3521), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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 and 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 
a 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 a RTTI or TTI. In some cases,

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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.
    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. 
Therefore, for the purpose of estimating burden under the PRA, we 
provide an estimate of one response and one burden hour annually.
    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 
estimates. These guidance documents, as applicable, also refer to 
previously approved collections of information found in FDA 
regulations. 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: December 31, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-00034 Filed 1-6-20; 8:45 am]
 BILLING CODE 4164-01-P