[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,
[email protected].
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