Notice2023-03515
Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice for Blood and Blood Components and Reducing the Risk of Transfusion-Transmitted Infections
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 21, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (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 on information collection associated with current good manufacturing practice (CGMP) for blood and blood components, including information collection recommendations found in Agency guidance related to reducing the risk of transfusion- transmitted infection (TTI).
Full Text
<html>
<head>
<title>Federal Register, Volume 88 Issue 34 (Tuesday, February 21, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 34 (Tuesday, February 21, 2023)]
[Notices]
[Pages 10515-10517]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-03515]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0343]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Current Good Manufacturing Practice for Blood and
Blood Components and Reducing the Risk of Transfusion-Transmitted
Infections
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (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 on information collection
associated with current good manufacturing practice (CGMP) for blood
and blood components, including information collection recommendations
found in Agency guidance related to reducing the risk of transfusion-
transmitted infection (TTI).
DATES: Either electronic or written comments on the collection of
information must be submitted by April 24, 2023.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 24, 2023. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2023-N-0343 for ``Current Good Manufacturing Practice for Blood and
Blood Components and Reducing the Risk of Transfusion-Transmitted
Infections.'' 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, 240-402-7500.
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,
<a href="/cdn-cgi/l/email-protection#a3f3f1e2f0d7c2c5c5e3c5c7c28dcbcbd08dc4ccd5"><span class="__cf_email__" data-cfemail="742426352700151212341210155a1c1c075a131b02">[email protected]</span></a>.
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
[[Page 10516]]
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.
Current Good Manufacturing Practice for Blood and Blood Components and
Reducing the Risk of Transfusion-Transmitted Infections
OMB Control Number 0910-0116--Revision
The FDA's Center for Biologics Evaluation and Research (CBER) is
responsible for regulatory oversight of the U.S. blood supply. FDA
issues and enforces requirements for blood collection and for the
manufacturing of blood products, including both blood components
intended for transfusion or for further manufacturing use. To implement
applicable statutory provisions, regulations have been codified at 21
CFR part 606--Current Good Manufacturing Practice for Blood and Blood
Components; 21 CFR part 610--General Biological Products Standards; 21
CFR part 630--Requirements for Blood and Blood Components Intended For
Transfusion or For Further Manufacturing Use; and 21 CFR part 640--
Additional Standards for Human Blood and Blood Products. The
regulations establish quality standard requirements applicable to blood
and blood products including information collection provisions.
CBER works closely with other parts of the Department of Health and
Human Services to identify and respond to potential threats to blood
safety and to monitor the availability of the blood supply. FDA has
progressively strengthened the overlapping safeguards that help to
ensure donor health and the safety of the blood supply for recipients
of blood and blood products. For example:
<bullet> Blood donors answer donor history questions to identify
risk factors that could indicate possible infection with a relevant-
transfusion transmitted infection.
<bullet> FDA requires blood establishments to maintain a record of
deferred donors to prevent collections ineligible donors.
<bullet> Blood donations are tested for several relevant
transfusion-transmitted infections, include HIV, hepatitis B virus, and
hepatitis C virus.
FDA also inspects blood establishments and monitors reports of
errors, accidents, and adverse events associated with blood donation or
transfusion.
Description of Respondents: Respondents to the collection of
information are establishments that collect blood and blood components
intended for transfusion or further manufacturing use.
For operational efficiency, we are revising the information
collection to account for burden that may be attributable to
recommendations found in associated FDA guidance documents, as listed
below. FDA regulations in Sec. 630.3(h) (21 CFR 630.3(h)) set forth a
list of relevant transfusion-transmitted infections (RTTIs) (Sec.
630.3(h)(1)) and the conditions under which a TTI would meet the
definition of an RTTI (Sec. 630.3(h)(2)). We have developed the
following guidance documents, consistent with our Good Guidance
Practice regulations in 21 CFR 10.115, that provide for comment at any
time. The guidance documents include recommendations specific to
certain RTTI or TTI regarding the collection of blood and blood
components and discuss corresponding recordkeeping and/or notification
activities.
Guidances Recommending Notification Based on Reactive Test Results
The following guidance documents provide recommendations for
consignee and physician notification relating to donations that test
reactive for RTTIs:
<bullet> Guidance for Industry: Use of Nucleic Acid Tests to Reduce
the Risk of Transmission of West Nile Virus from Donors of Whole Blood
and Blood Components Intended for Transfusion (November 2009);
<bullet> Use of Serological Tests to Reduce the Risk of
Transmission of Trypanosoma cruzi Infection in Blood and Blood
Components; Guidance for Industry (December 2017);
<bullet> Recommendations for Reducing the Risk of Transfusion-
Transmitted Babesiosis; Guidance for Industry (May 2019); and
<bullet> Use of Serological Tests to Reduce the Risk of
Transfusion-Transmitted Human T-Lymphotropic Virus Types I and II
(HTLV-I/II); Guidance for Industry (February 2020).
Guidances Recommending Notification Based on Post Donation Information
Regarding a Risk Factor
The following guidance documents provide recommendations for
consignee and physician notification under circumstances where a blood
establishment may receive information 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:
<bullet> Recommendations for Assessment of Blood Donor Eligibility,
Donor Deferral and Blood Product Management in Response to Ebola Virus;
Guidance for Industry (January 2017);
<bullet> Revised Recommendations for Reducing the Risk of Human
Immunodeficiency Virus Transmission by Blood and Blood Products--
Guidance for Industry (August 2020);
<bullet> Recommendations to Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob
Disease by Blood and Blood Components; Guidance for Industry (May
2022); and
<bullet> Recommendations to Reduce the Risk of Transfusion-
Transmitted Malaria; Guidance for Industry (December 2022).
These guidance documents are available for download from our
website at <a href="https://www.fda.gov/vaccines-blood-biologics/biologics-guidances/blood-guidances">https://www.fda.gov/vaccines-blood-biologics/biologics-guidances/blood-guidances</a>.
We believe such notifications are rare and 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. We also 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 RTTI or TTI. However, to account
for burden among respondents that may be attributable to this activity
we allot one response and 1 hour annually. As additional guidance is
developed by FDA addressing other RTTIs under Sec. 630.3(h)(2), we
will modify the information collection accordingly.
[[Page 10517]]
Dated: February 15, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-03515 Filed 2-17-23; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on February 21, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.