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, 10515-10517 [2023-03515]
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Federal Register / Vol. 88, No. 34 / Tuesday, February 21, 2023 / Notices
2023 funds, subject to the availability of
funds. Funding amounts for years 2–5
will be set at continuation.
Authority: This program is authorized
under Section 307 of the PHS Act (42
U.S.C 242); section 317(k)(1) and (2) of
the PHS Act (42 U.S.C. 247b(k)(1) and
(2).
Period of Performance: 7/1/2023
through 6/30/2028.
Dated: February 15, 2023.
Terrance Perry,
Chief Grants Management Officer, Centers for
Disease Control and Prevention.
[FR Doc. 2023–03522 Filed 2–17–23; 8:45 am]
BILLING CODE 4163–18–P
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.
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 https://
www.regulations.gov electronic filing
system will accept comments until
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:54 Feb 17, 2023
Jkt 259001
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:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
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–
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 https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday, 240–402–7500.
PO 00000
Frm 00021
Fmt 4703
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10515
• 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-201509-18/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, 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, 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
E:\FR\FM\21FEN1.SGM
21FEN1
10516
Federal Register / Vol. 88, No. 34 / Tuesday, February 21, 2023 / Notices
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.
lotter on DSK11XQN23PROD with NOTICES1
Current Good Manufacturing Practice
for Blood and Blood Components and
Reducing the Risk of TransfusionTransmitted 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
VerDate Sep<11>2014
17:54 Feb 17, 2023
Jkt 259001
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:
• Blood donors answer donor history
questions to identify risk factors that
could indicate possible infection with a
relevant-transfusion transmitted
infection.
• FDA requires blood establishments
to maintain a record of deferred donors
to prevent collections ineligible donors.
• 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
§ 630.3(h) (21 CFR 630.3(h)) set forth a
list of relevant transfusion-transmitted
infections (RTTIs) (§ 630.3(h)(1)) and the
conditions under which a TTI would
meet the definition of an RTTI
(§ 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:
• 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);
• Use of Serological Tests to Reduce
the Risk of Transmission of
Trypanosoma cruzi Infection in Blood
and Blood Components; Guidance for
Industry (December 2017);
PO 00000
Frm 00022
Fmt 4703
Sfmt 4703
• Recommendations for Reducing the
Risk of Transfusion-Transmitted
Babesiosis; Guidance for Industry (May
2019); and
• 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:
• Recommendations for Assessment
of Blood Donor Eligibility, Donor
Deferral and Blood Product
Management in Response to Ebola
Virus; Guidance for Industry (January
2017);
• Revised Recommendations for
Reducing the Risk of Human
Immunodeficiency Virus Transmission
by Blood and Blood Products—
Guidance for Industry (August 2020);
• 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
• 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 https://www.fda.gov/vaccines-bloodbiologics/biologics-guidances/bloodguidances.
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 § 630.3(h)(2), we will
modify the information collection
accordingly.
E:\FR\FM\21FEN1.SGM
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Federal Register / Vol. 88, No. 34 / Tuesday, February 21, 2023 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0804]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Premarket
Notification Procedures
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 medical
device premarket notification (510(k)).
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 https://
www.regulations.gov 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.
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
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,
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
VerDate Sep<11>2014
17:54 Feb 17, 2023
Jkt 259001
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–
2013–N–0804 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Premarket Notification Procedures.’’
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, 240–402–7500.
• 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
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
10517
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-201509-18/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, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, 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
E:\FR\FM\21FEN1.SGM
21FEN1
]]>Agencies
[Federal Register Volume 88, Number 34 (Tuesday, February 21, 2023)]
[Notices]
[Pages 10515-10517]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov 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:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, 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-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 https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
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, 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,
[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
[[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:
Blood donors answer donor history questions to identify
risk factors that could indicate possible infection with a relevant-
transfusion transmitted infection.
FDA requires blood establishments to maintain a record of
deferred donors to prevent collections ineligible donors.
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:
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);
Use of Serological Tests to Reduce the Risk of
Transmission of Trypanosoma cruzi Infection in Blood and Blood
Components; Guidance for Industry (December 2017);
Recommendations for Reducing the Risk of Transfusion-
Transmitted Babesiosis; Guidance for Industry (May 2019); and
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:
Recommendations for Assessment of Blood Donor Eligibility,
Donor Deferral and Blood Product Management in Response to Ebola Virus;
Guidance for Industry (January 2017);
Revised Recommendations for Reducing the Risk of Human
Immunodeficiency Virus Transmission by Blood and Blood Products--
Guidance for Industry (August 2020);
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
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 https://www.fda.gov/vaccines-blood-biologics/biologics-guidances/blood-guidances.
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
