Notice2023-15458
Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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
July 21, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) 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.
Full Text
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<title>Federal Register, Volume 88 Issue 139 (Friday, July 21, 2023)</title>
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[Federal Register Volume 88, Number 139 (Friday, July 21, 2023)]
[Notices]
[Pages 47149-47151]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-15458]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0343]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) 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.
DATES: Submit written comments (including recommendations) on the
collection of information by August 21, 2023.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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 0910-0116. Also include the FDA docket
number found in 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,
<a href="/cdn-cgi/l/email-protection#07575546547366616147616366296f6f7429606871"><span class="__cf_email__" data-cfemail="8ededccfddfaefe8e8cee8eaefa0e6e6fda0e9e1f8">[email protected]</span></a>.
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.
[[Page 47150]]
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 are 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 medical 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 from ineligible donors.
<bullet> Blood donations are tested for several relevant
transfusion-transmitted infections, including 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 licensed and registered-only 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, and currently approved in OMB control number 0910-0681. 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 developed Agency guidance documents,
consistent with our good guidance practice regulations in 21 CFR
10.115, that provide for comment at any time. These 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. The 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>.
A. 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 an RTTI:
<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).
B. Guidances Recommending Notification Based on Post Donation
Information Regarding a Risk Factor or History of an RTTI or TTI
The following guidance documents provide recommendations for
consignee and, in some instances, physician notification under
circumstances where a blood establishment may receive information
following collection that reveals the donor had a history of or risk
factor for an 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> 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).
In the Federal Register of February 21, 2023 (88 FR 10515), we
published a 60-day notice requesting public comment on the proposed
collection of information. Although one comment was received, it was
not responsive to the four information collection topics solicited. On
our own initiative we have since revised the information collection to
reflect recent finalization of the guidance document entitled
``Recommendations for Evaluating Donor Eligibility Using Individual
Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus
Transmission by Blood and Blood Products,'' announced in the Federal
Register of May 12, 2023 (88 FR 30765). The recommendations included in
the guidance document will potentially expand the number of people
eligible to donate blood, while also maintaining the appropriate
safeguards to protect the safety of the blood supply.
We believe the notifications discussed in the respective guidance
documents 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 an RTTI or TTI. However, to account for burden among
respondents that may be attributable to the notification 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 47151]]
Dated: July 17, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-15458 Filed 7-20-23; 8:45 am]
BILLING CODE 4164-01-P
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