Revised Recommendations To Reduce the Risk of Transfusion-Transmitted Malaria; Guidance for Industry; Availability, 36598-36600 [2020-13066]
Download as PDF
<![CDATA[
36598
Federal Register / Vol. 85, No. 117 / Wednesday, June 17, 2020 / Notices
burden of this collection of information
of 1,500 hours was too low and that the
commenter believes more violations
occur than 1,500. The commenter
pointed to the number of Warning
Letters and Civil Money Penalties FDA
issued in 2019 to support this statement.
(Response) After reviewing the PTVR
submissions again over the past 5 years
we have made an adjustment to our
burden estimate. The number of
complaints submitted by the public is
not reflective of the total number of
reported violations of the FD&C Act and
implementing regulations. In 2019, FDA
received over 3,000 annual PTVR
complaint reports and issued over
14,600 Warning Letters, 4,700 Civil
Money Penalties, and 17 No-TobaccoSale-Orders. Reports of potential
violations from the public are critical in
helping FDA enforce tobacco
regulations to protect America’s youth.
The PTVR form was designed to provide
the public with a means of reporting
violations of the FD&C Act to the Center
for Tobacco Products. FDA conducts our
own investigations and inspections to
followup on complaints that may be
submitted through PTVR submissions.
FDA evaluates each report submitted to
determine if the activity is a potential
violation of the FD&C Act or related
regulations before deciding what
followup action, if any, is necessary.
FDA now estimates we will receive
5,370 reports annually.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity and Form FDA 3779
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden per response
Total hours
Reporting violations of the FD&C
Act, as amended by the Tobacco
Control Act via telephone, online
form, mail or email.
2,685
2
5,370
0.25 (15 minutes) .............................
1,343
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
khammond on DSKJM1Z7X2PROD with NOTICES
FDA estimates that submitting the
information (by telephone, online form,
mail or email) will take 0.25 hour (i.e.,
15 minutes) per response. This estimate
is based on the type and rate of
reporting that has been submitted
through the Potential Tobacco Violation
Report Form in the past.
FDA estimates the number of annual
respondents to this collection of
information will be 2,685, who will
each submit 2 reports by telephone,
online form, mail or email. Each report
is expected to take 0.25 hour to
complete and submit; therefore, total
burden hours for this collection of
information is estimated to be 1,343
hours (5,370 responses × 0.25 hour per
response).
We have adjusted our burden estimate
based on the updated number of reports
received to approximately 5,370 forms
annually, which more accurately
reflects the projected number of
submissions based on current trends.
Using these new figures, our estimated
burden for the information collection
signifies an overall increase to reflect
2,685 respondents per year and 1,343
hours.
Dated: June 5, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–13071 Filed 6–16–20; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
16:44 Jun 16, 2020
Jkt 250001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0601]
Mylan Institutional LLC et al.;
Withdrawal of Approval of 16
Abbreviated New Drug Applications;
Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register on March 9, 2020. The
document announced the withdrawal of
approval (as of April 8, 2020) of 16
abbreviated new drug applications
(ANDAs) from multiple applicants. The
document indicated that FDA was
withdrawing approval of the following
four ANDAs after receiving a
withdrawal request from Lupin
Pharmaceuticals, Inc., 111 South Calvert
St., Harborplace Tower, 21st Floor,
Baltimore, MD 21202: ANDA 065488,
Azithromycin Oral Suspension,
Equivalent to (EQ) 100 milligrams (mg)
base/5 milliliters (mL); EQ 200 mg base/
5 mL; ANDA 078410, Topiramate
Tablets, 25 mg, 50 mg, 100 mg, and 200
mg; ANDA 090441, Imipramine
Hydrochloride Tablets, 10 mg, 25 mg,
and 50 mg; and ANDA 200563,
Ciprofloxacin Oral Suspension, 250 mg/
5 mL and 500 mg/5 mL. Before FDA
withdrew the approval of these ANDAs,
Lupin Pharmaceuticals, Inc., informed
FDA that it did not want the approval
SUMMARY:
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
of the ANDAs withdrawn. Because
Lupin Pharmaceuticals, Inc., timely
requested that approval of these ANDAs
not be withdrawn, the approval of
ANDAs 065488, 078410, 090441, and
200563 is still in effect.
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676,
Silver Spring, MD 20993–0002, 240–
402–6980, Martha.Nguyen@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of Monday, March 9,
2020 (85 FR 13661), in FR Doc. 2020–
04691, the following correction is made:
On page 13661, in the table, the
entries for ANDAs 065488, 078410,
090441, and 200563 are removed.
Dated: June 12, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–13070 Filed 6–16–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2000–D–0187 (Formerly
Docket No. 2000D–1267)]
Revised Recommendations To Reduce
the Risk of Transfusion-Transmitted
Malaria; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
E:\FR\FM\17JNN1.SGM
17JNN1
Federal Register / Vol. 85, No. 117 / Wednesday, June 17, 2020 / Notices
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance entitled ‘‘Revised
Recommendations to Reduce the Risk of
Transfusion-Transmitted Malaria;
Guidance for Industry.’’ The revised
guidance provides blood establishments
that collect blood and blood
components with FDA’s
recommendations to reduce the risk of
transfusion-transmitted malaria. The
recommendations contained in this
guidance apply to the collection of
Whole Blood and blood components,
except Source Plasma. Blood
establishments are not required to assess
Source Plasma donors for malaria risk.
The guidance announced in this notice
supersedes the guidance entitled
‘‘Recommendations for Donor
Questioning, Deferral, Reentry, and
Product Management to Reduce the Risk
of Transfusion-Transmitted Malaria;
Guidance for Industry’’ dated August
2013 and updated August 2014.
DATES: The announcement of the
guidance is published in the Federal
Register on June 17, 2020. The Agency
is soliciting public comment, but is
implementing this guidance
immediately, because the Agency has
determined that prior public
participation is not feasible or
appropriate. Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
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.
VerDate Sep<11>2014
16:44 Jun 16, 2020
Jkt 250001
• 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–
2000–D–0187 for ‘‘Revised
Recommendations to Reduce the Risk of
Transfusion-Transmitted Malaria;
Guidance for Industry.’’ Received
comments 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
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
36599
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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the guidance to the Office of
Communication, Outreach and
Development, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist the office in processing your
requests. The guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 240–402–8010. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a final guidance entitled ‘‘Revised
Recommendations to Reduce the Risk of
Transfusion-Transmitted Malaria;
Guidance for Industry.’’ This document
was posted on FDA’s website on April
2, 2020 (see section III for electronic
access to the guidance). The revised
guidance document provides blood
establishments that collect blood and
blood components with FDA’s
recommendations to reduce the risk of
transfusion-transmitted malaria. The
recommendations contained in this
guidance apply to the collection of
Whole Blood and all blood components,
except Source Plasma. Blood
establishments are not required to assess
Source Plasma donors for malaria risk
(see 21 CFR 630.15(b)(8)).
The guidance revises the
recommendations in the August 2013
guidance, updated August 2014, by
reducing from 1 year to 3 months the
recommended deferral period for certain
E:\FR\FM\17JNN1.SGM
17JNN1
khammond on DSKJM1Z7X2PROD with NOTICES
36600
Federal Register / Vol. 85, No. 117 / Wednesday, June 17, 2020 / Notices
blood donors who are residents of a
non-endemic country and who travel to
malaria-endemic areas. In addition, the
guidance provides notice of an
alternative procedure to permit the
collection of blood and blood
components from such donors without
a deferral period, provided the blood
components are pathogen-reduced using
an FDA-approved pathogen reduction
device, effective against Plasmodium
falciparum, according to manufacturer’s
instructions for use. The revised
recommendations are based on the
current epidemiological data on malaria,
the risk of transfusion-transmitted
malaria and the availability of FDAapproved devices. FDA expects
implementation of these revised
recommendations will not be associated
with any adverse effect on the safety of
the blood supply. Furthermore, early
implementation of the
recommendations in this guidance may
help to address significant blood
shortages that are occurring as a result
of a current and ongoing Coronavirus
Disease 2019 (COVID–19) public health
emergency.
The guidance announced in this
notice supersedes the guidance entitled
‘‘Recommendations for Donor
Questioning, Deferral, Reentry, and
Product Management to Reduce the Risk
of Transfusion-Transmitted Malaria;
Guidance for Industry’’ dated August
2013 and updated August 2014.
In light of the COVID–19 public
health emergency, FDA is issuing this
guidance for immediate implementation
in accordance with § 10.115(g)(3)
without initially seeking prior comment
because the Agency has determined that
prior public participation is not feasible
or appropriate (see § 10.115(g)(2) and
section 701(h)(1)(C)(i) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
371(h)(1)(C)(i))). FDA expects that the
revised recommendations will increase
the availability of blood and blood
components while maintaining the
safety of blood and blood components.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (§ 10.115(g)(2)). The
guidance represents the current thinking
of FDA on ’’Revised Recommendations
to Reduce the Risk of TransfusionTransmitted Malaria.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
VerDate Sep<11>2014
16:44 Jun 16, 2020
Jkt 250001
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3521). The collections of information in
21 CFR part 601 and Form FDA 356h
have been approved under OMB control
number 0910–0338; 21 CFR parts 606
and 630 have been approved under
OMB control number 0910–0116; and
the collections of information for
consignee and transfusion recipient
physician notification have been
approved under OMB control number
0910–0681.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics/
biologics-guidances, https://
www.fda.gov/emergency-preparednessand-response/mcm-issues/covid-19related-guidance-documents-industryfda-staff-and-other-stakeholders, or
https://www.regulations.gov.
Dated: June 12, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–13066 Filed 6–16–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–1893]
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry, FDA staff, and
other stakeholders entitled ‘‘PatientFocused Drug Development: Collecting
Comprehensive and Representative
Input.’’ This guidance is the first of a
series of four methodological guidance
documents that FDA committed to
develop to address in a stepwise manner
how to collect and submit information
from patients and caregivers for medical
product development and regulatory
decision making. This guidance
finalizes the draft guidance of the same
title issued on June 13, 2018.
SUMMARY:
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
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
Patient-Focused Drug Development:
Collecting Comprehensive and
Representative Input; Guidance for
Industry, Food and Drug
Administration Staff, and Other
Stakeholders; Availability
AGENCY:
The announcement of the
guidance is published in the Federal
Register on June 17, 2020.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
DATES:
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–
2018–D–1893 for ‘‘Patient-Focused Drug
Development: Collecting
Comprehensive and Representative
Input.’’ Received comments 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.
E:\FR\FM\17JNN1.SGM
17JNN1
]]>Agencies
[Federal Register Volume 85, Number 117 (Wednesday, June 17, 2020)]
[Notices]
[Pages 36598-36600]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13066]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2000-D-0187 (Formerly Docket No. 2000D-1267)]
Revised Recommendations To Reduce the Risk of Transfusion-
Transmitted Malaria; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
[[Page 36599]]
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Revised Recommendations
to Reduce the Risk of Transfusion-Transmitted Malaria; Guidance for
Industry.'' The revised guidance provides blood establishments that
collect blood and blood components with FDA's recommendations to reduce
the risk of transfusion-transmitted malaria. The recommendations
contained in this guidance apply to the collection of Whole Blood and
blood components, except Source Plasma. Blood establishments are not
required to assess Source Plasma donors for malaria risk. The guidance
announced in this notice supersedes the guidance entitled
``Recommendations for Donor Questioning, Deferral, Reentry, and Product
Management to Reduce the Risk of Transfusion-Transmitted Malaria;
Guidance for Industry'' dated August 2013 and updated August 2014.
DATES: The announcement of the guidance is published in the Federal
Register on June 17, 2020. The Agency is soliciting public comment, but
is implementing this guidance immediately, because the Agency has
determined that prior public participation is not feasible or
appropriate. Submit either electronic or written comments on Agency
guidances at any time.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
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-2000-D-0187 for ``Revised Recommendations to Reduce the Risk of
Transfusion-Transmitted Malaria; Guidance for Industry.'' Received
comments 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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the guidance to the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist the office in processing
your requests. The guidance may also be obtained by mail by calling
CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Stephen Ripley, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a final guidance entitled
``Revised Recommendations to Reduce the Risk of Transfusion-Transmitted
Malaria; Guidance for Industry.'' This document was posted on FDA's
website on April 2, 2020 (see section III for electronic access to the
guidance). The revised guidance document provides blood establishments
that collect blood and blood components with FDA's recommendations to
reduce the risk of transfusion-transmitted malaria. The recommendations
contained in this guidance apply to the collection of Whole Blood and
all blood components, except Source Plasma. Blood establishments are
not required to assess Source Plasma donors for malaria risk (see 21
CFR 630.15(b)(8)).
The guidance revises the recommendations in the August 2013
guidance, updated August 2014, by reducing from 1 year to 3 months the
recommended deferral period for certain
[[Page 36600]]
blood donors who are residents of a non-endemic country and who travel
to malaria-endemic areas. In addition, the guidance provides notice of
an alternative procedure to permit the collection of blood and blood
components from such donors without a deferral period, provided the
blood components are pathogen-reduced using an FDA-approved pathogen
reduction device, effective against Plasmodium falciparum, according to
manufacturer's instructions for use. The revised recommendations are
based on the current epidemiological data on malaria, the risk of
transfusion-transmitted malaria and the availability of FDA-approved
devices. FDA expects implementation of these revised recommendations
will not be associated with any adverse effect on the safety of the
blood supply. Furthermore, early implementation of the recommendations
in this guidance may help to address significant blood shortages that
are occurring as a result of a current and ongoing Coronavirus Disease
2019 (COVID-19) public health emergency.
The guidance announced in this notice supersedes the guidance
entitled ``Recommendations for Donor Questioning, Deferral, Reentry,
and Product Management to Reduce the Risk of Transfusion-Transmitted
Malaria; Guidance for Industry'' dated August 2013 and updated August
2014.
In light of the COVID-19 public health emergency, FDA is issuing
this guidance for immediate implementation in accordance with Sec.
10.115(g)(3) without initially seeking prior comment because the Agency
has determined that prior public participation is not feasible or
appropriate (see Sec. 10.115(g)(2) and section 701(h)(1)(C)(i) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(h)(1)(C)(i))). FDA
expects that the revised recommendations will increase the availability
of blood and blood components while maintaining the safety of blood and
blood components.
This guidance is being issued consistent with FDA's good guidance
practices regulation (Sec. 10.115(g)(2)). The guidance represents the
current thinking of FDA on ''Revised Recommendations to Reduce the Risk
of Transfusion-Transmitted Malaria.'' It does not establish any rights
for any person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.
II. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The
collections of information in 21 CFR part 601 and Form FDA 356h have
been approved under OMB control number 0910-0338; 21 CFR parts 606 and
630 have been approved under OMB control number 0910-0116; and the
collections of information for consignee and transfusion recipient
physician notification have been approved under OMB control number
0910-0681.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances,
https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders, or https://www.regulations.gov.
Dated: June 12, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-13066 Filed 6-16-20; 8:45 am]
BILLING CODE 4164-01-P
