[Federal Register Volume 85, Number 117 (Wednesday, June 17, 2020)]
[Notices]
[Pages 36595-36597]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13051]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-1211]


Revised Recommendations for Reducing the Risk of Human 
Immunodeficiency Virus Transmission by Blood and Blood Products; 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance entitled ``Revised Recommendations 
for Reducing the Risk of Human Immunodeficiency Virus Transmission by 
Blood and Blood Products; Guidance for Industry.'' The revised guidance 
provides blood establishments that collect blood or blood components, 
including Source Plasma, with FDA's revised donor deferral 
recommendations for individuals with increased risk for transmitting 
human immunodeficiency virus (HIV) infection. FDA is also recommending 
that these blood establishments make corresponding revisions to their 
donor educational materials, donor history questionnaires, and 
accompanying materials, along with revisions to donor requalification 
and product management procedures. The guidance also incorporates 
certain other recommendations related to donor educational materials. 
The guidance announced in this notice supersedes the guidance of the 
same title dated December 2015.

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://

[[Page 36596]]

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-2015-D-1211 for ``Revised Recommendations for Reducing the Risk of 
Human Immunodeficiency Virus Transmission by Blood and Blood Products; 
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 (Sec.  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 document entitled ``Revised 
Recommendations for Reducing the Risk of Human Immunodeficiency Virus 
Transmission by Blood and Blood Products; 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 provides 
blood establishments that collect blood or blood components, including 
Source Plasma, with FDA's revised donor deferral recommendations for 
individuals with increased risk for transmitting HIV infection. FDA is 
also recommending that these blood establishments make corresponding 
revisions to their donor educational materials, donor history 
questionnaires, and accompanying materials, along with revisions to 
donor requalification and product management procedures. The guidance 
also incorporates certain other recommendations related to donor 
educational materials. FDA expects implementation of these revised 
recommendations will not be associated with any adverse effect on the 
safety of the blood supply. Furthermore, 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 of the same 
title dated December 2015.
    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 for Reducing the 
Risk of Human Immunodeficiency Virus Transmission by Blood and Blood 
Products.'' 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-

[[Page 36597]]

3520). The collections of information in 21 CFR part 601 have been 
approved under OMB control number 0910-0338; the collections of 
information in 21 CFR parts 610, 630, and 640 have been approved under 
OMB control number 0910-0116; and the collections of information for 
consignee 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. 2020-13051 Filed 6-16-20; 8:45 am]
BILLING CODE 4164-01-P


