Recommendations To Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt Jakob Disease by Blood and Blood Components; Draft Guidance for Industry; Availability, 5668-5670 [2020-01815]

Download as PDF 5668 Federal Register / Vol. 85, No. 21 / Friday, January 31, 2020 / Notices technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and (e) Assess information collection costs. To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639–7570 or send an email to omb@cdc.gov. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395–5806. Provide written comments within 30 days of notice publication. Proposed Project Data Collection for CDC Fellowship Programs (OMB Control No. 0920–1163, Exp. 2/29/2020)—Extension—Division of Scientific Education and Professional Development (DSEPD), Center for Surveillance, Epidemiology, and Laboratory Services (CSELS), Centers for Disease Control and Prevention (CDC). Background and Brief Description CDC’s mission is to protect America from health, safety, and security threats, both foreign and in the U.S. To ensure a competent, sustainable, and empowered public health workforce prepared to meet these challenges, CDC plays a key role in developing, implementing, and managing a number of fellowship programs. A fellowship is defined as a training or work experience lasting at least one month and consisting of primarily experiential (i.e., on-the-job) learning, in which the trainee has a designated mentor or supervisor. CDC fellowships are intended to develop public health professionals, enhance the public health workforce, and strengthen collaborations with partners in public health and healthcare organizations, academia, and other stakeholders in governmental and non-governmental organizations. Assessing fellowship activities is essential to ensure that the public health workforce is equipped to promote and protect the public’s health. CDC requests a three-year extension of a generic clearance to collect data about its fellowship programs, as they relate to public health workforce development. Data collections will allow for ongoing, collaborative, and actionable communications between CDC fellowship programs and stakeholders (e.g., fellows, supervisors/mentors, alumni). These collections might include short surveys, interviews, and focus groups. Intended use of the resulting information is to • inform planning, implementation, and continuous quality improvement of fellowship activities and services; • improve efficiencies in the delivery of fellowship activities and services; and • determine to what extent fellowship activities and services are achieving established goals. Collection and use of information about CDC fellowship activities will help ensure effective, efficient, and satisfying experiences among fellowship program participants and stakeholders. CDC estimates that annually, a given fellowship program will conduct one query each with one of the three respondent groups: Fellowship applicants or fellows; mentors, supervisors, or employers; and alumni. The total annualized burden hours of 2,957 was determined as depicted in the following table. OMB approval is requested for three years. There are no costs to respondents other than their time. ESTIMATED ANNUALIZED BURDEN HOURS Form name Applicants or fellows ....................................... Mentors, supervisors, or employers ............... Alumni ............................................................. Fellowship Data Collection Instrument ........... Fellowship Data Collection Instrument ........... Fellowship Data Collection Instrument ........... Jeffery M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention. [FR Doc. 2020–01860 Filed 1–30–20; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–D–0307] jbell on DSKJLSW7X2PROD with NOTICES Number of respondents Type of respondents Recommendations To Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt Jakob Disease by Blood and Blood Components; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. VerDate Sep<11>2014 17:16 Jan 30, 2020 Jkt 250001 The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ‘‘Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt Jakob Disease by Blood and Blood Components.’’ The draft guidance provides blood establishments that collect blood and blood components with revised recommendations intended to reduce the possible risk of transmission of Creutzfeldt-Jakob disease (CJD) and variant CreutzfeldtJakob disease (vCJD) by blood and blood components. The recommendations in the draft guidance apply to the collection of Whole Blood and blood components intended for transfusion or for use in further manufacturing, including Source Plasma. The draft guidance replaces the document entitled ‘‘Amendment to ‘Revised Preventive SUMMARY: PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 1,848 370 3,696 Number of responses per respondent 1 1 1 Average burden per response (in hours) 30/60 30/60 30/60 Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products,’ ’’ Draft Guidance for Industry, dated December 2017, and when finalized, will supersede the document entitled ‘‘Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products, Guidance for Industry,’’ dated May 2010 and updated January 2016. Submit either electronic or written comments on the draft guidance by March 31, 2020 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. DATES: You may submit comments on any guidance at any time as follows: ADDRESSES: E:\FR\FM\31JAN1.SGM 31JAN1 Federal Register / Vol. 85, No. 21 / Friday, January 31, 2020 / 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. • 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’’). jbell on DSKJLSW7X2PROD with NOTICES 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– 2012–D–0307 for ‘‘Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt Jakob Disease by Blood and Blood Components.’’ 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. • 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 VerDate Sep<11>2014 17:16 Jan 30, 2020 Jkt 250001 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. 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 draft 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 draft 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 draft guidance document. FOR FURTHER INFORMATION CONTACT: Sana F. Hussain, 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: PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 5669 I. Background FDA is announcing the availability of a draft guidance entitled ‘‘Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt Jakob Disease by Blood and Blood Components.’’ The draft guidance provides blood establishments that collect blood and blood components with revised recommendations intended to reduce the possible risk of transmission of CJD and vCJD by blood and blood components. The recommendations in the draft guidance apply to the collection of Whole Blood and blood components intended for transfusion or for use in further manufacturing, including Source Plasma. FDA is revising or removing our current recommendations to screen blood donors for: (1) Geographic risk of possible exposure to bovine spongiform encephalopathy, including time spent on U.S. military bases in Europe; (2) receipt of a blood transfusion in certain vCJD risk countries; (3) risk factors for iatrogenic CJD (i.e., a history of taking human cadaveric pituitary-derived growth hormone; (4) having blood relatives with CJD; and (5) a history of injecting bovine insulin. In the Federal Register of December 22, 2017 (82 FR 60747), FDA announced the availability of the draft document entitled ‘‘Amendment to ‘Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products’ ’’ dated December 2017 (December 2017 draft guidance). FDA received several comments on the December 2017 draft guidance. Based on those comments, FDA is announcing a revised draft guidance. The draft guidance announced in this notice replaces the December 2017 draft guidance, and, when finalized, will supersede the document entitled ‘‘Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products, Guidance for Industry,’’ dated May 2010 and updated January 2016. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on recommendations to reduce the possible risk of transmission of CJD and vCJD by blood and blood components. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative E:\FR\FM\31JAN1.SGM 31JAN1 5670 Federal Register / Vol. 85, No. 21 / Friday, January 31, 2020 / Notices approach if it satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 This draft 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 601.12 and Form FDA 356h have been approved under OMB control number 0910–0338; the collections of information in 21 CFR parts 610 and 630 have been approved under OMB control numbers 0910– 0116. III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics/ biologics-guidances or https:// www.regulations.gov. Dated: January 27, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–01815 Filed 1–30–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Meeting of the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: In accordance with the Federal Advisory Committee Act, this notice announces that the Centers for Disease Control and Prevention (CDC)/ HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHAC) has scheduled a public meeting. Information about CHAC can be found at https:// www.cdc.gov/maso/facm/facm CHACHSPT.html. DATES: March 5, 2020, 3:00 p.m.—4:00 p.m. Eastern Time (ET). ADDRESSES: This meeting will be held by webinar and will accommodate up to 100 attendees. To access the virtual meeting, please use the information below. jbell on DSKJLSW7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:16 Jan 30, 2020 Jkt 250001 • Webinar link: https:// hrsa.connectsolutions.com/chac_ business_meeting/ • Conference call-in number: Æ Call in: 888–790–1964. Æ Passcode: 1251991. and phone number listed above at least 10 business days prior to the meeting. Maria G. Button, Director, Division of the Executive Secretariat. [FR Doc. 2020–01809 Filed 1–30–20; 8:45 am] BILLING CODE 4165–15–P FOR FURTHER INFORMATION CONTACT: Theresa Jumento, Public Health Advisor, HIV/AIDS Bureau, HRSA, 5600 Fishers Lane, Rockville, Maryland 20857; 301–443–5807; or CHACAdvisoryComm@hrsa.gov. DEPARTMENT OF HEALTH AND HUMAN SERVICES CHAC was established under Section 222 of the Public Health Service (PHS) Act, [42 U.S.C. Section 217a], as amended. The purpose of CHAC is to advise the Secretary of HHS, the Director of CDC, and the HRSA Administrator regarding objectives, strategies, policies, and priorities for HIV, viral hepatitis, and other STDs; prevention and treatment efforts including surveillance of HIV infection, viral hepatitis, other STDs, and related behaviors; epidemiologic, behavioral, health services, and laboratory research on HIV, viral hepatitis, and other STDs; identification of policy issues related to HIV/viral hepatitis/STD professional eduction, patient healthcare delivery, and prevention services; agency policies about prevention of HIV, viral hepatitis and other STDs; treatment, healthcare delivery, and research and training; strategic issues influencing the ability of CDC and HRSA to fulfill their missions of providing prevention and treatment services; programmatic efforts to prevent and treat HIV, viral hepatitis, and other STDs; and support to the agencies in their developoment of responses to emerging health needs related to HIV, viral hepatitis, and other STDs. During the March 5, 2020, meeting, CHAC will discuss issues related to a CDC pilot on recency assay-based incidence estimation and the President’s initiative on ‘‘Ending the HIV Epidemic: A Plan for America.’’ Agenda items are subject to change as priorities dictate. Due to the nature and time limitations of the meeting, members of the public will not have an opportunity to provide oral comments, although written comments may be submitted prior to the meeting, or up to 5 business days after the meeting, to Theresa Jumento at the contact information listed above. Individuals who plan to attend and need special assistance or another reasonable accommodation should notify Theresa Jumento at the address National Advisory Committee on Rural Health and Human Services SUPPLEMENTARY INFORMATION: PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 Health Resources and Services Administration Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: In accordance with the Federal Advisory Committee Act, this notice announces that the Secretary’s National Advisory Committee on Rural Health and Human Services (NACRHHS) has scheduled a public meeting. Information about NACRHHS and the agenda for this meeting can be found on the NACRHHS website at https://www.hrsa.gov/advisorycommittees/rural-health/. DATES: March 2, 2020, 8:30 a.m.–5:15 p.m. Eastern Time (ET); March 3, 2020, 8:30 a.m.–5:15 p.m. ET; and March 4, 2020, 8:30 a.m.–11:15 a.m. ET. ADDRESSES: The address for the meeting is the Center for Disease Control and Prevention (CDC) Global Communications Center (GCC) Auditorium B3, 1600 Clifton Road, Atlanta, GA 30329. On the morning of March 3, 2020, NACRHHS will break into subcommittees. One subcommittee will travel to Mercer School of Medicine, 1550 College St., Macon, GA 31207. The other subcommittee will travel to Health Services Center, 608 Martin Luther King Drive, Hobson City, AL 36201. In the afternoon, at approximately 4:00 p.m. ET., NACRHHS will reconvene at the CDC GCC. FOR FURTHER INFORMATION CONTACT: Steven Hirsch, Administrative Coordinator at the Federal Office of Rural Health Policy, HRSA, 5600 Fishers Lane, 17W59D, Rockville, Maryland 20857; 301–443–7322; or shirsch@hrsa.gov. SUPPLEMENTARY INFORMATION: NACRHHS provides advice and recommendations to the Secretary of HHS (Secretary) on policy, program development, and other matters of significance concerning both rural health and rural human services. SUMMARY: E:\FR\FM\31JAN1.SGM 31JAN1

Agencies

[Federal Register Volume 85, Number 21 (Friday, January 31, 2020)]
[Notices]
[Pages 5668-5670]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01815]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0307]


Recommendations To Reduce the Possible Risk of Transmission of 
Creutzfeldt-Jakob Disease and Variant Creutzfeldt Jakob Disease by 
Blood and Blood Components; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance entitled ``Recommendations to 
Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease 
and Variant Creutzfeldt Jakob Disease by Blood and Blood Components.'' 
The draft guidance provides blood establishments that collect blood and 
blood components with revised recommendations intended to reduce the 
possible risk of transmission of Creutzfeldt-Jakob disease (CJD) and 
variant Creutzfeldt-Jakob disease (vCJD) by blood and blood components. 
The recommendations in the draft guidance apply to the collection of 
Whole Blood and blood components intended for transfusion or for use in 
further manufacturing, including Source Plasma. The draft guidance 
replaces the document entitled ``Amendment to `Revised Preventive 
Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-
Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood 
Products,' '' Draft Guidance for Industry, dated December 2017, and 
when finalized, will supersede the document entitled ``Revised 
Preventive Measures to Reduce the Possible Risk of Transmission of 
Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by 
Blood and Blood Products, Guidance for Industry,'' dated May 2010 and 
updated January 2016.

DATES: Submit either electronic or written comments on the draft 
guidance by March 31, 2020 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

[[Page 5669]]

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-2012-D-0307 for ``Recommendations to Reduce the Possible Risk of 
Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt Jakob 
Disease by Blood and Blood Components.'' 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.
     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.
    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 draft 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 draft 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 draft 
guidance document.

FOR FURTHER INFORMATION CONTACT: Sana F. Hussain, 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 draft guidance entitled 
``Recommendations to Reduce the Possible Risk of Transmission of 
Creutzfeldt-Jakob Disease and Variant Creutzfeldt Jakob Disease by 
Blood and Blood Components.'' The draft guidance provides blood 
establishments that collect blood and blood components with revised 
recommendations intended to reduce the possible risk of transmission of 
CJD and vCJD by blood and blood components. The recommendations in the 
draft guidance apply to the collection of Whole Blood and blood 
components intended for transfusion or for use in further 
manufacturing, including Source Plasma. FDA is revising or removing our 
current recommendations to screen blood donors for: (1) Geographic risk 
of possible exposure to bovine spongiform encephalopathy, including 
time spent on U.S. military bases in Europe; (2) receipt of a blood 
transfusion in certain vCJD risk countries; (3) risk factors for 
iatrogenic CJD (i.e., a history of taking human cadaveric pituitary-
derived growth hormone; (4) having blood relatives with CJD; and (5) a 
history of injecting bovine insulin.
    In the Federal Register of December 22, 2017 (82 FR 60747), FDA 
announced the availability of the draft document entitled ``Amendment 
to `Revised Preventive Measures to Reduce the Possible Risk of 
Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob 
Disease by Blood and Blood Products' '' dated December 2017 (December 
2017 draft guidance). FDA received several comments on the December 
2017 draft guidance. Based on those comments, FDA is announcing a 
revised draft guidance. The draft guidance announced in this notice 
replaces the December 2017 draft guidance, and, when finalized, will 
supersede the document entitled ``Revised Preventive Measures to Reduce 
the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and 
Variant Creutzfeldt-Jakob Disease by Blood and Blood Products, Guidance 
for Industry,'' dated May 2010 and updated January 2016.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on 
recommendations to reduce the possible risk of transmission of CJD and 
vCJD by blood and blood components. It does not establish any rights 
for any person and is not binding on FDA or the public. You can use an 
alternative

[[Page 5670]]

approach if it satisfies the requirements of the applicable statutes 
and regulations.

II. Paperwork Reduction Act of 1995

    This draft 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 601.12 and Form FDA 356h have been 
approved under OMB control number 0910-0338; the collections of 
information in 21 CFR parts 610 and 630 have been approved under OMB 
control numbers 0910-0116.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances or 
https://www.regulations.gov.

    Dated: January 27, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-01815 Filed 1-30-20; 8:45 am]
 BILLING CODE 4164-01-P
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