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; Availability, 36593-36594 [2020-13055]

Download as PDF Federal Register / Vol. 85, No. 117 / Wednesday, June 17, 2020 / Notices redirecting significant resources to support these policies. We will use this mechanism to test messages about regulated drug products on a variety of subjects related to consumer, patient, or health care professional perceptions and about use of drug products and related materials, including but not limited to, direct-to-consumer prescription drug promotion, physician labeling of prescription drugs, medication guides, over-the-counter drug labeling, emerging risk communications, patient labeling, online sale of medical products, and consumer and professional education. Annually, we project about 45 communication studies using the variety of test methods listed 36593 in this document. We are requesting an extension of these burden hours so as not to restrict our ability to gather information on public sentiment for its proposals in its regulatory and communications programs. We estimate the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Activity Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours Interviews/Surveys ............................ 43,875 1 43,875 0.21925 (12 minutes) ....................... 9,620 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Our estimated burden for the information collection has not changed since the last OMB approval. Dated: June 5, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–13079 Filed 6–16–20; 8:45 am] BILLING CODE 4164–01–P guidance of the same title dated January 2020, and supersedes 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. The announcement of the guidance is published in the Federal Register on June 17, 2020. DATES: DEPARTMENT OF HEALTH AND HUMAN SERVICES [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; Guidance for Industry; Availability AGENCY: 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 entitled ‘‘Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt Jakob Disease by Blood and Blood Components.’’ The 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 guidance apply to the collection of Whole Blood and blood components intended for transfusion or for use in further manufacturing, including Source Plasma. The guidance finalizes the draft khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:44 Jun 16, 2020 Jkt 250001 You may submit either electronic or written comments on Agency guidances at any time as follows: ADDRESSES: Food and Drug Administration 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’’). PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 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 E:\FR\FM\17JNN1.SGM 17JNN1 36594 Federal Register / Vol. 85, No. 117 / Wednesday, June 17, 2020 / Notices 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 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: khammond on DSKJM1Z7X2PROD with NOTICES 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: II. Paperwork Reduction Act of 1995 I. Background FDA is announcing the availability of a guidance entitled ‘‘Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt Jakob Disease by Blood and Blood Components.’’ This document was posted on FDA’s website on April 2, 2020 (see section III for electronic access to the guidance). The guidance provides blood establishments that collect blood VerDate Sep<11>2014 16:44 Jun 16, 2020 Jkt 250001 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 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 prior 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 January 31, 2020 (85 FR 5668), FDA announced the availability of the draft guidance of the same title dated January 2020. FDA received several comments on the draft guidance and those comments were considered as the guidance was finalized. Based on these comments, editorial changes were made to improve clarity. The guidance announced in this notice finalizes the draft guidance dated January 2020, and supersedes 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 guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents 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 approach if it satisfies the requirements of the applicable statutes and regulations. 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 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 PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 630 have been approved under OMB control number 0910–0116. 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 or https:// www.regulations.gov. Dated: June 12, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–13055 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–N–0965] Request for Nominations for Voting Members on a Public Advisory Committee; Pharmacy Compounding Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) is requesting nominations for members to serve on the Pharmacy Compounding Advisory Committee (the Committee), Division of Advisory Committee and Consultant Management, Center for Drug Evaluation and Research. The Committee provides advice on scientific, technical, and medical issues concerning human drug compounding under the Federal Food, Drug, and Cosmetic Act (FD&C Act), and, as required, any other product for which FDA has regulatory responsibility, and makes appropriate recommendations to the Commissioner of Food and Drugs. DATES: Nominations received on or before August 17, 2020, will be given first consideration for membership on the Pharmacy Compounding Advisory Committee. Nominations received after August 17, 2020, will be considered for nominations to the Committee as later vacancies occur. ADDRESSES: All nominations for membership should be sent electronically by logging into the FDA Advisory Committee Nomination Portal: https://www.accessdata.fda.gov/scripts/ FACTRSPortal/FACTRS/index.cfm or by mail to Advisory Committee Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, SUMMARY: E:\FR\FM\17JNN1.SGM 17JNN1

Agencies

[Federal Register Volume 85, Number 117 (Wednesday, June 17, 2020)]
[Notices]
[Pages 36593-36594]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13055]


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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; 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 final 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 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 guidance apply to the collection of Whole Blood 
and blood components intended for transfusion or for use in further 
manufacturing, including Source Plasma. The guidance finalizes the 
draft guidance of the same title dated January 2020, and supersedes 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: 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:

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

[[Page 36594]]

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 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: 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 guidance entitled 
``Recommendations to Reduce the Possible Risk of Transmission of 
Creutzfeldt-Jakob Disease and Variant Creutzfeldt Jakob Disease by 
Blood and Blood Components.'' This document was posted on FDA's website 
on April 2, 2020 (see section III for electronic access to the 
guidance). The 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 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 prior 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 January 31, 2020 (85 FR 5668), FDA 
announced the availability of the draft guidance of the same title 
dated January 2020. FDA received several comments on the draft guidance 
and those comments were considered as the guidance was finalized. Based 
on these comments, editorial changes were made to improve clarity. The 
guidance announced in this notice finalizes the draft guidance dated 
January 2020, and supersedes 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 guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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 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 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 number 0910-0116.

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 or 
https://www.regulations.gov.

    Dated: June 12, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-13055 Filed 6-16-20; 8:45 am]
BILLING CODE 4164-01-P
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