81 FR 1957 - 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; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 9 (January 14, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 9 (January 14, 2016)
| Page Range | 1957-1958 | |
| FR Document | 2016-00536 |
[Federal Register Volume 81, Number 9 (Thursday, January 14, 2016)] [Notices] [Pages 1957-1958] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-00536] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0307] 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; 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 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.'' The guidance document provides blood collecting establishments and manufacturers of plasma derivatives with comprehensive recommendations intended to minimize the possible risk of transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) from blood and blood products. The guidance amends the guidance document entitled ``Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products'' dated May 2010 (2010 guidance) by finalizing and incorporating the recommendations from the draft document entitled ``Draft Guidance for Industry: Amendment to 'Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products''' dated June 2012 (2012 draft guidance). DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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 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. Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov. Submit both copies to the Division of Dockets Management. 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 [[Page 1958]] the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 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: Tami Belouin, 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 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.'' The guidance document provides blood collecting establishments and manufacturers of plasma derivatives with comprehensive recommendations intended to minimize the possible risk of transmission of CJD and vCJD from blood and blood products. The guidance is the latest in a series of guidances addressing the risk of CJD and vCJD transmission by blood and blood products. The guidance amends the 2010 guidance (May 27, 2010; 75 FR 29768) and finalizes the 2012 draft guidance (June 11, 2012; 77 FR 34390) by providing revised labeling recommendations for plasma-derived products, including albumin and products containing plasma-derived albumin. The guidance also provides manufacturers of plasma-derived products with recommendations on how to report the labeling changes to FDA under 21 CFR 601.12. Additional changes to the guidance include adding information in the background section relevant to the new labeling recommendations; providing updated information on the global vCJD and Bovine Spongiform Encephalopathy epidemics; clarifying the reentry criteria for a donor with a family history of CJD; clarifying the requirements related to biological product deviation reporting; and, updating, adding, and removing certain footnotes and references. FDA received four comments on the 2012 draft guidance, and those comments were considered in the finalization of the draft guidance. This guidance does not address potential changes to the geographic exposure based deferrals for risk of vCJD. FDA discussed such potential changes with its Transmissible Spongiform Encephalopathies Advisory Committee in June 2015 and intends to address revised recommendations for geographic donor deferrals in future guidance documents. 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 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. 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. 3501-3520). The collections of information in 21 CFR 601.12 have been approved under OMB control number 0910-0338; the collections of information in 21 CFR 606.100 have been approved under OMB control number 0910-0116; and the collections of information in 21 CFR 600.14 and 606.171 have been approved under OMB control number 0910-0458. III. Electronic Access Persons with access to the Internet may obtain the guidance at either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov. Dated: January 7, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-00536 Filed 1-13-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 9 / Thursday, January 14, 2016 / Notices 1957
included general topics for discussion announcing the availability of a written/paper submission and in the
in this document. If you do request to document entitled ‘‘Revised Preventive manner detailed (see ‘‘Written/Paper
present public comments, please list Measures to Reduce the Possible Risk of Submissions’’ and ‘‘Instructions’’).
which topics you wish to address. FDA Transmission of Creutzfeldt-Jakob
Written/Paper Submissions
will do its best to accommodate requests Disease and Variant Creutzfeldt-Jakob
to make public comment. Following the Disease by Blood and Blood Products; Submit written/paper submissions as
close of registration, FDA will Guidance for Industry.’’ The guidance follows:
determine the amount of time allotted to document provides blood collecting • Mail/Hand delivery/Courier (for
each presenter and the approximate establishments and manufacturers of written/paper submissions): Division of
time each oral presentation is to begin, plasma derivatives with comprehensive Dockets Management (HFA–305), Food
and will select and notify participants recommendations intended to minimize and Drug Administration, 5630 Fishers
by February 24, 2016. All requests to the possible risk of transmission of Lane, Rm. 1061, Rockville, MD 20852.
make oral presentations must be Creutzfeldt-Jakob Disease (CJD) and • For written/paper comments
received by the close of registration on Variant Creutzfeldt-Jakob Disease (vCJD) submitted to the Division of Dockets
Management, FDA will post your
February 24, 2016, at 4 p.m. If selected from blood and blood products. The
comment, as well as any attachments,
for presentation, any presentation guidance amends the guidance
except for information submitted,
materials must be emailed to Cara document entitled ‘‘Guidance for
marked and identified, as confidential,
Tenenbaum (see FURTHER INFORMATION Industry: Revised Preventive Measures
if submitted as detailed in
CONTACT) no later than February 26, to Reduce the Possible Risk of
‘‘Instructions.’’
2016. No commercial promotional Transmission of Creutzfeldt-Jakob Instructions: All submissions received
material will be permitted to be Disease (CJD) and Variant Creutzfeldt- must include the Docket No. FDA–
presented or distributed at the public Jakob Disease (vCJD) by Blood and 2012–D–0307 for Revised Preventive
workshop. Blood Products’’ dated May 2010 (2010 Measures to Reduce the Possible Risk of
Transcripts: Please be advised that as guidance) by finalizing and Transmission of Creutzfeldt-Jakob
soon as a transcript is available, it will incorporating the recommendations Disease and Variant Creutzfeldt-Jakob
be accessible at http://www. from the draft document entitled ‘‘Draft Disease by Blood and Blood Products;
regulations.gov. It may be viewed at the Guidance for Industry: Amendment to Guidance for Industry. Received
Division of Dockets Management (see ’Guidance for Industry: Revised comments will be placed in the docket
ADDRESSES). A transcript will also be Preventive Measures to Reduce the and, except for those submitted as
available in either hardcopy or on CD– Possible Risk of Transmission of ‘‘Confidential Submissions,’’ publicly
ROM, after submission of a Freedom of Creutzfeldt-Jakob Disease and Variant viewable at http://www.regulations.gov
Information request. The Freedom of Creutzfeldt-Jakob Disease by Blood and or at the Division of Dockets
Information office address is available Blood Products’’’ dated June 2012 (2012 Management between 9 a.m. and 4 p.m.,
on the Agency’s Web site at http:// draft guidance). Monday through Friday.
www.fda.gov. A link to the transcripts DATES: Submit either electronic or • Confidential Submissions—To
will also be available approximately 45 written comments on Agency guidances submit a comment with confidential
days after the public workshop on the at any time. information that you do not wish to be
Internet at http://www.fda.gov/Medical ADDRESSES: You may submit comments made publicly available, submit your
Devices/NewsEvents/Workshops as follows: comments only as a written/paper
Conferences/default.htm. (Select this submission. You should submit two
public workshop from the posted events Electronic Submissions copies total. One copy will include the
list.) Submit electronic comments in the information you claim to be confidential
Dated: January 7, 2016. following way: with a heading or cover note that states
Leslie Kux, • Federal eRulemaking Portal: http:// ‘‘THIS DOCUMENT CONTAINS
Associate Commissioner for Policy. www.regulations.gov. Follow the CONFIDENTIAL INFORMATION’’. The
[FR Doc. 2016–00540 Filed 1–13–16; 8:45 am]
instructions for submitting comments. Agency will review this copy, including
Comments submitted electronically, the claimed confidential information, in
BILLING CODE 4164–01–P
including attachments, to http:// its consideration of comments. The
www.regulations.gov will be posted to second copy, which will have the
DEPARTMENT OF HEALTH AND the docket unchanged. Because your claimed confidential information
HUMAN SERVICES comment will be made public, you are redacted/blacked out, will be available
solely responsible for ensuring that your for public viewing and posted on
Food and Drug Administration comment does not include any http://www.regulations.gov. Submit
confidential information that you or a both copies to the Division of Dockets
[Docket No. FDA–2012–D–0307] third party may not wish to be posted, Management. If you do not wish your
such as medical information, your or name and contact information to be
Revised Preventive Measures To
anyone else’s Social Security number, or made publicly available, you can
Reduce the Possible Risk of
confidential business information, such provide this information on the cover
Transmission of Creutzfeldt-Jakob
as a manufacturing process. Please note sheet and not in the body of your
Disease and Variant Creutzfeldt-Jakob
that if you include your name, contact comments and you must identify this
Disease by Blood and Blood Products;
mstockstill on DSK4VPTVN1PROD with NOTICES
information, or other information that information as ‘‘confidential.’’ Any
Guidance for Industry; Availability
identifies you in the body of your information marked as ‘‘confidential’’
AGENCY: Food and Drug Administration, comments, that information will be will not be disclosed except in
HHS. posted on http://www.regulations.gov. accordance with 21 CFR 10.20 and other
ACTION: Notice of availability. • If you want to submit a comment applicable disclosure law. For more
with confidential information that you information about FDA’s posting of
SUMMARY: The Food and Drug do not wish to be made available to the comments to public dockets, see 80 FR
Administration (FDA or Agency) is public, submit the comment as a 56469, September 18, 2015, or access
VerDate Sep<11>2014 16:39 Jan 13, 2016 Jkt 238001 PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 E:\FR\FM\14JAN1.SGM 14JAN1](https://thefederalregister.org/doc/81_FR_1966/page/1.svg)
![1958 Federal Register / Vol. 81, No. 9 / Thursday, January 14, 2016 / Notices
the information at: http://www.fda.gov/ products with recommendations on how default.htm or http://
regulatoryinformation/dockets/ to report the labeling changes to FDA www.regulations.gov.
default.htm. under 21 CFR 601.12. Additional Dated: January 7, 2016.
Docket: For access to the docket to changes to the guidance include adding Leslie Kux,
read background documents or the information in the background section
Associate Commissioner for Policy.
electronic and written/paper comments relevant to the new labeling
[FR Doc. 2016–00536 Filed 1–13–16; 8:45 am]
received, go to http:// recommendations; providing updated
BILLING CODE 4164–01–P
www.regulations.gov and insert the information on the global vCJD and
docket number, found in brackets in the Bovine Spongiform Encephalopathy
heading of this document, into the epidemics; clarifying the reentry criteria
DEPARTMENT OF HEALTH AND
‘‘Search’’ box and follow the prompts for a donor with a family history of CJD;
HUMAN SERVICES
and/or go to the Division of Dockets clarifying the requirements related to
Management, 5630 Fishers Lane, Rm. biological product deviation reporting; National Institutes of Health
1061, Rockville, MD 20852. and, updating, adding, and removing
Submit written requests for single certain footnotes and references. FDA Proposed Collection; 60-Day Comment
copies of the guidance to the Office of received four comments on the 2012 Request; Self-Affirmation Construct
Communication, Outreach, and draft guidance, and those comments Validity (NCI)
Development, Center for Biologics were considered in the finalization of
Evaluation and Research (CBER), Food the draft guidance. SUMMARY: In compliance with the
and Drug Administration, 10903 New This guidance does not address requirement of Section 3506(c)(2)(A) of
Hampshire Ave., Bldg. 71, Rm. 3128, potential changes to the geographic the Paperwork Reduction Act of 1995,
exposure based deferrals for risk of for opportunity for public comment on
Silver Spring, MD 20993–0002. Send
vCJD. FDA discussed such potential proposed data collection projects, the
one self-addressed adhesive label to
changes with its Transmissible National Cancer Institute, the National
assist the office in processing your
Spongiform Encephalopathies Advisory Institutes of Health (NIH) will publish
requests. The guidance may also be
Committee in June 2015 and intends to periodic summaries of proposed
obtained by mail by calling CBER at 1–
address revised recommendations for projects to be submitted to the Office of
800–835–4709 or 240–402–8010. See
geographic donor deferrals in future Management and Budget (OMB) for
the SUPPLEMENTARY INFORMATION section
guidance documents. review and approval.
for electronic access to the guidance Written comments and/or suggestions
document. This guidance is being issued
consistent with FDA’s good guidance from the public and affected agencies
FOR FURTHER INFORMATION CONTACT: practices regulation (21 CFR 10.115). are invited to address one or more of the
Tami Belouin, Center for Biologics The guidance represents the current following points: (1) Whether the
Evaluation and Research, Food and thinking of FDA on Revised Preventive proposed collection of information is
Drug Administration, 10903 New Measures to Reduce the Possible Risk of necessary for the proper performance of
Hampshire Ave., Bldg. 71, Rm. 7301, Transmission of Creutzfeldt-Jakob the function of the agency, including
Silver Spring, MD 20993–0002, 240– Disease and Variant Creutzfeldt-Jakob whether the information will have
402–7911. Disease by Blood and Blood Products; practical utility; (2) The accuracy of the
SUPPLEMENTARY INFORMATION: Guidance for Industry. It does not agency’s estimate of the burden of the
establish any rights for any person and proposed collection of information,
I. Background including the validity of the
is not binding on FDA or the public.
FDA is announcing the availability of You can use an alternative approach if methodology and assumptions used; (3)
a document entitled ‘‘Revised it satisfies the requirements of the The quality, utility, and clarity of the
Preventive Measures to Reduce the applicable statutes and regulations. information to be collected; and (4)
Possible Risk of Transmission of Minimize the burden of the collection of
Creutzfeldt-Jakob Disease and Variant II. Paperwork Reduction Act of 1995 information on those who are to
Creutzfeldt-Jakob Disease by Blood and This guidance refers to previously respond, including the use of
Blood Products; Guidance for Industry.’’ approved collections of information appropriate automated, electronic,
The guidance document provides blood found in FDA regulations. These mechanical, or other technological
collecting establishments and collections of information are subject to collection techniques or other forms of
manufacturers of plasma derivatives review by the Office of Management and information technology.
with comprehensive recommendations Budget (OMB) under the Paperwork To Submit Comments and for Further
intended to minimize the possible risk Reduction Act of 1995 (44 U.S.C. 3501– Information: To obtain a copy of the
of transmission of CJD and vCJD from 3520). The collections of information in data collection plans and instruments,
blood and blood products. The guidance 21 CFR 601.12 have been approved submit comments in writing, or request
is the latest in a series of guidances under OMB control number 0910–0338; more information on the proposed
addressing the risk of CJD and vCJD the collections of information in 21 CFR project, contact*: Rebecca Ferrer,
transmission by blood and blood 606.100 have been approved under Program Director, Basic Biobehavioral
products. OMB control number 0910–0116; and and Psychological Sciences Branch,
The guidance amends the 2010 the collections of information in 21 CFR Behavioral Research Program, Division
guidance (May 27, 2010; 75 FR 29768) 600.14 and 606.171 have been approved of Cancer Control and Population
mstockstill on DSK4VPTVN1PROD with NOTICES
and finalizes the 2012 draft guidance under OMB control number 0910–0458. Sciences, National Cancer Institute,
(June 11, 2012; 77 FR 34390) by 9609 Medical Center Dr., Rockville MD
providing revised labeling III. Electronic Access 20852. or call non-toll-free number (240)
recommendations for plasma-derived Persons with access to the Internet 276–6914 or Email your request,
products, including albumin and may obtain the guidance at either including your address to: ferrerra@
products containing plasma-derived http://www.fda.gov/BiologicsBlood mail.nih.gov. Formal requests for
albumin. The guidance also provides Vaccines/GuidanceCompliance additional plans and instruments must
manufacturers of plasma-derived RegulatoryInformation/Guidances/ be requested in writing.
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Document Created: 2016-01-14 02:50:19
Document Modified: 2016-01-14 02:50:19
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | Submit either electronic or written comments on Agency guidances at any time. | |
| Contact | Tami Belouin, 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. | |
| FR Citation | 81 FR 1957 |
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