80 FR 77645 - Use of Nucleic Acid Tests To Reduce the Risk of Transmission of West Nile Virus From Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 240 (December 15, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 240 (December 15, 2015)
| Page Range | 77645-77646 | |
| FR Document | 2015-31405 |
[Federal Register Volume 80, Number 240 (Tuesday, December 15, 2015)] [Notices] [Pages 77645-77646] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-31405] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-1143] Use of Nucleic Acid Tests To Reduce the Risk of Transmission of West Nile Virus From Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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 document entitled ``Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry.'' The draft guidance document provides establishments that make donor eligibility determinations for donors of HCT/Ps with recommendations for testing living donors for West Nile Virus (WNV). The draft guidance recommends the use of an FDA- licensed nucleic acid test (NAT) to test living donors of HCT/Ps for evidence of infection with WNV. The guidance does not provide recommendations regarding testing of cadaveric HCT/P donors for WNV. The draft guidance replaces the draft guidance entitled ``Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)'' dated October 2013. The donor testing recommendations in the draft guidance, when finalized, will supplement the donor screening recommendations for WNV (which will remain in place) and supersede the ``West Nile Virus (WNV)'' section in Appendix 6 of the guidance entitled ``Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)'' dated August 2007 (2007 Donor Eligibility Guidance). DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by March 14, 2016. 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-2013-D-1143 for ``Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential [[Page 77646]] 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 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 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: Jonathan McKnight, 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 document entitled ``Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus From Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry.'' The draft guidance document provides establishments that make donor eligibility determinations for donors of HCT/Ps with recommendations for testing living donors for WNV. The draft guidance recommends an FDA-licensed NAT to test living donors of HCT/Ps for evidence of infection with WNV. The guidance does not provide recommendations regarding testing of cadaveric HCT/P donors for WNV. FDA believes that the use of an FDA-licensed NAT will reduce the risk of transmission of WNV from living donors of HCT/Ps and therefore recommends that you use an FDA-licensed NAT for testing living donors of HCT/Ps for infection with WNV. The 2007 Donor Eligibility Guidance indicated that FDA may recommend routine use of an appropriate, licensed donor screening test(s) to detect acute infections with WNV using NAT technology, once such tests were available. In the Federal Register of October 24, 2013 (78 FR 63476), FDA announced the availability of the draft guidance entitled ``Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)'' dated October 2013 (October 2013 draft guidance). FDA received several comments on the draft guidance and those comments were considered as this draft guidance was developed. In the Federal Register of February 28, 2007 (72 FR 9007), FDA announced the availability of the 2007 Donor Eligibility Guidance. FDA issued a revised version of this guidance under the same title, dated August 2007 (2007 Donor Eligibility Guidance). The draft guidance announced in this notice replaces the October 2013 draft guidance and when finalized, will supplement sections IV.E. (recommendations 15 and 16), IV.F. (recommendation 5), and supersede the ``West Nile Virus (WNV)'' section in Appendix 6 of the 2007 Donor Eligibility Guidance. The 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 ``Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft 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. Electronic Access Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov. Dated: December 8, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-31405 Filed 12-14-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 240 / Tuesday, December 15, 2015 / Notices 77645
became effective: June 22, 2003. The Dated: December 7, 2015. considers your comment on this draft
applicant claims July 18, 2003, as the Leslie Kux, guidance before it begins work on the
date the investigational new drug Associate Commissioner for Policy. final version of the guidance, submit
application (IND) became effective. [FR Doc. 2015–31400 Filed 12–14–15; 8:45 am] either electronic or written comments
However, FDA records indicate that the BILLING CODE 4164–01–P
on the draft guidance by March 14,
IND effective date was June 22, 2003, 2016.
which was 30 days after FDA receipt of ADDRESSES: You may submit comments
the IND. DEPARTMENT OF HEALTH AND as follows:
2. The date the application was HUMAN SERVICES
Electronic Submissions
initially submitted with respect to the Food and Drug Administration
human biological product under section Submit electronic comments in the
351 of the Public Health Service Act (42 [Docket No. FDA–2013–D–1143] following way:
U.S.C. 262): May 14, 2009. The • Federal eRulemaking Portal: http://
applicant claims June 15, 2012, as the Use of Nucleic Acid Tests To Reduce www.regulations.gov. Follow the
date the biologics license application the Risk of Transmission of West Nile instructions for submitting comments.
Virus From Living Donors of Human Comments submitted electronically,
(BLA) for RAXIBACUMAB (BLA
Cells, Tissues, and Cellular and including attachments, to http://
125349/0) was initially submitted.
Tissue-Based Products; Draft www.regulations.gov will be posted to
However, FDA records indicate that
Guidance for Industry; Availability the docket unchanged. Because your
BLA 125349/0 was submitted on May
comment will be made public, you are
14, 2009. AGENCY: Food and Drug Administration, solely responsible for ensuring that your
3. The date the application was HHS. comment does not include any
approved: December 14, 2012. FDA has ACTION: Notice of availability. confidential information that you or a
verified the applicant’s claim that BLA third party may not wish to be posted,
SUMMARY: The Food and Drug
125349/0 was approved on December such as medical information, your or
Administration (FDA or Agency) is
14, 2012. anyone else’s Social Security number, or
announcing the availability of a draft
This determination of the regulatory confidential business information, such
document entitled ‘‘Use of Nucleic Acid
review period establishes the maximum as a manufacturing process. Please note
Tests to Reduce the Risk of
potential length of a patent extension. that if you include your name, contact
Transmission of West Nile Virus from
However, the USPTO applies several information, or other information that
Living Donors of Human Cells, Tissues,
statutory limitations in its calculations identifies you in the body of your
and Cellular and Tissue-Based Products
comments, that information will be
of the actual period for patent extension. (HCT/Ps); Draft Guidance for Industry.’’
posted on http://www.regulations.gov.
In its application for patent extension, The draft guidance document provides
• If you want to submit a comment
this applicant seeks 412 days of patent establishments that make donor
with confidential information that you
term extension. eligibility determinations for donors of
do not wish to be made available to the
HCT/Ps with recommendations for
III. Petitions public, submit the comment as a
testing living donors for West Nile Virus
written/paper submission and in the
Anyone with knowledge that any of (WNV). The draft guidance recommends
manner detailed (see ‘‘Written/Paper
the dates as published are incorrect may the use of an FDA-licensed nucleic acid
Submissions’’ and ‘‘Instructions’’).
submit either electronic or written test (NAT) to test living donors of HCT/
comments and ask for a redetermination Ps for evidence of infection with WNV. Written/Paper Submissions
The guidance does not provide Submit written/paper submissions as
(see DATES). Furthermore, any interested
recommendations regarding testing of follows:
person may petition FDA for a
cadaveric HCT/P donors for WNV. The • Mail/Hand delivery/Courier (for
determination regarding whether the
draft guidance replaces the draft written/paper submissions): Division of
applicant for extension acted with due guidance entitled ‘‘Draft Guidance for
diligence during the regulatory review Dockets Management (HFA–305), Food
Industry: Use of Nucleic Acid Tests to and Drug Administration, 5630 Fishers
period. To meet its burden, the petition Reduce the Risk of Transmission of
must be timely (see DATES) and contain Lane, Rm. 1061, Rockville, MD 20852.
West Nile Virus from Donors of Human • For written/paper comments
sufficient facts to merit an FDA Cells, Tissues, and Cellular and Tissue-
investigation. (See H. Rept. 857, part 1, submitted to the Division of Dockets
Based Products (HCT/Ps)’’ dated Management, FDA will post your
98th Cong., 2d sess., pp. 41–42, 1984.) October 2013. The donor testing
Petitions should be in the format comment, as well as any attachments,
recommendations in the draft guidance, except for information submitted,
specified in 21 CFR 10.30. when finalized, will supplement the marked and identified, as confidential,
Submit petitions electronically to donor screening recommendations for if submitted as detailed in
http://www.regulations.gov at Docket WNV (which will remain in place) and ‘‘Instructions.’’
No. FDA–2013–S–0610. Submit written supersede the ‘‘West Nile Virus (WNV)’’ Instructions: All submissions received
petitions (two copies are required) to the section in Appendix 6 of the guidance must include the Docket No. FDA–
Division of Dockets Management (HFA– entitled ‘‘Guidance for Industry: 2013–D–1143 for ‘‘Use of Nucleic Acid
asabaliauskas on DSK5VPTVN1PROD with NOTICES
305), Food and Drug Administration, Eligibility Determination for Donors of Tests to Reduce the Risk of
5630 Fishers Lane, Rm. 1061, Rockville, Human Cells, Tissues, and Cellular and Transmission of West Nile Virus from
MD 20852. Petitions that have not been Tissue-Based Products (HCT/Ps)’’ dated Living Donors of Human Cells, Tissues,
made publicly available on http:// August 2007 (2007 Donor Eligibility and Cellular and Tissue-Based Products
www.regulations.gov may be viewed in Guidance). (HCT/Ps); Draft Guidance for Industry.’’
the Division of Dockets Management DATES: Although you can comment on Received comments will be placed in
between 9 a.m. and 4 p.m., Monday any guidance at any time (see 21 CFR the docket and, except for those
through Friday. 10.115(g)(5)), to ensure that the Agency submitted as ‘‘Confidential
VerDate Sep<11>2014 17:08 Dec 14, 2015 Jkt 238001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\15DEN1.SGM 15DEN1](https://thefederalregister.org/doc/80_FR_77885/page/1.svg)
![77646 Federal Register / Vol. 80, No. 240 / Tuesday, December 15, 2015 / Notices
Submissions,’’ publicly viewable at FOR FURTHER INFORMATION CONTACT: Appendix 6 of the 2007 Donor
http://www.regulations.gov or at the Jonathan McKnight, Center for Biologics Eligibility Guidance.
Division of Dockets Management Evaluation and Research, Food and The draft guidance is being issued
between 9 a.m. and 4 p.m., Monday Drug Administration, 10903 New consistent with FDA’s good guidance
through Friday. Hampshire Ave. Bldg. 71, Rm. 7301, practices regulation (21 CFR 10.115).
• Confidential Submissions—To Silver Spring, MD 20993–0002, 240– The draft guidance, when finalized, will
submit a comment with confidential 402–7911. represent the current thinking of FDA
information that you do not wish to be SUPPLEMENTARY INFORMATION: on ‘‘Use of Nucleic Acid Tests to
made publicly available submit your Reduce the Risk of Transmission of
comments only as a written/paper I. Background
West Nile Virus from Living Donors of
submission. You should submit two FDA is announcing the availability of Human Cells, Tissues, and Cellular and
copies total. One copy will include the a draft document entitled ‘‘Use of Tissue-Based Products (HCT/Ps); Draft
information you claim to be confidential Nucleic Acid Tests to Reduce the Risk Guidance for Industry.’’ It does not
with a heading or cover note that states of Transmission of West Nile Virus establish any rights for any person and
‘‘THIS DOCUMENT CONTAINS From Living Donors of Human Cells, is not binding on FDA or the public.
CONFIDENTIAL INFORMATION.’’ The Tissues, and Cellular and Tissue-Based You can use an alternative approach if
Agency will review this copy, including Products (HCT/Ps); Draft Guidance for it satisfies the requirements of the
the claimed confidential information, in Industry.’’ The draft guidance document applicable statutes and regulations.
its consideration of comments. The provides establishments that make
second copy, which will have the donor eligibility determinations for II. Electronic Access
claimed confidential information donors of HCT/Ps with Persons with access to the Internet
redacted/blacked out, will be available recommendations for testing living may obtain the draft guidance at either
for public viewing and posted on donors for WNV. The draft guidance http://www.fda.gov/Biologics
http://www.regulations.gov. Submit recommends an FDA-licensed NAT to BloodVaccines/Guidance
both copies to the Division of Dockets test living donors of HCT/Ps for ComplianceRegulatoryInformation/
Management. If you do not wish your evidence of infection with WNV. The Guidances/default.htm or http://
name and contact information to be guidance does not provide www.regulations.gov.
made publicly available, you can recommendations regarding testing of
Dated: December 8, 2015.
provide this information on the cover cadaveric HCT/P donors for WNV. FDA
sheet and not in the body of your believes that the use of an FDA-licensed Leslie Kux,
comments and you must identify this NAT will reduce the risk of Associate Commissioner for Policy.
information as ‘‘confidential.’’ Any transmission of WNV from living donors [FR Doc. 2015–31405 Filed 12–14–15; 8:45 am]
information marked as ‘‘confidential’’ of HCT/Ps and therefore recommends BILLING CODE 4164–01–P
will not be disclosed except in that you use an FDA-licensed NAT for
accordance with 21 CFR 10.20 and other testing living donors of HCT/Ps for
applicable disclosure law. For more infection with WNV. The 2007 Donor DEPARTMENT OF HEALTH AND
information about FDA’s posting of Eligibility Guidance indicated that FDA HUMAN SERVICES
comments to public dockets, see 80 FR may recommend routine use of an
56469, September 18, 2015, or access appropriate, licensed donor screening Indian Health Service
the information at: http://www.fda.gov/ test(s) to detect acute infections with [OMB Control Number 0917–0034]
regulatoryinformation/dockets/default. WNV using NAT technology, once such
htm. tests were available. Request for Public Comment: 30-Day
Docket: For access to the docket to In the Federal Register of October 24, Proposed Information Collection:
read background documents or the 2013 (78 FR 63476), FDA announced the Indian Health Service (IHS) Sharing
electronic and written/paper comments availability of the draft guidance What Works—Best Practice, Promising
received, go to http:// entitled ‘‘Draft Guidance for Industry: Practice, and Local Effort (BPPPLE)
www.regulations.gov and insert the Use of Nucleic Acid Tests to Reduce the Form
docket number, found in brackets in the Risk of Transmission of West Nile Virus
heading of this document, into the from Donors of Human Cells, Tissues, AGENCY: Indian Health Service, HHS.
‘‘Search’’ box and follow the prompts and Cellular and Tissue-Based Products ACTION: Notice; correction.
and/or go to the Division of Dockets (HCT/Ps)’’ dated October 2013 (October
Management, 5630 Fishers Lane, Rm. 2013 draft guidance). FDA received SUMMARY: The Indian Health Service
1061, Rockville, MD 20852. several comments on the draft guidance published a 30 day Federal Register
Submit written requests for single and those comments were considered as notice in the Federal Register (FR) on
copies of the draft guidance to the Office this draft guidance was developed. November 17, 2015 (80 FR 71813) to
of Communication, Outreach and In the Federal Register of February solicit comments from the general
Development, Center for Biologics 28, 2007 (72 FR 9007), FDA announced public on the information collection
Evaluation and Research (CBER), Food the availability of the 2007 Donor titled, ‘‘Indian Health Service (IHS)
and Drug Administration, 10903 New Eligibility Guidance. FDA issued a Sharing What Works—Best Practice,
Hampshire Ave. Bldg. 71, Rm. 3128, revised version of this guidance under Promising Practice, and Local Effort
Silver Spring, MD 20993–0002. Send the same title, dated August 2007 (2007 (BPPPLE) Form,’’ Office of Management
asabaliauskas on DSK5VPTVN1PROD with NOTICES
one self-addressed adhesive label to Donor Eligibility Guidance). and Budget (OMB) Control Number
assist the office in processing your The draft guidance announced in this 0917–0034. The notice was submitted
requests. The draft guidance may also be notice replaces the October 2013 draft before the 60 day FR notice comment
obtained by mail by calling CBER at 1– guidance and when finalized, will period for the same information
800–835–4709 or 240–402–8010. See supplement sections IV.E. collection ends on December 8, 2015.
the SUPPLEMENTARY INFORMATION section (recommendations 15 and 16), IV.F. Therefore, the correct date for the
for electronic access to the draft (recommendation 5), and supersede the deadline to submit comments regarding
guidance document. ‘‘West Nile Virus (WNV)’’ section in the 30 day FR notice is January 9, 2016.
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Document Created: 2018-03-02 09:16:09
Document Modified: 2018-03-02 09:16:09
| 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 | Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by March 14, 2016. | |
| Contact | Jonathan McKnight, 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 | 80 FR 77645 |
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