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of Transmission of West Nile Virus From Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry; Availability, 77645-77646 [2015-31405]

Download as PDF Federal Register / Vol. 80, No. 240 / Tuesday, December 15, 2015 / Notices became effective: June 22, 2003. The applicant claims July 18, 2003, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was June 22, 2003, which was 30 days after FDA receipt of the IND. 2. The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C. 262): May 14, 2009. The applicant claims June 15, 2012, as the date the biologics license application (BLA) for RAXIBACUMAB (BLA 125349/0) was initially submitted. However, FDA records indicate that BLA 125349/0 was submitted on May 14, 2009. 3. The date the application was approved: December 14, 2012. FDA has verified the applicant’s claim that BLA 125349/0 was approved on December 14, 2012. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 412 days of patent term extension. asabaliauskas on DSK5VPTVN1PROD with NOTICES III. Petitions Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and ask for a redetermination (see DATES). Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must be timely (see DATES) and contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Submit petitions electronically to https://www.regulations.gov at Docket No. FDA–2013–S–0610. Submit written petitions (two copies are required) to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Petitions that have not been made publicly available on https:// www.regulations.gov may be viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. VerDate Sep<11>2014 17:08 Dec 14, 2015 Jkt 238001 Dated: December 7, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–31400 Filed 12–14–15; 8:45 am] BILLING CODE 4164–01–P 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. 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 TissueBased 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). SUMMARY: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency DATES: PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 77645 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: 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): 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 E:\FR\FM\15DEN1.SGM 15DEN1 asabaliauskas on DSK5VPTVN1PROD with NOTICES 77646 Federal Register / Vol. 80, No. 240 / Tuesday, December 15, 2015 / Notices Submissions,’’ publicly viewable at https://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 https://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: https://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 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 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. VerDate Sep<11>2014 17:08 Dec 14, 2015 Jkt 238001 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 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 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 https://www.fda.gov/Biologics BloodVaccines/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service [OMB Control Number 0917–0034] Request for Public Comment: 30-Day Proposed Information Collection: Indian Health Service (IHS) Sharing What Works—Best Practice, Promising Practice, and Local Effort (BPPPLE) Form Indian Health Service, HHS. Notice; correction. AGENCY: ACTION: The Indian Health Service published a 30 day Federal Register notice in the Federal Register (FR) on November 17, 2015 (80 FR 71813) to solicit comments from the general public on the information collection titled, ‘‘Indian Health Service (IHS) Sharing What Works—Best Practice, Promising Practice, and Local Effort (BPPPLE) Form,’’ Office of Management and Budget (OMB) Control Number 0917–0034. The notice was submitted before the 60 day FR notice comment period for the same information collection ends on December 8, 2015. Therefore, the correct date for the deadline to submit comments regarding the 30 day FR notice is January 9, 2016. SUMMARY: E:\FR\FM\15DEN1.SGM 15DEN1

Agencies

[Federal Register Volume 80, Number 240 (Tuesday, December 15, 2015)]
[Notices]
[Pages 77645-77646]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: 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): 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 https://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 https://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: https://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 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 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 https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://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
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