Use of Donor Screening Tests To Test Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products for Infection With Treponema pallidum, 54289-54290 [2015-22677]

Download as PDF Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Notices to residents of Illinois with funding from the Retirement Research Foundation. Additional funds are needed to leverage the foundation’s funding, in order to ensure that the current provision of services to Illinois residents will be continued. This supplementary funding would be provided for the approved period. Authority: This program is authorized under Title II of the Older Americans Act (OAA) (42 U.S.C. 3032), as amended by the Older Americans Act Amendments of 2006, Public Law 109–365. (Catalog of Federal Domestic Assistance 93.048). Dated: August 14, 2015. Kathy Greenlee, Assistant Secretary for Aging and Administrator, Administration for Community Living. [FR Doc. 2015–22630 Filed 9–8–15; 8:45 am] BILLING CODE 4154–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Community Living Announcement of the Intent To Award Single-Source Grants to the National Association of Area Agencies on Aging and the National Association of States United for Aging and Disabilities Administration for Community Living, HHS. ACTION: Notice. AGENCY: The Administration for Community Living (ACL) announces the intent to award, subject to the availability of funds, single-source grant awards in the amount of $335,000 to the National Association of Area Agencies on Aging (n4a) and $153,500 to the National Association of State United for Aging and Disabilities (NASUAD). The awards will continue supporting and stimulating the ongoing work by these organizations to further develop and assist states and community-based organizations with building their business capacity for managed longterm services and supports and delivery system reform. CFDA Numbers: 93.048 DATES: The awards will be issued for a project period of September 30, 2015 through September 29, 2016. FOR FURTHER INFORMATION CONTACT: Marisa Scala-Foley, Office of Integrated Care Innovations, Administration for Community Living, 1 Massachusetts Avenue NW., Washington, DC 20001. Telephone: 202–357–3516; Email: Marisa.Scala-Foley@acl.hhs.gov. Lhorne on DSK5TPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 14:19 Sep 08, 2015 Jkt 235001 In 2012, n4a and NASUAD were awarded grants from ACL to build the business capacity of state and community-based aging and disability organizations for managed long-term services and supports (MLTSS). This one-year of grant funding, through continuation grant, will continue to support n4a and NASUAD in their efforts to: • Identify and track emerging trends, best practices, barriers, lessons learned and progress in the aging and disability networks’ integration into MLTSS and delivery system reform; • increase state and community-based aging and disability organizations’ capacity, readiness and involvement in the provision of MLTSS through the provision of broad-based and targeted technical assistance, education and training; and • develop products that complement and enhance the first two areas of focus. This program is authorized under the Older Americans Act of 1965, as amended in 2006, Public Law 109–365. SUPPLEMENTARY INFORMATION: Dated: August 28, 2015. Sharon Lewis, Principal Deputy Administrator, Administration for Community Living. [FR Doc. 2015–22631 Filed 9–8–15; 8:45 am] BILLING CODE 4154–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–D–1213] Use of Donor Screening Tests To Test Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products for Infection With Treponema pallidum (Syphilis); Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ‘‘Use of Donor Screening Tests to Test Donors of Human Cells, Tissues and Cellular and Tissue-Based Products for Infection with Treponema pallidum (Syphilis); Guidance for Industry.’’ The guidance document provides establishments that make donor eligibility determinations for donors of human cells, tissues, and cellular and tissue-based products (HCT/P Establishments) with updated recommendations concerning donor testing for evidence of Treponema pallidum (T. pallidum) infection, the SUMMARY: PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 54289 etiologic agent of syphilis. HCT/P Establishments must, as required under Federal regulations, test a donor specimen for evidence of T. pallidum infection using appropriate FDAlicensed, approved, or cleared donor screening tests, in accordance with the manufacturer’s instructions, unless an exception to this requirement applies. The guidance clarifies that FDA does not consider diagnostic tests or preamendment devices (which have not been licensed, approved, or cleared) to be adequate for use in donor testing for T. pallidum infection under the criteria specified in Federal regulations. The guidance announced in this notice finalizes the draft guidance of the same title, dated October 2013. The recommendations in the guidance announced in this notice supersedes those recommendations for testing HCT/ P donors for evidence of T. pallidum infection contained in the document entitled ‘‘Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps),’’ dated August 2007. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: 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. Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Paul E. Levine, Jr., 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 ‘‘Use of Donor Screening Tests to Test Donors of E:\FR\FM\09SEN1.SGM 09SEN1 Lhorne on DSK5TPTVN1PROD with NOTICES 54290 Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Notices Human Cells, Tissues and Cellular and Tissue-Based Products for Infection with Treponema pallidum (Syphilis); Guidance for Industry.’’ The guidance document provides HCT/P Establishments with updated recommendations concerning donor testing for evidence of T. pallidum infection. HCT/P Establishments must, as required under § 1271.80(a) and (c) (21 CFR 1271.80(a) and (c)), test a donor specimen for evidence of infection due to T. pallidum using appropriate FDAlicensed, approved, or cleared donor screening tests, in accordance with the manufacturer’s instructions, unless an exception to this requirement applies under 21 CFR 1271.90. The guidance clarifies that FDA does not consider diagnostic tests or pre-amendment devices (which have not been licensed, approved, or cleared) to be adequate for use in donor testing for T. pallidum infection under the criteria specified in § 1271.80(c). FDA will no longer exercise enforcement discretion that permits the use of diagnostic syphilis tests or pre-amendments devices for use as an HCT/P donor screening test because the wide availability of FDAlicensed, approved, or cleared test systems with an indication for use in donor screening no longer supports such enforcement discretion. FDA recommends that HCT/P Establishments implement the recommendations in the guidance as soon as feasible, but not later than 6 months after issuance of this guidance. In the Federal Register of November 5, 2013 (78 FR 66366), FDA announced the availability of the draft guidance of the same title, dated October 2013. FDA received several comments on the draft guidance and those comments were considered as the guidance was finalized. FDA did not make changes to the recommendations in the draft guidance. FDA made editorial changes to improve clarity. The guidance announced in this notice finalizes the draft guidance dated October 2013. In the Federal Register of February 28, 2007 (72 FR 9007), FDA announced the availability of the guidance entitled ‘‘Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and TissueBased Products (HCT/Ps),’’ dated February 2007. FDA issued a revised version of this guidance under the same title, dated August 2007 (hereafter referred to as the 2007 Donor Eligibility guidance). The guidance announced in this notice supersedes the recommendations on compliance with the requirements for testing HCT/P donors for T. pallidum that are VerDate Sep<11>2014 14:19 Sep 08, 2015 Jkt 235001 contained in the 2007 Donor Eligibility guidance. The 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 ‘‘Use of Donor Screening Tests to Test Donors of Human Cells, Tissues and Cellular and Tissue-Based Products for Infection with Treponema pallidum (Syphilis); 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. Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http:// www.regulations.gov. III. Electronic Access Persons with access to the Internet may obtain the guidance at either http://www.fda.gov/BiologicsBlood Vaccines/GuidanceCompliance RegulatoryInformation/Guidances/ default.htm or http:// www.regulations.gov. Dated: September 2, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–22677 Filed 9–8–15; 8:45 am] sixth annual scientific workshop cosponsored by FDA and the Coalition Against Major Diseases Consortium of the Critical Path Institute, contained incorrect Web links for online registration and for the FDA Meeting Information Page (where the workshop agenda will be made available) and an incorrect registration deadline. This document corrects those errors. FOR FURTHER INFORMATION CONTACT: Jacqueline Brooks-Leighton, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 4521, Silver Spring, MD 20993, 240–402– 5292, FAX: 301–796–9907, email: jacqueline.brooks-leighton@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In FR Doc. 2015–18969, appearing on page 45998, in the Federal Register of Monday August 3, 2015, the following corrections are made: On page 45998, in the second full paragraph of the third column, the registration link, https:// www.SignUp4.net/public/ap.aspx?EID= SIXT10E, is corrected to read http:// www.cvent.com/events/6th-annualcoalition-against-major-diseases-foodand-drug-administration-scientificworkshop-public-/invitation-ed6c207 cbf09447185a891e4bf62ad7a.aspx?i= 70715ca1-f255-46b2-a3703fe3881bbab2. On page 45998, in the third full paragraph of the third column, the registration deadline, October 14, 2015, is corrected to read October 13, 2015. On page 45998, in the third full paragraph of the third column, the link for the FDA Meeting information page, http://www.fda.gov/Drugs/NewsEvents/ ucm410863.htm, is corrected to read http://www.fda.gov/Drugs/NewsEvents/ ucm457486.htm. BILLING CODE 4164–01–P Dated: September 2, 2015. Leslie Kux, Associate Commissioner for Policy. DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2015–22674 Filed 9–8–15; 8:45 am] BILLING CODE 4164–01–P Food and Drug Administration DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA–2015–N–0001] Sixth Annual Coalition Against Major Diseases/Food and Drug Administration Scientific Workshop; Public Workshop; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of August 3, 2015 (80 FR 45998). That notice, announcing the SUMMARY: PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 Food and Drug Administration [Docket No. FDA–2015–N–3015] Use of Databases for Establishing the Clinical Relevance of Human Genetic Variants; Public Workshop; Request for Comments AGENCY: Food and Drug Administration, HHS. Notice of public workshop; request for comments. ACTION: E:\FR\FM\09SEN1.SGM 09SEN1

Agencies

[Federal Register Volume 80, Number 174 (Wednesday, September 9, 2015)]
[Notices]
[Pages 54289-54290]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-22677]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1213]


Use of Donor Screening Tests To Test Donors of Human Cells, 
Tissues, and Cellular and Tissue-Based Products for Infection With 
Treponema pallidum (Syphilis); Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a document entitled ``Use of Donor Screening Tests 
to Test Donors of Human Cells, Tissues and Cellular and Tissue-Based 
Products for Infection with Treponema pallidum (Syphilis); Guidance for 
Industry.'' The guidance document provides establishments that make 
donor eligibility determinations for donors of human cells, tissues, 
and cellular and tissue-based products (HCT/P Establishments) with 
updated recommendations concerning donor testing for evidence of 
Treponema pallidum (T. pallidum) infection, the etiologic agent of 
syphilis. HCT/P Establishments must, as required under Federal 
regulations, test a donor specimen for evidence of T. pallidum 
infection using appropriate FDA-licensed, approved, or cleared donor 
screening tests, in accordance with the manufacturer's instructions, 
unless an exception to this requirement applies. The guidance clarifies 
that FDA does not consider diagnostic tests or pre-amendment devices 
(which have not been licensed, approved, or cleared) to be adequate for 
use in donor testing for T. pallidum infection under the criteria 
specified in Federal regulations. The guidance announced in this notice 
finalizes the draft guidance of the same title, dated October 2013. The 
recommendations in the guidance announced in this notice supersedes 
those recommendations for testing HCT/P donors for evidence of T. 
pallidum infection contained in the document entitled ``Guidance for 
Industry: Eligibility Determination for Donors of Human Cells, Tissues, 
and Cellular and Tissue-Based Products (HCT/Ps),'' dated August 2007.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: 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.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Paul E. Levine, Jr., 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 ``Use of 
Donor Screening Tests to Test Donors of

[[Page 54290]]

Human Cells, Tissues and Cellular and Tissue-Based Products for 
Infection with Treponema pallidum (Syphilis); Guidance for Industry.'' 
The guidance document provides HCT/P Establishments with updated 
recommendations concerning donor testing for evidence of T. pallidum 
infection. HCT/P Establishments must, as required under Sec.  
1271.80(a) and (c) (21 CFR 1271.80(a) and (c)), test a donor specimen 
for evidence of infection due to T. pallidum using appropriate FDA-
licensed, approved, or cleared donor screening tests, in accordance 
with the manufacturer's instructions, unless an exception to this 
requirement applies under 21 CFR 1271.90. The guidance clarifies that 
FDA does not consider diagnostic tests or pre-amendment devices (which 
have not been licensed, approved, or cleared) to be adequate for use in 
donor testing for T. pallidum infection under the criteria specified in 
Sec.  1271.80(c). FDA will no longer exercise enforcement discretion 
that permits the use of diagnostic syphilis tests or pre-amendments 
devices for use as an HCT/P donor screening test because the wide 
availability of FDA-licensed, approved, or cleared test systems with an 
indication for use in donor screening no longer supports such 
enforcement discretion. FDA recommends that HCT/P Establishments 
implement the recommendations in the guidance as soon as feasible, but 
not later than 6 months after issuance of this guidance.
    In the Federal Register of November 5, 2013 (78 FR 66366), FDA 
announced the availability of the draft guidance of the same title, 
dated October 2013. FDA received several comments on the draft guidance 
and those comments were considered as the guidance was finalized. FDA 
did not make changes to the recommendations in the draft guidance. FDA 
made editorial changes to improve clarity. The guidance announced in 
this notice finalizes the draft guidance dated October 2013.
    In the Federal Register of February 28, 2007 (72 FR 9007), FDA 
announced the availability of the guidance entitled ``Guidance for 
Industry: Eligibility Determination for Donors of Human Cells, Tissues, 
and Cellular and Tissue-Based Products (HCT/Ps),'' dated February 2007. 
FDA issued a revised version of this guidance under the same title, 
dated August 2007 (hereafter referred to as the 2007 Donor Eligibility 
guidance). The guidance announced in this notice supersedes the 
recommendations on compliance with the requirements for testing HCT/P 
donors for T. pallidum that are contained in the 2007 Donor Eligibility 
guidance.
    The 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 ``Use of Donor Screening Tests to Test 
Donors of Human Cells, Tissues and Cellular and Tissue-Based Products 
for Infection with Treponema pallidum (Syphilis); 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. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

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: September 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-22677 Filed 9-8-15; 8:45 am]
 BILLING CODE 4164-01-P