80 FR 54289 - Use of Donor Screening Tests To Test Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products for Infection With Treponema pallidum
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 174 (September 9, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 174 (September 9, 2015)
| Page Range | 54289-54290 | |
| FR Document | 2015-22677 |
[Federal Register Volume 80, Number 174 (Wednesday, September 9, 2015)] [Notices] [Pages 54289-54290] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-22677] ----------------------------------------------------------------------- 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 The guidance announced in this notice finalizes the draft guidance of the same title, dated October 2013.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
![Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Notices 54289
to residents of Illinois with funding SUPPLEMENTARY INFORMATION: In 2012, etiologic agent of syphilis. HCT/P
from the Retirement Research n4a and NASUAD were awarded grants Establishments must, as required under
Foundation. Additional funds are from ACL to build the business capacity Federal regulations, test a donor
needed to leverage the foundation’s of state and community-based aging and specimen for evidence of T. pallidum
funding, in order to ensure that the disability organizations for managed infection using appropriate FDA-
current provision of services to Illinois long-term services and supports licensed, approved, or cleared donor
residents will be continued. This (MLTSS). This one-year of grant screening tests, in accordance with the
supplementary funding would be funding, through continuation grant, manufacturer’s instructions, unless an
provided for the approved period. will continue to support n4a and exception to this requirement applies.
Authority: This program is authorized NASUAD in their efforts to: The guidance clarifies that FDA does
under Title II of the Older Americans Act • Identify and track emerging trends, not consider diagnostic tests or pre-
(OAA) (42 U.S.C. 3032), as amended by the best practices, barriers, lessons learned amendment devices (which have not
Older Americans Act Amendments of 2006, and progress in the aging and disability been licensed, approved, or cleared) to
Public Law 109–365. networks’ integration into MLTSS and be adequate for use in donor testing for
(Catalog of Federal Domestic Assistance delivery system reform; T. pallidum infection under the criteria
93.048). • increase state and community-based specified in Federal regulations. The
aging and disability organizations’ guidance announced in this notice
Dated: August 14, 2015. capacity, readiness and involvement in finalizes the draft guidance of the same
Kathy Greenlee, the provision of MLTSS through the title, dated October 2013. The
Assistant Secretary for Aging and provision of broad-based and targeted recommendations in the guidance
Administrator, Administration for technical assistance, education and
Community Living.
announced in this notice supersedes
training; and those recommendations for testing HCT/
[FR Doc. 2015–22630 Filed 9–8–15; 8:45 am] • develop products that complement P donors for evidence of T. pallidum
BILLING CODE 4154–01–P and enhance the first two areas of focus. infection contained in the document
This program is authorized under the entitled ‘‘Guidance for Industry:
Older Americans Act of 1965, as Eligibility Determination for Donors of
DEPARTMENT OF HEALTH AND amended in 2006, Public Law 109–365.
HUMAN SERVICES Human Cells, Tissues, and Cellular and
Dated: August 28, 2015. Tissue-Based Products (HCT/Ps),’’ dated
Administration for Community Living Sharon Lewis, August 2007.
Principal Deputy Administrator, DATES: Submit either electronic or
Announcement of the Intent To Award Administration for Community Living. written comments on Agency guidances
Single-Source Grants to the National [FR Doc. 2015–22631 Filed 9–8–15; 8:45 am] at any time.
Association of Area Agencies on BILLING CODE 4154–01–P ADDRESSES: Submit written requests for
Aging and the National Association of single copies of the guidance to the
States United for Aging and Office of Communication, Outreach and
Disabilities DEPARTMENT OF HEALTH AND Development, Center for Biologics
HUMAN SERVICES Evaluation and Research (CBER), Food
AGENCY: Administration for Community
Living, HHS. and Drug Administration, 10903 New
Food and Drug Administration
Hampshire Ave., Bldg. 71, Rm. 3128,
ACTION: Notice. [Docket No. FDA–2013–D–1213] Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
SUMMARY: The Administration for Use of Donor Screening Tests To Test assist the office in processing your
Community Living (ACL) announces the Donors of Human Cells, Tissues, and requests. The guidance may also be
intent to award, subject to the Cellular and Tissue-Based Products obtained by mail by calling CBER at 1–
availability of funds, single-source grant for Infection With Treponema pallidum 800–835–4709 or 240–402–8010. See
awards in the amount of $335,000 to the (Syphilis); Guidance for Industry; the SUPPLEMENTARY INFORMATION section
National Association of Area Agencies Availability for electronic access to the guidance
on Aging (n4a) and $153,500 to the
AGENCY: Food and Drug Administration, document.
National Association of State United for
HHS. Submit electronic comments on the
Aging and Disabilities (NASUAD). The
ACTION: Notice. guidance to http://www.regulations.gov.
awards will continue supporting and
Submit written comments to the
stimulating the ongoing work by these
SUMMARY: The Food and Drug Division of Dockets Management (HFA–
organizations to further develop and
Administration (FDA or Agency) is 305), Food and Drug Administration,
assist states and community-based
announcing the availability of a 5630 Fishers Lane, Rm. 1061, Rockville,
organizations with building their
document entitled ‘‘Use of Donor MD 20852.
business capacity for managed long-
Screening Tests to Test Donors of FOR FURTHER INFORMATION CONTACT: Paul
term services and supports and delivery
Human Cells, Tissues and Cellular and E. Levine, Jr., Center for Biologics
system reform. CFDA Numbers: 93.048
Tissue-Based Products for Infection Evaluation and Research, Food and
DATES: The awards will be issued for a with Treponema pallidum (Syphilis); Drug Administration, 10903 New
project period of September 30, 2015 Guidance for Industry.’’ The guidance Hampshire Ave., Bldg. 71, Rm. 7301,
through September 29, 2016. document provides establishments that Silver Spring, MD 20993–0002, 240–
Lhorne on DSK5TPTVN1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT: make donor eligibility determinations 402–7911.
Marisa Scala-Foley, Office of Integrated for donors of human cells, tissues, and SUPPLEMENTARY INFORMATION:
Care Innovations, Administration for cellular and tissue-based products
Community Living, 1 Massachusetts (HCT/P Establishments) with updated I. Background
Avenue NW., Washington, DC 20001. recommendations concerning donor FDA is announcing the availability of
Telephone: 202–357–3516; Email: testing for evidence of Treponema a document entitled ‘‘Use of Donor
Marisa.Scala-Foley@acl.hhs.gov. pallidum (T. pallidum) infection, the Screening Tests to Test Donors of
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![54290 Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Notices
Human Cells, Tissues and Cellular and contained in the 2007 Donor Eligibility sixth annual scientific workshop co-
Tissue-Based Products for Infection guidance. sponsored by FDA and the Coalition
with Treponema pallidum (Syphilis); The guidance is being issued Against Major Diseases Consortium of
Guidance for Industry.’’ The guidance consistent with FDA’s good guidance the Critical Path Institute, contained
document provides HCT/P practices regulation (21 CFR 10.115). incorrect Web links for online
Establishments with updated The guidance represents the current registration and for the FDA Meeting
recommendations concerning donor thinking of FDA on ‘‘Use of Donor Information Page (where the workshop
testing for evidence of T. pallidum Screening Tests to Test Donors of agenda will be made available) and an
infection. HCT/P Establishments must, Human Cells, Tissues and Cellular and incorrect registration deadline. This
as required under § 1271.80(a) and (c) Tissue-Based Products for Infection document corrects those errors.
(21 CFR 1271.80(a) and (c)), test a donor with Treponema pallidum (Syphilis); FOR FURTHER INFORMATION CONTACT:
specimen for evidence of infection due Guidance for Industry.’’ It does not Jacqueline Brooks-Leighton, Center for
to T. pallidum using appropriate FDA- establish any rights for any person and Drug Evaluation and Research, Food
licensed, approved, or cleared donor is not binding on FDA or the public. and Drug Administration, 10903 New
screening tests, in accordance with the You can use an alternative approach if Hampshire Ave., Bldg. 21, Rm. 4521,
manufacturer’s instructions, unless an it satisfies the requirements of the Silver Spring, MD 20993, 240–402–
exception to this requirement applies applicable statutes and regulations. 5292, FAX: 301–796–9907, email:
under 21 CFR 1271.90. The guidance II. Comments jacqueline.brooks-leighton@fda.hhs.gov.
clarifies that FDA does not consider SUPPLEMENTARY INFORMATION: In FR Doc.
diagnostic tests or pre-amendment Interested persons may submit either 2015–18969, appearing on page 45998,
devices (which have not been licensed, electronic comments regarding this in the Federal Register of Monday
approved, or cleared) to be adequate for document to http://www.regulations.gov August 3, 2015, the following
use in donor testing for T. pallidum or written comments to the Division of corrections are made:
infection under the criteria specified in Dockets Management (see ADDRESSES). It On page 45998, in the second full
§ 1271.80(c). FDA will no longer is only necessary to send one set of paragraph of the third column, the
exercise enforcement discretion that comments. Identify comments with the registration link, https://
permits the use of diagnostic syphilis docket number found in brackets in the www.SignUp4.net/public/ap.aspx?EID=
tests or pre-amendments devices for use heading of this document. Received SIXT10E, is corrected to read http://
as an HCT/P donor screening test comments may be seen in the Division www.cvent.com/events/6th-annual-
because the wide availability of FDA- of Dockets Management between 9 a.m. coalition-against-major-diseases-food-
licensed, approved, or cleared test and 4 p.m., Monday through Friday, and and-drug-administration-scientific-
systems with an indication for use in will be posted to the docket at http:// workshop-public-/invitation-ed6c207
donor screening no longer supports www.regulations.gov. cbf09447185a891e4bf62ad7a.aspx?i=
such enforcement discretion. FDA III. Electronic Access 70715ca1-f255-46b2-a370-
recommends that HCT/P Establishments 3fe3881bbab2.
Persons with access to the Internet On page 45998, in the third full
implement the recommendations in the
may obtain the guidance at either paragraph of the third column, the
guidance as soon as feasible, but not
http://www.fda.gov/BiologicsBlood registration deadline, October 14, 2015,
later than 6 months after issuance of this
Vaccines/GuidanceCompliance is corrected to read October 13, 2015.
guidance.
RegulatoryInformation/Guidances/ On page 45998, in the third full
In the Federal Register of November default.htm or http://
5, 2013 (78 FR 66366), FDA announced paragraph of the third column, the link
www.regulations.gov. for the FDA Meeting information page,
the availability of the draft guidance of
Dated: September 2, 2015. http://www.fda.gov/Drugs/NewsEvents/
the same title, dated October 2013. FDA
Leslie Kux, ucm410863.htm, is corrected to read
received several comments on the draft
Associate Commissioner for Policy. http://www.fda.gov/Drugs/NewsEvents/
guidance and those comments were
ucm457486.htm.
considered as the guidance was [FR Doc. 2015–22677 Filed 9–8–15; 8:45 am]
finalized. FDA did not make changes to BILLING CODE 4164–01–P Dated: September 2, 2015.
the recommendations in the draft Leslie Kux,
guidance. FDA made editorial changes Associate Commissioner for Policy.
to improve clarity. The guidance DEPARTMENT OF HEALTH AND [FR Doc. 2015–22674 Filed 9–8–15; 8:45 am]
announced in this notice finalizes the HUMAN SERVICES BILLING CODE 4164–01–P
draft guidance dated October 2013.
Food and Drug Administration
In the Federal Register of February
28, 2007 (72 FR 9007), FDA announced [Docket No. FDA–2015–N–0001] DEPARTMENT OF HEALTH AND
the availability of the guidance entitled HUMAN SERVICES
‘‘Guidance for Industry: Eligibility Sixth Annual Coalition Against Major
Determination for Donors of Human Diseases/Food and Drug Food and Drug Administration
Cells, Tissues, and Cellular and Tissue- Administration Scientific Workshop; [Docket No. FDA–2015–N–3015]
Based Products (HCT/Ps),’’ dated Public Workshop; Correction
February 2007. FDA issued a revised AGENCY: Food and Drug Administration, Use of Databases for Establishing the
version of this guidance under the same HHS. Clinical Relevance of Human Genetic
Lhorne on DSK5TPTVN1PROD with NOTICES
title, dated August 2007 (hereafter Variants; Public Workshop; Request
ACTION: Notice; correction.
referred to as the 2007 Donor Eligibility for Comments
guidance). The guidance announced in SUMMARY: The Food and Drug AGENCY: Food and Drug Administration,
this notice supersedes the Administration (FDA) is correcting a HHS.
recommendations on compliance with notice that appeared in the Federal
ACTION: Notice of public workshop;
the requirements for testing HCT/P Register of August 3, 2015 (80 FR
request for comments.
donors for T. pallidum that are 45998). That notice, announcing the
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Document Created: 2015-12-15 09:53:04
Document Modified: 2015-12-15 09:53:04
| 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. | |
| Dates | Submit either electronic or written comments on Agency guidances at any time. | |
| 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. | |
| FR Citation | 80 FR 54289 |
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