Sixth Annual Coalition Against Major Diseases/Food and Drug Administration Scientific Workshop; Public Workshop; Correction, 54290 [2015-22674]

Download as PDF 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 In the Federal Register of November 5, 2013 (78 FR 66366), FDA announced the availability of the draft guidance of the same title, dated October 2013. FDA received several comments on the draft guidance and those comments were considered as the guidance was finalized. FDA did not make changes to the recommendations in the draft guidance.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 The guidance announced in this notice finalizes the draft guidance dated October 2013.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]
[Page 54290]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-22674]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[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.

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SUMMARY: 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 sixth annual scientific workshop co-
sponsored 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-annual-coalition-against-major-diseases-food-and-drug-administration-scientific-workshop-public-/invitation-ed6c207cbf09447185a891e4bf62ad7a.aspx?i=70715ca1-f255-46b2-a370-3fe3881bbab2.
    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.

    Dated: September 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-22674 Filed 9-8-15; 8:45 am]
 BILLING CODE 4164-01-P