81 FR 79034 - Amendment to Guidance for Industry: Use of Serological Tests To Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 218 (November 10, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 218 (November 10, 2016)
| Page Range | 79034-79035 | |
| FR Document | 2016-27107 |
[Federal Register Volume 81, Number 218 (Thursday, November 10, 2016)] [Notices] [Pages 79034-79035] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-27107] [[Page 79034]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0137] Amendment to Guidance for Industry: Use of Serological Tests To Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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 ``Amendment to Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion; Draft Guidance for Industry.'' The draft guidance document, when finalized, is intended to amend the document entitled ``Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion'' dated December 2010 (2010 Chagas Guidance) by expanding the scope of the guidance to include the collection of blood and blood components for use in manufacturing a product, including donations intended as a component of, or used to manufacture, a medical device; removing the recommendation to ask donors about a history of Chagas disease; and providing a recommendation for a reentry algorithm for donors deferred on the basis of screening test results for antibodies to Trypanosoma cruzi (T. cruzi) or on the basis of answering ``yes'' to the Chagas screening question. Further, the guidance is intended to notify blood establishments that collect blood and blood components that FDA has licensed a supplemental test for antibodies to T. cruzi and further testing of donations found repeatedly reactive to a screening test for T. cruzi is therefore required. The draft guidance does not apply to the collection of Source Plasma. 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 February 8, 2017. 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-2009-D-0137 for ``Amendment to Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion; Draft Guidance for Industry.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential 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: Tami Belouin, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New [[Page 79035]] 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 ``Amendment to Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion; Draft Guidance for Industry.'' The draft guidance, when finalized, is intended to amend the 2010 Chagas Guidance (75 FR 75810, December 6, 2010) by expanding the scope of the guidance to include the collection of blood and blood components for use in manufacturing a product, including donations intended as a component of, or used to manufacture, a medical device; removing the recommendation to ask donors about a history of Chagas disease; and providing a recommendation for a reentry algorithm for donors deferred on the basis of screening test results for antibodies to T. cruzi or on the basis of answering ``yes'' to the Chagas screening question. In the Federal Register of May 22, 2015 (80 FR 29842), FDA published the final rule entitled ``Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use.'' The final rule became effective May 23, 2016. The draft guidance is intended to notify blood establishments that collect blood and blood components that T. cruzi is defined as a relevant transfusion- transmitted infection in 21 CFR 630.3(h)(1), subject to the testing requirements in 21 CFR 610.40, the donor deferral practices in 21 CFR 610.41, and the donor notification requirements in 21 CFR 630.40 under the final rule. In addition, the draft guidance is intended to notify blood establishments that collect blood and blood components that FDA has licensed a supplemental test for antibodies to T. cruzi and further testing of donations found repeatedly reactive to a screening test for T. cruzi is therefore required under 21 CFR 610.40(e). The draft guidance does not apply to the collection of Source Plasma. All other recommendations in the 2010 Chagas Guidance would remain unchanged. This 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 ``Amendment to Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion; 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. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR 601.12 have been approved under OMB control number 0910-0338; and the collections of information in 21 CFR 610.40 and 630.40 have been approved under OMB control numbers 0910-0116 and 0910-0795. III. 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: November 3, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-27107 Filed 11-9-16; 8:45 am] BILLING CODE 4164-01-P
![79034 Federal Register / Vol. 81, No. 218 / Thursday, November 10, 2016 / Notices
DEPARTMENT OF HEALTH AND on the draft guidance by February 8, • Confidential Submissions—To
HUMAN SERVICES 2017. submit a comment with confidential
ADDRESSES: You may submit comments information that you do not wish to be
Food and Drug Administration as follows: made publicly available, submit your
comments only as a written/paper
[Docket No. FDA–2009–D–0137] Electronic Submissions submission. You should submit two
Submit electronic comments in the copies total. One copy will include the
Amendment to Guidance for Industry:
following way: information you claim to be confidential
Use of Serological Tests To Reduce
• Federal eRulemaking Portal: http:// with a heading or cover note that states
the Risk of Transmission of
www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS
Trypanosoma cruzi Infection in Whole
instructions for submitting comments. CONFIDENTIAL INFORMATION.’’ The
Blood and Blood Components
Comments submitted electronically, Agency will review this copy, including
Intended for Transfusion; Draft
including attachments, to http:// the claimed confidential information, in
Guidance for Industry; Availability
www.regulations.gov will be posted to its consideration of comments. The
AGENCY: Food and Drug Administration, the docket unchanged. Because your second copy, which will have the
HHS. comment will be made public, you are claimed confidential information
ACTION: Notice of availability. solely responsible for ensuring that your redacted/blacked out, will be available
comment does not include any for public viewing and posted on http://
SUMMARY: The Food and Drug confidential information that you or a www.regulations.gov. Submit both
Administration (FDA or Agency) is third party may not wish to be posted, copies to the Division of Dockets
announcing the availability of a draft such as medical information, your or Management. If you do not wish your
document entitled ‘‘Amendment to anyone else’s Social Security number, or name and contact information to be
Guidance for Industry: Use of confidential business information, such made publicly available, you can
Serological Tests to Reduce the Risk of as a manufacturing process. Please note provide this information on the cover
Transmission of Trypanosoma cruzi that if you include your name, contact sheet and not in the body of your
Infection in Whole Blood and Blood information, or other information that comments and you must identify this
Components Intended for Transfusion; identifies you in the body of your information as ‘‘confidential.’’ Any
Draft Guidance for Industry.’’ The draft comments, that information will be information marked as ‘‘confidential’’
guidance document, when finalized, is posted on http://www.regulations.gov. will not be disclosed except in
intended to amend the document • If you want to submit a comment accordance with 21 CFR 10.20 and other
entitled ‘‘Guidance for Industry: Use of with confidential information that you applicable disclosure law. For more
Serological Tests to Reduce the Risk of do not wish to be made available to the information about FDA’s posting of
Transmission of Trypanosoma cruzi public, submit the comment as a comments to public dockets, see 80 FR
Infection in Whole Blood and Blood written/paper submission and in the 56469, September 18, 2015, or access
Components Intended for Transfusion’’ manner detailed (see ‘‘Written/Paper the information at: http://www.fda.gov/
dated December 2010 (2010 Chagas Submissions’’ and ‘‘Instructions’’). regulatoryinformation/dockets/
Guidance) by expanding the scope of Written/Paper Submissions default.htm.
the guidance to include the collection of Docket: For access to the docket to
Submit written/paper submissions as
blood and blood components for use in read background documents or the
follows:
manufacturing a product, including • Mail/Hand delivery/Courier (for electronic and written/paper comments
donations intended as a component of, written/paper submissions): Division of received, go to http://
or used to manufacture, a medical Dockets Management (HFA–305), Food www.regulations.gov and insert the
device; removing the recommendation and Drug Administration, 5630 Fishers docket number, found in brackets in the
to ask donors about a history of Chagas Lane, Rm. 1061, Rockville, MD 20852. heading of this document, into the
disease; and providing a • For written/paper comments ‘‘Search’’ box and follow the prompts
recommendation for a reentry algorithm submitted to the Division of Dockets and/or go to the Division of Dockets
for donors deferred on the basis of Management, FDA will post your Management, 5630 Fishers Lane, Rm.
screening test results for antibodies to comment, as well as any attachments, 1061, Rockville, MD 20852.
Trypanosoma cruzi (T. cruzi) or on the except for information submitted, Submit written requests for single
basis of answering ‘‘yes’’ to the Chagas marked and identified, as confidential, copies of the draft guidance to the Office
screening question. Further, the if submitted as detailed in of Communication, Outreach and
guidance is intended to notify blood ‘‘Instructions.’’ Development, Center for Biologics
establishments that collect blood and Instructions: All submissions received Evaluation and Research (CBER), Food
blood components that FDA has must include the Docket No. FDA– and Drug Administration, 10903 New
licensed a supplemental test for 2009–D–0137 for ‘‘Amendment to Hampshire Ave., Bldg. 71, Rm. 3128,
antibodies to T. cruzi and further testing Guidance for Industry: Use of Silver Spring, MD 20993–0002. Send
of donations found repeatedly reactive Serological Tests to Reduce the Risk of one self-addressed adhesive label to
to a screening test for T. cruzi is Transmission of Trypanosoma cruzi assist the office in processing your
therefore required. The draft guidance Infection in Whole Blood and Blood requests. The draft guidance may also be
does not apply to the collection of Components Intended for Transfusion; obtained by mail by calling CBER at 1–
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Source Plasma. Draft Guidance for Industry.’’ Received 800–835–4709 or 240–402–8010. See
DATES: Although you can comment on comments will be placed in the docket the SUPPLEMENTARY INFORMATION section
any guidance at any time (see 21 CFR and, except for those submitted as for electronic access to the draft
10.115(g)(5)), to ensure that the Agency ‘‘Confidential Submissions,’’ publicly guidance document.
considers your comment on this draft viewable at http://www.regulations.gov FOR FURTHER INFORMATION CONTACT:
guidance before it begins work on the or at the Division of Dockets Tami Belouin, Center for Biologics
final version of the guidance, submit Management between 9 a.m. and 4 p.m., Evaluation and Research, Food and
either electronic or written comments Monday through Friday. Drug Administration, 10903 New
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![Federal Register / Vol. 81, No. 218 / Thursday, November 10, 2016 / Notices 79035
Hampshire Ave., Bldg. 71, Rm. 7301, Reduce the Risk of Transmission of with the implementation of the Federal
Silver Spring, MD 20993–0002, 240– Trypanosoma cruzi Infection in Whole Health IT Strategic Plan, and in
402–7911. Blood and Blood Components Intended accordance with policies developed by
SUPPLEMENTARY INFORMATION: for Transfusion; Draft Guidance for the Health IT Policy Committee.
Industry.’’ It does not establish any 2016 Meeting Dates and Times
I. Background rights for any person and is not binding
FDA is announcing the availability of on FDA or the public. You can use an • December 6, 2016 from 9:30 a.m. to
a draft document entitled ‘‘Amendment alternative approach if it satisfies the 1:30 p.m./Eastern Time (replacing
to Guidance for Industry: Use of requirements of the applicable statutes the formerly announced November
Serological Tests to Reduce the Risk of and regulations. 2 and December 7 meetings)
Transmission of Trypanosoma cruzi Æ This will be a virtual Joint Health
Infection in Whole Blood and Blood II. Paperwork Reduction Act of 1995 IT Policy and Health IT Standards
Components Intended for Transfusion; This draft guidance refers to Committee meeting
Draft Guidance for Industry.’’ The draft previously approved collections of For meeting locations, web conference
guidance, when finalized, is intended to information found in FDA regulations. information, and the most up-to-date
amend the 2010 Chagas Guidance (75 These collections of information are information, please visit the calendar on
FR 75810, December 6, 2010) by subject to review by the Office of the ONC Web site, http://
expanding the scope of the guidance to Management and Budget (OMB) under www.healthit.gov/FACAS/calendar.
include the collection of blood and the Paperwork Reduction Act of 1995 Contact Person: Michelle Consolazio,
blood components for use in (44 U.S.C. 3501–3520). The collections email: michelle.consolazio@hhs.gov.
manufacturing a product, including of information in 21 CFR 601.12 have Please email Michelle Consolazio for the
donations intended as a component of, been approved under OMB control most current information about
or used to manufacture, a medical number 0910–0338; and the collections meetings. A notice in the Federal
device; removing the recommendation of information in 21 CFR 610.40 and Register about last minute modifications
to ask donors about a history of Chagas 630.40 have been approved under OMB that impact a previously announced
disease; and providing a control numbers 0910–0116 and 0910– advisory committee meeting cannot
recommendation for a reentry algorithm 0795. always be published quickly enough to
for donors deferred on the basis of provide timely notice.
screening test results for antibodies to T. III. Electronic Access Agenda: The committee will hear
cruzi or on the basis of answering ‘‘yes’’ Persons with access to the Internet reports from its workgroups/task forces
to the Chagas screening question. may obtain the draft guidance at either and updates from ONC and other federal
In the Federal Register of May 22, http://www.fda.gov/BiologicsBlood agencies. ONC intends to make
2015 (80 FR 29842), FDA published the Vaccines/Guidance background material available to the
final rule entitled ‘‘Requirements for ComplianceRegulatoryInformation/ public no later than 24 hours prior to
Blood and Blood Components Intended Guidances/default.htm or http:// the meeting start time. If ONC is unable
for Transfusion or for Further www.regulations.gov. to post the background material on its
Manufacturing Use.’’ The final rule Web site prior to the meeting, it will be
Dated: November 3, 2016.
became effective May 23, 2016. The made publicly available at the location
Leslie Kux, of the advisory committee meeting, and
draft guidance is intended to notify
blood establishments that collect blood Associate Commissioner for Policy. the background material will be posted
and blood components that T. cruzi is [FR Doc. 2016–27107 Filed 11–9–16; 8:45 am] on ONC’s Web site after the meeting, at
defined as a relevant transfusion- BILLING CODE 4164–01–P http://www.healthit.gov/facas/health-it-
transmitted infection in 21 CFR standards-committee.
630.3(h)(1), subject to the testing Procedure: Interested persons may
requirements in 21 CFR 610.40, the DEPARTMENT OF HEALTH AND present data, information, or views,
donor deferral practices in 21 CFR HUMAN SERVICES orally or in writing, on issues pending
610.41, and the donor notification before the Committee. Written
requirements in 21 CFR 630.40 under Health IT Standards Committee submissions may be made to the contact
the final rule. In addition, the draft Advisory Meeting; Notice of Meeting person prior to the meeting date. Oral
guidance is intended to notify blood AGENCY: Office of the National comments from the public will be
establishments that collect blood and Coordinator for Health Information scheduled prior to the lunch break and
blood components that FDA has Technology, HHS. at the conclusion of each meeting. Time
licensed a supplemental test for ACTION: Notice of meeting allotted for each presentation will be
antibodies to T. cruzi and further testing limited to three minutes. If the number
of donations found repeatedly reactive This notice announces updated dates of speakers requesting to comment is
to a screening test for T. cruzi is for meetings of a public advisory greater than can be reasonably
therefore required under 21 CFR committee of the Office of the National accommodated during the scheduled
610.40(e). The draft guidance does not Coordinator for Health Information open public session, ONC will take
apply to the collection of Source Technology (ONC). These meetings are written comments after the meeting.
Plasma. All other recommendations in open to the public. Persons attending ONC’s advisory
Name of Committee: Health IT committee meetings are advised that the
asabaliauskas on DSK3SPTVN1PROD with NOTICES
the 2010 Chagas Guidance would
remain unchanged. Standards Committee. agency is not responsible for providing
This draft guidance is being issued General Function of the Committee: wireless access or access to electrical
consistent with FDA’s good guidance To provide recommendations to the outlets.
practices regulation (21 CFR 10.115). National Coordinator on standards, ONC welcomes the attendance of the
The draft guidance, when finalized, will implementation specifications, and public at its advisory committee
represent the current thinking of FDA certification criteria for the electronic meetings. Seating is limited at the
on ‘‘Amendment to Guidance for exchange and use of health information location, and ONC will make every
Industry: Use of Serological Tests to for purposes of adoption, consistent effort to accommodate persons with
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Document Created: 2016-11-10 01:43:48
Document Modified: 2016-11-10 01:43:48
| 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 February 8, 2017. | |
| Contact | Tami Belouin, 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 | 81 FR 79034 |
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