82 FR 57601 - Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Blood and Blood Components; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 233 (December 6, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 233 (December 6, 2017)
| Page Range | 57601-57603 | |
| FR Document | 2017-26226 |
[Federal Register Volume 82, Number 233 (Wednesday, December 6, 2017)] [Notices] [Pages 57601-57603] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-26226] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0137] Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Blood and Blood Components; 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 document entitled ``Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Blood and Blood Components; Guidance for Industry.'' The guidance document provides recommendations to blood collection establishments regarding the use of serological tests to reduce the risk of transmission of Trypanosoma cruzi (T. cruzi) infection in blood and blood components. The recommendations apply to the collection of blood and blood components, except Source Plasma, for transfusion or for use in manufacturing a product, including donations intended as a component of, or used to manufacture, a medical device. The guidance announced in this notice supersedes the guidance 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Blood and Blood Components Intended for Transfusion'' dated December 2010 (2010 Chagas Guidance) and finalizes the draft guidance entitled ``Amendment to `Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion'; Draft Guidance for Industry'' dated November 2016 (2016 Draft Chagas Guidance). The guidance incorporates recommendations for blood donor testing, deferral, and donor reentry from the 2016 Draft Chagas Guidance. DATES: The announcement of the guidance is published in the Federal Register on December 6, 2017. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time 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 [[Page 57602]] 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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, 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 ``Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Blood and Blood Components; Guidance for Industry.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 Dockets Management Staff. 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.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. 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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). 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. FOR FURTHER INFORMATION 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. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a document entitled ``Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Blood and Blood Components; Guidance for Industry.'' The guidance document addresses the use of serological tests to reduce the risk of transmission of T. cruzi infection in blood and blood components. The recommendations apply to the collection of blood and blood components, except Source Plasma, for transfusion or for use in manufacturing a product, including donations intended as a component of, or used to manufacture, a medical device. The guidance incorporates recommendations for blood donor testing, deferral, notification, and donor reentry from the 2016 Draft Chagas Guidance. The 2016 Draft Chagas Guidance amended the 2010 Chagas Guidance by (1) 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; (2) removing the recommendation to ask donors about a history of Chagas disease; and (3) providing a recommendation for a reentry algorithm for certain 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. The 2016 Draft Chagas Guidance also provided notice that FDA had 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). In the Federal Register of December 6, 2010 (75 FR 75810), FDA announced the availability of the guidance 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. In the Federal Register of November, 10, 2016 (81 FR 79034), FDA announced the availability of the draft guidance 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'' dated November 2016. FDA received two comments on the 2016 Draft Chagas Guidance and those comments were considered as the guidance was finalized. The guidance announced in this notice supersedes the 2010 Chagas Guidance and finalizes the 2016 Draft Chagas Guidance. This 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 Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Blood and Blood Components.'' 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. This guidance is not subject to Executive Order 12866. [[Page 57603]] II. Paperwork Reduction Act of 1995 This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). The guidance refers to the following collections of information: (1) Establishments notify consignees of all previously collected in-date blood and blood components from a donor that tests repeatedly reactive by a licensed test for T. cruzi antibody to quarantine and return the blood and blood components to the establishments or to destroy them; (2) establishments notify consignees of all previously distributed blood and blood components collected from such a donor during the lookback period; and (3) if such blood components were transfused, consignees notify the recipient's physician of record of a possible increased risk of T. cruzi infection. These collections of information have been approved under OMB control number 0910-0681. This guidance also refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR part 601 have been approved under OMB control number 0910-0338; and the collections of information in 21 CFR parts 606, 610, and 630 have been approved under OMB control numbers 0910- 0116 and 0910-0795. III. Electronic Access Persons with access to the internet may obtain the guidance at either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Dated: November 30, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-26226 Filed 12-5-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 233 / Wednesday, December 6, 2017 / Notices 57601
OMB control number 9000–0144. Select adjusted to reflect that the information announcing the availability of a
the link ‘‘Comment Now’’ that required by the clause at 52.232–33, document entitled ‘‘Use of Serological
corresponds with ‘‘Information Payment by Electronic Funds Transfer— Tests to Reduce the Risk of
Collection 9000–0144, Payment by System for Award Management, is Transmission of Trypanosoma cruzi
Electronic Funds Transfer’’. Follow the already covered by OMB Control Infection in Blood and Blood
instructions provided on the screen. Number 9000–0159, System for Award Components; Guidance for Industry.’’
Please include your name, company Management Registration (SAM). The guidance document provides
name (if any), and ‘‘Information recommendations to blood collection
B. Annual Reporting Burden
Collection 9000–0144, Payment by establishments regarding the use of
Electronic Funds Transfer’’, on your Respondents: 3,761. serological tests to reduce the risk of
attached document. Responses per Respondent: 1. transmission of Trypanosoma cruzi (T.
• Mail: General Services Annual Responses: 3,761. cruzi) infection in blood and blood
Administration, Regulatory Secretariat Hours per Response: 0.5. components. The recommendations
Division (MVCB), 1800 F Street NW., Total Burden Hours: 1,881.
apply to the collection of blood and
Washington, DC 20405. ATTN: Ms. C. Public Comments blood components, except Source
Mandell/IC 9000–0144, Payment by Public comments are particularly Plasma, for transfusion or for use in
Electronic Funds Transfer. invited on: Whether this collection of manufacturing a product, including
Instructions: Please submit comments information is necessary for the proper donations intended as a component of,
only and cite Information Collection performance of functions of the FAR, or used to manufacture, a medical
9000–0144, Payment by Electronic including whether the information will device. The guidance announced in this
Funds Transfer, in all correspondence have practical utility; the accuracy of notice supersedes the guidance entitled
related to this collection. Comments the estimate of the burden of the ‘‘Guidance for Industry: Use of
received generally will be posted information collection; ways to enhance Serological Tests to Reduce the Risk of
without change to http:// the quality, utility, and clarity of the Transmission of Trypanosoma cruzi
www.regulations.gov, including any information to be collected; and ways to Infection in Whole Blood and Blood
personal and/or business confidential minimize the burden of the information Components Intended for Transfusion’’
information provided. To confirm collection on respondents, including the dated December 2010 (2010 Chagas
receipt of your comment(s), please use of automated collection techniques Guidance) and finalizes the draft
check www.regulations.gov, or other forms of information guidance entitled ‘‘Amendment to
approximately two to three days after technology. ‘Guidance for Industry: Use of
submission to verify posting (except Obtaining Copies of Proposals: Serological Tests to Reduce the Risk of
allow 30 days for posting of comments Requesters may obtain a copy of the Transmission of Trypanosoma cruzi
submitted by mail). information collection documents from Infection in Whole Blood and Blood
FOR FURTHER INFORMATION CONTACT: Ms. the General Services Administration, Components Intended for Transfusion’;
Zenaida Delgado, Procurement Analyst, Regulatory Secretariat Division (MVCB), Draft Guidance for Industry’’ dated
via telephone 202–969–7207 or via 1800 F Street NW., Washington, DC November 2016 (2016 Draft Chagas
email to zenaida.delgado@gsa.gov. 20405, telephone 202–501–4755. Please Guidance). The guidance incorporates
SUPPLEMENTARY INFORMATION: cite OMB Control No. 9000–0144, recommendations for blood donor
Payment by Electronic Funds Transfer, testing, deferral, and donor reentry from
A. Purpose the 2016 Draft Chagas Guidance.
in all correspondence.
The FAR requires certain information DATES: The announcement of the
Dated: December 1, 2017.
to be provided by contractors which guidance is published in the Federal
Lorin S. Curit,
would enable the Government to make Register on December 6, 2017.
payments under the contract by Director, Federal Acquisition Policy Division,
ADDRESSES: You may submit either
Office of Government-wide Acquisition
electronic funds transfer (EFT). The Policy, Office of Acquisition Policy, Office electronic or written comments on
information necessary to make the EFT of Government-wide Policy. Agency guidances at any time as
transaction is specified in clause [FR Doc. 2017–26255 Filed 12–5–17; 8:45 am] follows:
52.232–33, Payment by Electronic
Funds Transfer—System for Award
BILLING CODE 6820–EP–P Electronic Submissions
Management, which the contractor is Submit electronic comments in the
required to provide prior to award, and following way:
clause 52.232–34, Payment by DEPARTMENT OF HEALTH AND • Federal eRulemaking Portal:
Electronic Funds Transfer—Other than HUMAN SERVICES https://www.regulations.gov. Follow the
System for Award Management, which Food and Drug Administration instructions for submitting comments.
requires EFT information to be provided Comments submitted electronically,
as specified by the agency to enable [Docket No. FDA–2009–D–0137] including attachments, to https://
payment by EFT. This collection of www.regulations.gov will be posted to
information is mostly imposed on Use of Serological Tests to Reduce the the docket unchanged. Because your
contractors upon award of each Risk of Transmission of Trypanosoma comment will be made public, you are
contract. Less frequent collection would cruzi Infection in Blood and Blood solely responsible for ensuring that your
not facilitate contract payment by EFT Components; Guidance for Industry; comment does not include any
daltland on DSKBBV9HB2PROD with NOTICES
as the standard method of payment Availability confidential information that you or a
under Government contracts. AGENCY: Food and Drug Administration, third party may not wish to be posted,
DoD, GSA and NASA analyzed the FY HHS. such as medical information, your or
2016 data from the Federal Procurement ACTION: Notice of availability. anyone else’s Social Security number, or
Data System (FPDS) to develop the confidential business information, such
estimated burden hours for this SUMMARY: The Food and Drug as a manufacturing process. Please note
information collection. The burden was Administration (FDA or Agency) is that if you include your name, contact
VerDate Sep<11>2014 18:07 Dec 05, 2017 Jkt 244001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\FR\FM\06DEN1.SGM 06DEN1](https://thefederalregister.org/doc/82_FR_57834/page/1.svg)
![Federal Register / Vol. 82, No. 233 / Wednesday, December 6, 2017 / Notices 57603
II. Paperwork Reduction Act of 1995 The meeting will be open to the Dated: November 30, 2017.
This guidance contains information public as indicated below, with Sylvia L. Neal,
collection provisions that are subject to attendance limited to space available. Program Analyst, Office of Federal Advisory
review by the Office of Management and Individuals who plan to attend and Committee Policy.
Budget (OMB) under the Paperwork need special assistance, such as sign [FR Doc. 2017–26209 Filed 12–5–17; 8:45 am]
Reduction Act of 1995 (PRA) (44 U.S.C. language interpretation or other
BILLING CODE 4140–01–P
3501–3520). The guidance refers to the reasonable accommodations, should
following collections of information: (1) notify the Contact Person listed below
Establishments notify consignees of all in advance of the meeting. DEPARTMENT OF HEALTH AND
previously collected in-date blood and The meeting will be closed to the HUMAN SERVICES
blood components from a donor that public in accordance with the
tests repeatedly reactive by a licensed provisions set forth in sections National Institutes of Health
test for T. cruzi antibody to quarantine 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
and return the blood and blood as amended. The grant applications and National Institute of Neurological
components to the establishments or to the discussions could disclose Disorders and Stroke; Notice of Closed
destroy them; (2) establishments notify confidential trade secrets or commercial Meeting
consignees of all previously distributed property such as patentable materials,
blood and blood components collected and personal information concerning Pursuant to section 10(d) of the
from such a donor during the lookback individuals associated with the grant Federal Advisory Committee Act, as
period; and (3) if such blood applications, the disclosure of which amended, notice is hereby given of a
components were transfused, would constitute a clearly unwarranted meeting of the Board of Scientific
consignees notify the recipient’s invasion of personal privacy. Counselors, National Institute of
physician of record of a possible Neurological Disorders and Stroke.
Name of Committee: National Advisory
increased risk of T. cruzi infection. Neurological Disorders and Stroke Council.
These collections of information have The meeting will be closed to the
Date: February 1, 2018. public as indicated below in accordance
been approved under OMB control Open: February 1, 2018, 8:00 a.m. to 3:00
number 0910–0681. with the provisions set forth in sections
p.m.
This guidance also refers to Agenda: Report by the Director, NINDS;
552b(c)(6), Title 5 U.S.C., as amended
previously approved collections of Report by the Director, Division of for the review, discussion, and
information found in FDA regulations. Extramural Activities; and Administrative evaluation of individual intramural
These collections of information are and Program Developments. programs and projects conducted by the
subject to review by OMB under the Place: National Institutes of Health, National Institute of Neurological
PRA. The collections of information in Neuroscience Center, 6001 Executive Disorders and Stroke, including
21 CFR part 601 have been approved Boulevard, Rockville, MD 20852. consideration of personnel
Closed: February 1, 2018, 3:00 p.m. to 5:00
under OMB control number 0910–0338; qualifications and performance, and the
p.m.
and the collections of information in 21 Agenda: To review and evaluate grant competence of individual investigators,
CFR parts 606, 610, and 630 have been applications. the disclosure of which would
approved under OMB control numbers Place: National Institutes of Health, constitute a clearly unwarranted
0910–0116 and 0910–0795. Neuroscience Center, 6001 Executive invasion of personal privacy.
Boulevard, Rockville, MD 20852.
III. Electronic Access Contact Person: Robert Finkelstein, Ph.D., Name of Committee: Board of Scientific
Persons with access to the internet Director, Division of Extramural Activities, Counselors, National Institute of
may obtain the guidance at either National Institute of Neurological Disorders Neurological Disorders and Stroke.
https://www.fda.gov/BiologicsBlood and Stroke, NIH, 6001 Executive Blvd., Suite Date: January 28–30, 2018.
Vaccines/GuidanceCompliance 3309, MSC 9531, Bethesda, MD 20892, (301) Time: 6:00 p.m. to 12:30 p.m.
RegulatoryInformation/Guidances/ 496–9248. Agenda: To review and evaluate personal
default.htm or https:// Any interested person may file written qualifications and performance, and
www.regulations.gov. comments with the committee by forwarding competence of individual investigators.
the statement to the Contact Person listed on Place: Residence Inn Bethesda, 7335
Dated: November 30, 2017. this notice. The statement should include the Wisconsin Avenue, Bethesda, MD 20814.
Leslie Kux, name, address, telephone number and when Contact Person: Alan P. Koretsky, Ph.D.,
Associate Commissioner for Policy. applicable, the business or professional Scientific Director, Division of Intramural
affiliation of the interested person.
[FR Doc. 2017–26226 Filed 12–5–17; 8:45 am] Research, National Institute of Neurological
In the interest of security, NIH has
BILLING CODE 4164–01–P instituted stringent procedures for entrance Disorders and Stroke, NIH, 35 Convent Drive,
into Federal buildings. Visitors will be asked Room 6A 908, Bethesda, MD 20892, (301)
to show one form of identification (for 435–2232, koretskya@ninds.nih.gov.
DEPARTMENT OF HEALTH AND example, a government-issued photo ID, (Catalogue of Federal Domestic Assistance
HUMAN SERVICES driver’s license, or passport) and to state the Program Nos. 93.853, Clinical Research
purpose of their visit. Related to Neurological Disorders; 93.854,
National Institutes of Health Information is also available on the Biological Basis Research in the
Institute’s/Center’s home page: http:// Neurosciences, National Institutes of Health,
National Institute of Neurological www.ninds.nih.gov, where an agenda and
HHS).
daltland on DSKBBV9HB2PROD with NOTICES
Disorders and Stroke; Notice of any additional information for the meeting
Meeting will be posted when available. Dated: November 30, 2017.
(Catalogue of Federal Domestic Assistance Sylvia L. Neal,
Pursuant to section 10(d) of the Program Nos. 93.853, Clinical Research
Federal Advisory Committee Act, as Program Analyst, Office of Federal Advisory
Related to Neurological Disorders; 93.854,
amended, notice is hereby given of the Committee Policy.
Biological Basis Research in the
National Advisory Neurological Neurosciences, National Institutes of Health, [FR Doc. 2017–26210 Filed 12–5–17; 8:45 am]
Disorders and Stroke Council. HHS). BILLING CODE 4140–01–P
VerDate Sep<11>2014 18:07 Dec 05, 2017 Jkt 244001 PO 00000 Frm 00035 Fmt 4703 Sfmt 9990 E:\FR\FM\06DEN1.SGM 06DEN1](https://thefederalregister.org/doc/82_FR_57834/page/3.svg)
Document Created: 2017-12-06 00:22:27
Document Modified: 2017-12-06 00:22:27
| 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 | The announcement of the guidance is published in the Federal Register on December 6, 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 | 82 FR 57601 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR