83 FR 48446 - Further Testing of Donations That Are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 186 (September 25, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 186 (September 25, 2018)
| Page Range | 48446-48447 | |
| FR Document | 2018-20776 |
[Federal Register Volume 83, Number 186 (Tuesday, September 25, 2018)] [Notices] [Pages 48446-48447] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-20776] [[Page 48446]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-3197] Further Testing of Donations That Are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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 ``Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus; Draft Guidance for Industry.'' The draft guidance document provides blood establishments that collect Whole Blood and blood components, including Source Plasma, with recommendations for further testing of donations that are reactive on a licensed donor screening test for antibodies to hepatitis C virus (anti-HCV). The draft guidance also provides guidance to blood establishments on how to report the implementation of these recommendations. The draft guidance, when finalized, will update the recommendations related to the use of an appropriate multiantigen supplemental test contained in ``Guidance for Industry: `Lookback' for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV'' dated December 2010. DATES: Submit either electronic or written comments on the draft guidance by December 24, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance 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 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-2018-D-3197 for ``Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus; Draft 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 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: Stephen Ripley, 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 draft document entitled ``Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus; Draft Guidance for Industry.'' The draft guidance provides blood establishments that collect Whole Blood and blood components, including Source Plasma, with recommendations for further testing of donations that are reactive on a licensed donor screening test for anti- [[Page 48447]] HCV, as required under Sec. 610.40(e) (21 CFR 610.40(e)). The draft guidance also provides guidance to blood establishments on how to report the implementation of these recommendations. In accordance with Sec. 610.40(e), each donation, including autologous donations, found to be reactive by a donor screening test must be further tested using a licensed, approved, or cleared supplemental test, when available. If no such supplemental test is available, blood establishments must perform one or more licensed, approved, or cleared tests as adequate and appropriate to provide additional information concerning the reactive donor's infection status (Sec. 610.40(e)). The draft guidance provides recommendations for adequate and appropriate testing under Sec. 610.40(e), with the licensed HCV NAT (nucleic acid test) and anti-HCV donor screening tests that are currently available, to provide additional information concerning the anti-HCV reactive donor's infection status. The draft guidance, when finalized, will update the recommendations related to the use of an appropriate multiantigen supplemental test contained in ``Guidance for Industry: `Lookback' for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV'' dated December 2010. 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 further testing of donations that are reactive on a licensed donor screening test for antibodies to HCV. 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. 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 part 601 have been approved under OMB control number 0910-0338; and the collections of information in 21 CFR part 610 and 21 CFR 630.40 have been approved under OMB control number 0910-0116. III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Dated: September 18, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-20776 Filed 9-24-18; 8:45 am] BILLING CODE 4164-01-P
![48446 Federal Register / Vol. 83, No. 186 / Tuesday, September 25, 2018 / Notices
DEPARTMENT OF HEALTH AND comment does not include any Staff. If you do not wish your name and
HUMAN SERVICES confidential information that you or a contact information to be made publicly
third party may not wish to be posted, available, you can provide this
Food and Drug Administration such as medical information, your or information on the cover sheet and not
[Docket No. FDA–2018–D–3197] anyone else’s Social Security number, or in the body of your comments and you
confidential business information, such must identify this information as
Further Testing of Donations That Are as a manufacturing process. Please note ‘‘confidential.’’ Any information marked
Reactive on a Licensed Donor that if you include your name, contact as ‘‘confidential’’ will not be disclosed
Screening Test for Antibodies to information, or other information that except in accordance with 21 CFR 10.20
Hepatitis C Virus; Draft Guidance for identifies you in the body of your and other applicable disclosure law. For
Industry; Availability comments, that information will be more information about FDA’s posting
posted on https://www.regulations.gov. of comments to public dockets, see 80
AGENCY: Food and Drug Administration, • If you want to submit a comment FR 56469, September 18, 2015, or access
HHS. with confidential information that you the information at: https://www.gpo.gov/
ACTION: Notice of availability. do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015-
public, submit the comment as a 23389.pdf.
SUMMARY: The Food and Drug
written/paper submission and in the Docket: For access to the docket to
Administration (FDA or Agency) is
manner detailed (see ‘‘Written/Paper read background documents or the
announcing the availability of a draft
Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments
document entitled ‘‘Further Testing of
Donations that are Reactive on a Written/Paper Submissions received, go to https://
Licensed Donor Screening Test for www.regulations.gov and insert the
Submit written/paper submissions as docket number, found in brackets in the
Antibodies to Hepatitis C Virus; Draft follows: heading of this document, into the
Guidance for Industry.’’ The draft • Mail/Hand Delivery/Courier (for
guidance document provides blood ‘‘Search’’ box and follow the prompts
written/paper submissions): Dockets
establishments that collect Whole Blood and/or go to the Dockets Management
Management Staff (HFA–305), Food and
and blood components, including Staff, 5630 Fishers Lane, Rm. 1061,
Drug Administration, 5630 Fishers
Source Plasma, with recommendations Rockville, MD 20852.
Lane, Rm. 1061, Rockville, MD 20852.
for further testing of donations that are • For written/paper comments You may submit comments on any
reactive on a licensed donor screening submitted to the Dockets Management guidance at any time (see 21 CFR
test for antibodies to hepatitis C virus Staff, FDA will post your comment, as 10.115(g)(5)).
(anti-HCV). The draft guidance also well as any attachments, except for Submit written requests for single
provides guidance to blood information submitted, marked and copies of the draft guidance to the Office
establishments on how to report the identified, as confidential, if submitted of Communication, Outreach and
implementation of these as detailed in ‘‘Instructions.’’ Development, Center for Biologics
recommendations. The draft guidance, Instructions: All submissions received Evaluation and Research (CBER), Food
when finalized, will update the must include the Docket No. FDA– and Drug Administration, 10903 New
recommendations related to the use of 2018–D–3197 for ‘‘Further Testing of Hampshire Ave., Bldg. 71, Rm. 3128,
an appropriate multiantigen Donations that are Reactive on a Silver Spring, MD 20993–0002. Send
supplemental test contained in Licensed Donor Screening Test for one self-addressed adhesive label to
‘‘Guidance for Industry: ‘Lookback’ for Antibodies to Hepatitis C Virus; Draft assist the office in processing your
Hepatitis C Virus (HCV): Product Guidance for Industry.’’ Received requests. The draft guidance may also be
Quarantine, Consignee Notification, comments will be placed in the docket obtained by mail by calling CBER at 1–
Further Testing, Product Disposition, and, except for those submitted as 800–835–4709 or 240–402–8010. See
and Notification of Transfusion ‘‘Confidential Submissions,’’ publicly the SUPPLEMENTARY INFORMATION section
Recipients Based on Donor Test Results viewable at https://www.regulations.gov for electronic access to the draft
Indicating Infection with HCV’’ dated or at the Dockets Management Staff guidance document.
December 2010. between 9 a.m. and 4 p.m., Monday FOR FURTHER INFORMATION CONTACT:
DATES: Submit either electronic or through Friday. Stephen Ripley, Center for Biologics
written comments on the draft guidance • Confidential Submissions—To Evaluation and Research, Food and
by December 24, 2018 to ensure that the submit a comment with confidential Drug Administration, 10903 New
Agency considers your comment on this information that you do not wish to be Hampshire Ave., Bldg. 71, Rm. 7301,
draft guidance before it begins work on made publicly available, submit your Silver Spring, MD 20993–0002, 240–
the final version of the guidance. comments only as a written/paper 402–7911.
ADDRESSES: You may submit comments submission. You should submit two SUPPLEMENTARY INFORMATION:
on any guidance at any time as follows: copies total. One copy will include the
information you claim to be confidential I. Background
Electronic Submissions with a heading or cover note that states FDA is announcing the availability of
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS a draft document entitled ‘‘Further
following way: CONFIDENTIAL INFORMATION.’’ The Testing of Donations that are Reactive
• Federal eRulemaking Portal: Agency will review this copy, including on a Licensed Donor Screening Test for
https://www.regulations.gov. Follow the the claimed confidential information, in Antibodies to Hepatitis C Virus; Draft
daltland on DSKBBV9HB2PROD with NOTICES
instructions for submitting comments. its consideration of comments. The Guidance for Industry.’’ The draft
Comments submitted electronically, second copy, which will have the guidance provides blood establishments
including attachments, to https:// claimed confidential information that collect Whole Blood and blood
www.regulations.gov will be posted to redacted/blacked out, will be available components, including Source Plasma,
the docket unchanged. Because your for public viewing and posted on with recommendations for further
comment will be made public, you are https://www.regulations.gov. Submit testing of donations that are reactive on
solely responsible for ensuring that your both copies to the Dockets Management a licensed donor screening test for anti-
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![Federal Register / Vol. 83, No. 186 / Tuesday, September 25, 2018 / Notices 48447
HCV, as required under § 610.40(e) (21 21 CFR 630.40 have been approved including attachments, to https://
CFR 610.40(e)). The draft guidance also under OMB control number 0910–0116. www.regulations.gov will be posted to
provides guidance to blood the docket unchanged. Because your
III. Electronic Access
establishments on how to report the comment will be made public, you are
implementation of these Persons with access to the internet solely responsible for ensuring that your
recommendations. may obtain the draft guidance at either comment does not include any
In accordance with § 610.40(e), each https://www.fda.gov/Biologics confidential information that you or a
donation, including autologous BloodVaccines/GuidanceCompliance third party may not wish to be posted,
donations, found to be reactive by a RegulatoryInformation/Guidances/ such as medical information, your or
donor screening test must be further default.htm or https:// anyone else’s Social Security number, or
tested using a licensed, approved, or www.regulations.gov. confidential business information, such
cleared supplemental test, when Dated: September 18, 2018. as a manufacturing process. Please note
available. If no such supplemental test that if you include your name, contact
Leslie Kux,
is available, blood establishments must information, or other information that
Associate Commissioner for Policy.
perform one or more licensed, identifies you in the body of your
approved, or cleared tests as adequate [FR Doc. 2018–20776 Filed 9–24–18; 8:45 am]
comments, that information will be
and appropriate to provide additional BILLING CODE 4164–01–P posted on https://www.regulations.gov.
information concerning the reactive • If you want to submit a comment
donor’s infection status (§ 610.40(e)). with confidential information that you
The draft guidance provides DEPARTMENT OF HEALTH AND do not wish to be made available to the
recommendations for adequate and HUMAN SERVICES public, submit the comment as a
appropriate testing under § 610.40(e), written/paper submission and in the
Food and Drug Administration
with the licensed HCV NAT (nucleic manner detailed (see ‘‘Written/Paper
acid test) and anti-HCV donor screening [Docket No. FDA–2018–N–0404] Submissions’’ and ‘‘Instructions’’).
tests that are currently available, to
Pediatric Medical Device Development; Written/Paper Submissions
provide additional information
concerning the anti-HCV reactive Public Meeting; Request for Submit written/paper submissions as
donor’s infection status. The draft Comments; Reopening of Comment follows:
guidance, when finalized, will update Period • Mail/Hand delivery/Courier (for
the recommendations related to the use written/paper submissions): Dockets
AGENCY: Food and Drug Administration, Management Staff (HFA–305), Food and
of an appropriate multiantigen HHS.
supplemental test contained in Drug Administration, 5630 Fishers
ACTION: Notice; reopening of comment Lane, Rm. 1061, Rockville, MD 20852.
‘‘Guidance for Industry: ‘Lookback’ for
Hepatitis C Virus (HCV): Product period. • For written/paper comments
Quarantine, Consignee Notification, submitted to the Dockets Management
SUMMARY: The Food and Drug
Further Testing, Product Disposition, Staff, FDA will post your comment, as
Administration (FDA or Agency) is
and Notification of Transfusion well as any attachments, except for
reopening the comment period provided
Recipients Based on Donor Test Results information submitted, marked and
in the notice entitled ‘‘Pediatric Medical
Indicating Infection with HCV’’ dated identified, as confidential, if submitted
Device Development; Public Meeting;
December 2010. as detailed in ‘‘Instructions’’.
Request for Comments’’ that appeared in Instructions: All submissions received
This draft guidance is being issued the Federal Register on February 16,
consistent with FDA’s good guidance must include the Docket No. FDA–
2018. That notice announced the public 2018–N–0404 for ‘‘Pediatric Medical
practices regulation (21 CFR 10.115). meeting to be held on August 13 and 14,
The draft guidance, when finalized, will Device Development; Public Meeting;
2018, and requested comments by Request for Comments; Reopening of
represent the current thinking of FDA September 14, 2018. FDA is reopening
on further testing of donations that are Comment Period.’’ Received comments
the public meeting’s comment period will be placed in the docket and, except
reactive on a licensed donor screening until November 26, 2018. The Agency is
test for antibodies to HCV. It does not for those submitted as ‘‘Confidential
taking this action to allow interested Submissions,’’ publicly viewable at
establish any rights for any person and parties additional time to submit
is not binding on FDA or the public. https://www.regulations.gov or at the
comments. Dockets Management Staff between 9
You can use an alternative approach if
it satisfies the requirements of the DATES: FDA is reopening the comment a.m. and 4 p.m., Monday through
applicable statutes and regulations. This period for the public meeting ‘‘Pediatric Friday.
guidance is not subject to Executive Medical Device Development; Public • Confidential Submissions—To
Order 12866. Meeting; Request for Comments’’ submit a comment with confidential
published on February 16, 2018 (83 FR information that you do not wish to be
II. Paperwork Reduction Act of 1995 7052). Submit either electronic or made publicly available, submit your
This draft guidance refers to written comments on this meeting by comments only as a written/paper
previously approved collections of November 26, 2018. submission. You should submit two
information found in FDA regulations. ADDRESSES: You may submit comments copies total. One copy will include the
These collections of information are as follows: information you claim to be confidential
subject to review by the Office of with a heading or cover note that states
daltland on DSKBBV9HB2PROD with NOTICES
Management and Budget (OMB) under Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
the Paperwork Reduction Act of 1995 Submit electronic comments in the CONFIDENTIAL INFORMATION’’. The
(44 U.S.C. 3501–3520). The collections following way: Agency will review this copy, including
of information in 21 CFR part 601 have • Federal eRulemaking Portal: the claimed confidential information, in
been approved under OMB control https://www.regulations.gov. Follow the its consideration of comments. The
number 0910–0338; and the collections instructions for submitting comments. second copy, which will have the
of information in 21 CFR part 610 and Comments submitted electronically, claimed confidential information
VerDate Sep<11>2014 17:40 Sep 24, 2018 Jkt 244001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\25SEN1.SGM 25SEN1](https://thefederalregister.org/doc/83_FR_48632/page/2.svg)
Document Created: 2018-09-25 00:22:34
Document Modified: 2018-09-25 00:22:34
| 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 | Submit either electronic or written comments on the draft guidance by December 24, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Stephen Ripley, 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 | 83 FR 48446 |
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