83 FR 48448 - Recommendations for Requalification of Blood Donors Deferred Because of Reactive Test Results for Antibodies to Human T-Lymphotropic Virus Types I and II; Draft Guidance for Industry; Availability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 | 48448-48449 | |
| FR Document | 2018-20775 |
[Federal Register Volume 83, Number 186 (Tuesday, September 25, 2018)] [Notices] [Pages 48448-48449] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-20775] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-3324] Recommendations for Requalification of Blood Donors Deferred Because of Reactive Test Results for Antibodies to Human T-Lymphotropic Virus Types I and II; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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 ``Recommendations for Requalification of Blood Donors Deferred Because of Reactive Test Results for Antibodies to Human T-Lymphotropic Virus Types I and II (anti-HTLV-I/II); Draft Guidance for Industry.'' The draft guidance document provides blood establishments that collect Whole Blood and blood components with recommendations for a requalification method for deferred donors, based on a determination that their previous reactive test results for anti-HTLV-I/II were falsely positive. DATES: Submit either electronic or written comments on the draft guidance by December 24, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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-3324 for ``Recommendations for Requalification of Blood Donors Deferred Because of Reactive Test Results for Antibodies to Human T-Lymphotropic Virus Types I and II (anti-HTLV-I/II); Draft Guidance for Industry.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' will be 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 [[Page 48449]] 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: Gretchen Opper, 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 ``Recommendations for Requalification of Blood Donors Deferred Because of Reactive Test Results for Antibodies to Human T-Lymphotropic Virus Types I and II (anti-HTLV-I/II); Draft Guidance for Industry.'' The draft guidance provides blood establishments that collect Whole Blood and blood components with recommendations for a requalification method under 21 CFR 610.41(b) for deferred donors, based on a determination that their previous reactive test results for anti-HTLV-I/II were falsely positive. Blood establishments are not required to test Source Plasma for HLTV I/II (21 CFR 610.40 (a)(2)(ii)). Therefore, this guidance does not apply to the collection of Source Plasma. 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 recommendations for requalification of blood donors deferred because of reactive test results for antibodies to human T-lymphotropic virus types I and II (anti-HTLV-I/II). 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 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 and Form FDA 356h have been approved under OMB control number 0910-0338, and the collections of information in 21 CFR parts 610 and 606 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. 2018-20775 Filed 9-24-18; 8:45 am] BILLING CODE 4164-01-P
![48448 Federal Register / Vol. 83, No. 186 / Tuesday, September 25, 2018 / Notices
redacted/blacked out, will be available DEPARTMENT OF HEALTH AND do not wish to be made available to the
for public viewing and posted on HUMAN SERVICES public, submit the comment as a
https://www.regulations.gov. Submit written/paper submission and in the
both copies to the Dockets Management Food and Drug Administration manner detailed (see ‘‘Written/Paper
Staff. If you do not wish your name and [Docket No. FDA–2018–D–3324] Submissions’’ and ‘‘Instructions’’).
contact information to be made publicly Written/Paper Submissions
available, you can provide this Recommendations for Requalification
of Blood Donors Deferred Because of Submit written/paper submissions as
information on the cover sheet and not
Reactive Test Results for Antibodies to follows:
in the body of your comments and you • Mail/Hand Delivery/Courier (for
must identify this information as Human T-Lymphotropic Virus Types I
and II; Draft Guidance for Industry; written/paper submissions): Dockets
‘‘confidential’’. Any information marked Management Staff (HFA–305), Food and
as ‘‘confidential’’ will not be disclosed Availability
Drug Administration, 5630 Fishers
except in accordance with 21 CFR 10.20 AGENCY: Food and Drug Administration, Lane, Rm. 1061, Rockville, MD 20852.
and other applicable disclosure law. For HHS. • For written/paper comments
more information about FDA’s posting ACTION: Notice of availability. submitted to the Dockets Management
of comments to public dockets, see 80 Staff, FDA will post your comment as
FR 56469, September 18, 2015, or access SUMMARY: The Food and Drug well as any attachments, except for
the information at: https://www.gpo.gov/ Administration (FDA or Agency) is information submitted, marked, and
fdsys/pkg/FR-2015-09-18/pdf/2015- announcing the availability of a draft identified as confidential, if submitted
23389.pdf. document entitled ‘‘Recommendations as detailed in ‘‘Instructions.’’
for Requalification of Blood Donors Instructions: All submissions received
Docket: For access to the docket to Deferred Because of Reactive Test must include the Docket No. FDA–
read background documents or the Results for Antibodies to Human T- 2018–D–3324 for ‘‘Recommendations
electronic and written/paper comments Lymphotropic Virus Types I and II (anti- for Requalification of Blood Donors
received, go to https:// HTLV–I/II); Draft Guidance for Deferred Because of Reactive Test
www.regulations.gov and insert the Industry.’’ The draft guidance document Results for Antibodies to Human T-
docket number, found in brackets in the provides blood establishments that Lymphotropic Virus Types I and II (anti-
heading of this document, into the collect Whole Blood and blood HTLV–I/II); Draft Guidance for
‘‘Search’’ box and follow the prompts components with recommendations for Industry.’’ Received comments will be
and/or go to the Dockets Management a requalification method for deferred placed in the docket and, except for
Staff, 5630 Fishers Lane, Rm. 1061, donors, based on a determination that those submitted as ‘‘Confidential
Rockville, MD 20852. their previous reactive test results for Submissions,’’ will be publicly viewable
anti-HTLV–I/II were falsely positive. at https://www.regulations.gov or at the
FOR FURTHER INFORMATION CONTACT: Dockets Management Staff between 9
DATES: Submit either electronic or
Victoria Wagman, Center for Devices written comments on the draft guidance a.m. and 4 p.m., Monday through
and Radiological Health, Food and Drug by December 24, 2018 to ensure that the Friday.
Administration, 10903 New Hampshire Agency considers your comment on this • Confidential Submissions—To
Ave., Bldg. 66, Rm. 5562, Silver Spring, draft guidance before it begins work on submit a comment with confidential
MD 20993, 301–796–6581, the final version of the guidance. information that you do not wish to be
Victoria.Wagman@fda.hhs.gov. ADDRESSES: You may submit comments made publicly available, submit your
on any guidance at any time as follows: comments only as a written/paper
SUPPLEMENTARY INFORMATION:
submission. You should submit two
I. Background Electronic Submissions copies total. One copy will include the
Submit electronic comments in the information you claim to be confidential
In the Federal Register of February following way: with a heading or cover note that states
16, 2018 (83 FR 7052), FDA published • Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS
a notice announcing the public meeting https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
entitled ‘‘Pediatric Medical Device instructions for submitting comments. Agency will review this copy, including
Development’’ with a 30-day comment Comments submitted electronically, the claimed confidential information, in
period post the meeting to request including attachments, to https:// its consideration of comments. The
comments. The public meeting was held www.regulations.gov will be posted to second copy, which will have the
on August 13 and 14, 2018. FDA is the docket unchanged. Because your claimed confidential information
reopening the comment period for the comment will be made public, you are redacted/blacked out, will be available
public meeting until November 26, solely responsible for ensuring that your for public viewing and posted on
2018. The Agency believes that this will comment does not include any https://www.regulations.gov. Submit
allow adequate time for interested confidential information that you or a both copies to the Dockets Management
persons to submit comments without third party may not wish to be posted, Staff. If you do not wish your name and
significantly delaying action by the such as medical information, your or contact information to be made publicly
Agency. anyone else’s Social Security number, or available, you can provide this
confidential business information, such information on the cover sheet and not
Dated: September 19, 2018. as a manufacturing process. Please note in the body of your comments, and you
daltland on DSKBBV9HB2PROD with NOTICES
Leslie Kux, that if you include your name, contact must identify this information as
Associate Commissioner for Policy. information, or other information that ‘‘confidential.’’ Any information marked
[FR Doc. 2018–20795 Filed 9–24–18; 8:45 am] identifies you in the body of your as ‘‘confidential’’ will not be disclosed
BILLING CODE 4164–01–P
comments, that information will be except in accordance with 21 CFR 10.20
posted on https://www.regulations.gov. and other applicable disclosure law. For
• If you want to submit a comment more information about FDA’s posting
with confidential information that you of comments to public dockets, see 80
VerDate Sep<11>2014 17:40 Sep 24, 2018 Jkt 244001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\25SEN1.SGM 25SEN1](https://thefederalregister.org/doc/83_FR_48634/page/1.svg)
![Federal Register / Vol. 83, No. 186 / Tuesday, September 25, 2018 / Notices 48449
FR 56469, September 18, 2015, or access This draft guidance is being issued following summary of a proposed
the information at: https://www.gpo.gov/ consistent with FDA’s good guidance collection for public comment.
fdsys/pkg/FR-2015-09-18/pdf/2015- practices regulation (21 CFR 10.115). DATES: Comments on the ICR must be
23389.pdf. The draft guidance, when finalized, will received on or before October 25, 2018.
Docket: For access to the docket to represent the current thinking of FDA
read background documents or the on recommendations for requalification ADDRESSES: Submit your comments to
electronic and written/paper comments of blood donors deferred because of OIRA_submission@omb.eop.gov or via
received, go to https:// reactive test results for antibodies to facsimile to (202) 395–5806.
www.regulations.gov and insert the human T-lymphotropic virus types I FOR FURTHER INFORMATION CONTACT:
docket number, found in brackets in the and II (anti-HTLV–I/II). It does not Sherrette Funn, Sherrette.Funn@hhs.gov
heading of this document, into the establish any rights for any person and or (202) 795–7714. When submitting
‘‘Search’’ box and follow the prompts is not binding on FDA or the public. comments or requesting information,
and/or go to the Dockets Management You can use an alternative approach if please include the document identifier
Staff, 5630 Fishers Lane, Rm. 1061, it satisfies the requirements of the 4040–0016–30D and project title for
Rockville, MD 20852. applicable statutes and regulations. This reference.
You may submit comments on any guidance is not subject to Executive
guidance at any time (see 21 CFR Order 12866. SUPPLEMENTARY INFORMATION: Interested
10.115(g)(5)). persons are invited to send comments
Submit written requests for single II. Paperwork Reduction Act of 1995 regarding this burden estimate or any
copies of the draft guidance to the Office This guidance refers to previously other aspect of this collection of
of Communication, Outreach and approved collections of information information, including any of the
Development, Center for Biologics found in FDA regulations. These following subjects: (1) The necessity and
Evaluation and Research (CBER), Food collections of information are subject to utility of the proposed information
and Drug Administration, 10903 New review by the Office of Management and collection for the proper performance of
Hampshire Ave., Bldg. 71, Rm. 3128, Budget (OMB) under the Paperwork the agency’s functions; (2) the accuracy
Silver Spring, MD 20993–0002. Send Reduction Act of 1995 (44 U.S.C. 3501– of the estimated burden; (3) ways to
one self-addressed adhesive label to 3520). The collections of information in enhance the quality, utility, and clarity
assist the office in processing your 21 CFR part 601 and Form FDA 356h of the information to be collected; and
requests. The draft guidance may also be have been approved under OMB control (4) the use of automated collection
obtained by mail by calling CBER at 1– number 0910–0338, and the collections techniques or other forms of information
800–835–4709 or 240–402–8010. See of information in 21 CFR parts 610 and technology to minimize the information
the SUPPLEMENTARY INFORMATION section 606 have been approved under OMB collection burden.
for electronic access to the draft control number 0910–0116. Title of the Collections:
guidance document. INSTRUCTIONS FOR THE SF–429 Real
FOR FURTHER INFORMATION CONTACT:
III. Electronic Access
Property Status Report, SF–429 Real
Gretchen Opper, Center for Biologics Persons with access to the internet Property Status Report (Cover Page),
Evaluation and Research, Food and may obtain the draft guidance at either SF–429–A Real Property Status Report
Drug Administration, 10903 New https://www.fda.gov/BiologicsBlood ATTACHMENT A (General Reporting),
Hampshire Ave., Bldg. 71, Rm. 7301, Vaccines/GuidanceCompliance SF–429–B Real Property Status Report
Silver Spring, MD 20993–0002, 240– RegulatoryInformation/Guidances/ ATTACHMENT B (Request to Acquire,
402–7911. default.htm or https:// Improve or Furnish), and SF–429–C
SUPPLEMENTARY INFORMATION: www.regulations.gov. Real Property Status Report
I. Background Dated: September 18, 2018. ATTACHMENT C (Disposition or
Leslie Kux, Encumbrance Request) forms.
FDA is announcing the availability of
Associate Commissioner for Policy. Type of Collection: Extension.
a draft document entitled
[FR Doc. 2018–20775 Filed 9–24–18; 8:45 am] OMB No.: 4040–0016.
‘‘Recommendations for Requalification
of Blood Donors Deferred Because of BILLING CODE 4164–01–P Abstract: INSTRUCTIONS FOR THE
Reactive Test Results for Antibodies to SF–429 Real Property Status Report,
Human T-Lymphotropic Virus Types I SF–429 Real Property Status Report
DEPARTMENT OF HEALTH AND
and II (anti-HTLV–I/II); Draft Guidance (Cover Page), SF–429–A Real Property
HUMAN SERVICES
for Industry.’’ The draft guidance Status Report ATTACHMENT A
provides blood establishments that [Document Identifier: OS–4040–0016] (General Reporting), SF–429–B Real
collect Whole Blood and blood Property Status Report ATTACHMENT
components with recommendations for Agency Information Collection B (Request to Acquire, Improve or
a requalification method under 21 CFR Request. 30-Day Public Comment Furnish), and SF–429–C Real Property
610.41(b) for deferred donors, based on Request Status Report ATTACHMENT C
a determination that their previous AGENCY: Office of the Secretary, HHS. (Disposition or Encumbrance Request)
reactive test results for anti-HTLV–I/II ACTION: Notice. forms are OMB-approved collections
were falsely positive. Blood (4040–0016). These information
establishments are not required to test SUMMARY: In compliance with the collections are used by grant awardees
Source Plasma for HLTV I/II (21 CFR requirement of the Paperwork to report on their grant award . The ICs
daltland on DSKBBV9HB2PROD with NOTICES
610.40 (a)(2)(ii)). Therefore, this Reduction Act of 1995, the Office of the expire on January 31, 2019. We are
guidance does not apply to the Secretary (OS), Department of Health requesting a three-year clearance of
collection of Source Plasma. and Human Services, is publishing the these collections.
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Document Created: 2018-09-25 00:22:27
Document Modified: 2018-09-25 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 | 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 | Gretchen Opper, 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 48448 |
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