83 FR 35657 - Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 145 (July 27, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 145 (July 27, 2018)
| Page Range | 35657-35658 | |
| FR Document | 2018-16030 |
[Federal Register Volume 83, Number 145 (Friday, July 27, 2018)] [Notices] [Pages 35657-35658] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-16030] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-2478] Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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of a draft document entitled ``Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis; Draft Guidance for Industry.'' The draft guidance document notifies blood establishments that collect blood and blood components that we have determined babesiosis to be a relevant transfusion-transmitted infection (RTTI) and provides recommendations for donor screening, donation testing, donor deferral, and product management to reduce the risk of transfusion-transmitted babesiosis (TTB). The recommendations contained in the guidance apply to the collection of blood and blood components, except Source Plasma. DATES: Submit either electronic or written comments on the draft guidance by September 25, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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-2478 for ``Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis; 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: Valerie A. Butler, 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 Reducing the Risk of Transfusion-Transmitted Babesiosis; Draft Guidance for Industry.'' The draft guidance document [[Page 35658]] notifies blood establishments that collect blood and blood components that we have determined babesiosis to be an RTTI under 21 CFR 630.3(h)(2) and provides recommendations for donor screening, donation testing, donor deferral, and product management to reduce the risk of TTB. The recommendations contained in the draft guidance document applies to the collection of blood and blood components, except 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 reducing the risk of transfusion-transmitted babesiosis. 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 have been approved under OMB control number 0910-0338, and the collections of information in 21 CFR part 606, 21 CFR 610.40(h), 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 http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Dated: July 20, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-16030 Filed 7-26-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices 35657
public. You can use an alternative instructions for submitting comments. second copy, which will have the
approach if it satisfies the requirements Comments submitted electronically, claimed confidential information
of the applicable statutes and including attachments, to https:// redacted/blacked out, will be available
regulations. This guidance is not subject www.regulations.gov will be posted to for public viewing and posted on
to Executive Order 12866. the docket unchanged. Because your https://www.regulations.gov. Submit
comment will be made public, you are both copies to the Dockets Management
II. Electronic Access solely responsible for ensuring that your Staff. If you do not wish your name and
Persons with access to the internet comment does not include any contact information to be made publicly
may obtain the guidance at either confidential information that you or a available, you can provide this
https://www.fda.gov/Orphan or https:// third party may not wish to be posted, information on the cover sheet and not
www.regulations.gov. such as medical information, your or in the body of your comments and you
Dated: July 23, 2018. anyone else’s Social Security number, or must identify this information as
Leslie Kux,
confidential business information, such ‘‘confidential.’’ Any information marked
as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed
Associate Commissioner for Policy.
that if you include your name, contact except in accordance with 21 CFR 10.20
[FR Doc. 2018–16027 Filed 7–26–18; 8:45 am]
information, or other information that and other applicable disclosure law. For
BILLING CODE 4164–01–P identifies you in the body of your more information about FDA’s posting
comments, that information will be of comments to public dockets, see 80
posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access
DEPARTMENT OF HEALTH AND • If you want to submit a comment
HUMAN SERVICES the information at: https://www.gpo.gov/
with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015-
do not wish to be made available to the 23389.pdf.
Food and Drug Administration
public, submit the comment as a Docket: For access to the docket to
[Docket No. FDA–2018–D–2478] written/paper submission and in the read background documents or the
manner detailed (see ‘‘Written/Paper electronic and written/paper comments
Recommendations for Reducing the Submissions’’ and ‘‘Instructions’’). received, go to https://
Risk of Transfusion-Transmitted
Written/Paper Submissions www.regulations.gov and insert the
Babesiosis; Draft Guidance for
docket number, found in brackets in the
Industry; Availability Submit written/paper submissions as
heading of this document, into the
follows:
AGENCY: Food and Drug Administration, ‘‘Search’’ box and follow the prompts
• Mail/Hand Delivery/Courier (for
HHS. and/or go to the Dockets Management
written/paper submissions): Dockets
ACTION: Notice of availability. Staff, 5630 Fishers Lane, Rm. 1061,
Management Staff (HFA–305), Food and
Rockville, MD 20852.
Drug Administration, 5630 Fishers
SUMMARY: The Food and Drug You may submit comments on any
Lane, Rm. 1061, Rockville, MD 20852.
Administration (FDA or Agency) is • For written/paper comments guidance at any time (see 21 CFR
announcing the availability of a draft submitted to the Dockets Management 10.115(g)(5)).
document entitled ‘‘Recommendations Staff, FDA will post your comment, as Submit written requests for single
for Reducing the Risk of Transfusion- well as any attachments, except for copies of the draft guidance to the Office
Transmitted Babesiosis; Draft Guidance information submitted, marked and of Communication, Outreach and
for Industry.’’ The draft guidance identified, as confidential, if submitted Development, Center for Biologics
document notifies blood establishments as detailed in ‘‘Instructions.’’ Evaluation and Research (CBER), Food
that collect blood and blood Instructions: All submissions received and Drug Administration, 10903 New
components that we have determined must include the Docket No. FDA– Hampshire Ave., Bldg. 71, Rm. 3128,
babesiosis to be a relevant transfusion- 2018–D–2478 for ‘‘Recommendations Silver Spring, MD 20993–0002. Send
transmitted infection (RTTI) and for Reducing the Risk of Transfusion- one self-addressed adhesive label to
provides recommendations for donor Transmitted Babesiosis; Draft Guidance assist the office in processing your
screening, donation testing, donor for Industry.’’ Received comments will requests. The draft guidance may also be
deferral, and product management to be placed in the docket and, except for obtained by mail by calling CBER at 1–
reduce the risk of transfusion- those submitted as ‘‘Confidential 800–835–4709 or 240–402–8010. See
transmitted babesiosis (TTB). The Submissions,’’ publicly viewable at the SUPPLEMENTARY INFORMATION section
recommendations contained in the https://www.regulations.gov or at the for electronic access to the draft
guidance apply to the collection of Dockets Management Staff between 9 guidance document.
blood and blood components, except a.m. and 4 p.m., Monday through FOR FURTHER INFORMATION CONTACT:
Source Plasma. Friday. Valerie A. Butler, Center for Biologics
DATES: Submit either electronic or • Confidential Submissions—To Evaluation and Research, Food and
written comments on the draft guidance submit a comment with confidential Drug Administration, 10903 New
by September 25, 2018 to ensure that information that you do not wish to be Hampshire Ave., Bldg. 71, Rm. 7301,
the Agency considers your comment on made publicly available, submit your Silver Spring, MD 20993–0002, 240–
this draft guidance before it begins work comments only as a written/paper 402–7911.
on the final version of the guidance. submission. You should submit two SUPPLEMENTARY INFORMATION:
ADDRESSES: You may submit comments copies total. One copy will include the
amozie on DSK3GDR082PROD with NOTICES1
information you claim to be confidential I. Background
on any guidance at any time as follows:
with a heading or cover note that states FDA is announcing the availability of
Electronic Submissions ‘‘THIS DOCUMENT CONTAINS a draft document entitled
Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The ‘‘Recommendations for Reducing the
following way: Agency will review this copy, including Risk of Transfusion-Transmitted
• Federal eRulemaking Portal: the claimed confidential information, in Babesiosis; Draft Guidance for
https://www.regulations.gov. Follow the its consideration of comments. The Industry.’’ The draft guidance document
VerDate Sep<11>2014 17:38 Jul 26, 2018 Jkt 244001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\27JYN1.SGM 27JYN1](https://thefederalregister.org/doc/83_FR_35802/page/1.svg)
![35658 Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices
notifies blood establishments that DEPARTMENT OF HEALTH AND Written/Paper Submissions
collect blood and blood components HUMAN SERVICES Submit written/paper submissions as
that we have determined babesiosis to follows:
be an RTTI under 21 CFR 630.3(h)(2) Food and Drug Administration • Mail/Hand delivery/Courier (for
and provides recommendations for [Docket No. FDA–2018–D–2494] written/paper submissions): Dockets
donor screening, donation testing, donor Management Staff (HFA–305), Food and
deferral, and product management to Peripheral Vascular Atherectomy Drug Administration, 5630 Fishers
reduce the risk of TTB. The Devices—Premarket Notification Lane, Rm. 1061, Rockville, MD 20852.
recommendations contained in the draft Submissions; Draft Guidance for • For written/paper comments
guidance document applies to the Industry and Food and Drug submitted to the Dockets Management
collection of blood and blood Administration Staff; Availability Staff, FDA will post your comment, as
components, except Source Plasma. well as any attachments, except for
AGENCY: Food and Drug Administration, information submitted, marked and
This draft guidance is being issued HHS. identified, as confidential, if submitted
consistent with FDA’s good guidance ACTION: Notice of availability. as detailed in ‘‘Instructions.’’
practices regulation (21 CFR 10.115). Instructions: All submissions received
The draft guidance, when finalized, will SUMMARY: The Food and Drug must include the Docket No. FDA–
represent the current thinking of FDA Administration (FDA or Agency) is 2018–D–2494 for ‘‘Peripheral Vascular
on recommendations for reducing the announcing the availability of the draft Atherectomy Devices—Premarket
risk of transfusion-transmitted guidance entitled ‘‘Peripheral Vascular Notification [510(k)] Submissions.’’
babesiosis. It does not establish any Atherectomy Devices—Premarket Received comments will be placed in
rights for any person and is not binding Notification [510(k)] Submissions.’’ This the docket and, except for those
on FDA or the public. You can use an draft guidance provides submitted as ‘‘Confidential
alternative approach if it satisfies the recommendations for premarket Submissions,’’ publicly viewable at
requirements of the applicable statutes submissions for a new or modified https://www.regulations.gov or at the
and regulations. This guidance is not peripheral vascular atherectomy device. Dockets Management Staff between 9
subject to Executive Order 12866. This draft guidance is not final nor is it a.m. and 4 p.m., Monday through
in effect at this time. Friday.
II. Paperwork Reduction Act of 1995 DATES: Submit either electronic or • Confidential Submissions—To
written comments on the draft guidance submit a comment with confidential
This guidance refers to previously
by September 25, 2018 to ensure that information that you do not wish to be
approved collections of information
the Agency considers your comment on made publicly available, submit your
found in FDA regulations. These this draft guidance before it begins work comments only as a written/paper
collections of information are subject to on the final version of the guidance. submission. You should submit two
review by the Office of Management and
ADDRESSES: You may submit comments copies total. One copy will include the
Budget (OMB) under the Paperwork information you claim to be confidential
on any guidance at any time as follows:
Reduction Act of 1995 (44 U.S.C. 3501– with a heading or cover note that states
3520). The collections of information in Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
21 CFR part 601 have been approved Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
under OMB control number 0910–0338, following way: Agency will review this copy, including
and the collections of information in 21 • Federal eRulemaking Portal: the claimed confidential information, in
CFR part 606, 21 CFR 610.40(h), and 21 https://www.regulations.gov. Follow the its consideration of comments. The
CFR 630.40 have been approved under instructions for submitting comments. second copy, which will have the
OMB control number 0910–0116. Comments submitted electronically, claimed confidential information
including attachments, to https:// redacted/blacked out, will be available
III. Electronic Access
www.regulations.gov will be posted to for public viewing and posted on
Persons with access to the internet the docket unchanged. Because your https://www.regulations.gov. Submit
may obtain the draft guidance at either comment will be made public, you are both copies to the Dockets Management
http://www.fda.gov/Biologics solely responsible for ensuring that your Staff. If you do not wish your name and
BloodVaccines/GuidanceCompliance comment does not include any contact information to be made publicly
RegulatoryInformation/Guidances/ confidential information that you or a available, you can provide this
default.htm or https:// third party may not wish to be posted, information on the cover sheet and not
such as medical information, your or in the body of your comments and you
www.regulations.gov.
anyone else’s Social Security number, or must identify this information as
Dated: July 20, 2018. confidential business information, such ‘‘confidential.’’ Any information marked
Leslie Kux, as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed
Associate Commissioner for Policy. that if you include your name, contact except in accordance with 21 CFR 10.20
[FR Doc. 2018–16030 Filed 7–26–18; 8:45 am] information, or other information that and other applicable disclosure law. For
identifies you in the body of your more information about FDA’s posting
BILLING CODE 4164–01–P
comments, that information will be of comments to public dockets, see 80
posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access
amozie on DSK3GDR082PROD with NOTICES1
• If you want to submit a comment the information at: https://www.gpo.gov/
with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015-
do not wish to be made available to the 23389.pdf.
public, submit the comment as a Docket: For access to the docket to
written/paper submission and in the read background documents or the
manner detailed (see ‘‘Written/Paper electronic and written/paper comments
Submissions’’ and ‘‘Instructions’’). received, go to https://
VerDate Sep<11>2014 17:38 Jul 26, 2018 Jkt 244001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\27JYN1.SGM 27JYN1](https://thefederalregister.org/doc/83_FR_35802/page/2.svg)
Document Created: 2018-07-27 04:04:54
Document Modified: 2018-07-27 04:04:54
| 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 September 25, 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 | Valerie A. Butler, 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 35657 |
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