83 FR 62872 - Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services To Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 234 (December 6, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 234 (December 6, 2018)
| Page Range | 62872-62873 | |
| FR Document | 2018-26477 |
[Federal Register Volume 83, Number 234 (Thursday, December 6, 2018)] [Notices] [Pages 62872-62873] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-26477] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-D-1814] Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services To Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry.'' The draft guidance document provides blood collection establishments and transfusion services with recommendations to control the risk of bacterial contamination of room temperature stored platelets intended for transfusion. The guidance provides recommendations for all platelet products, including platelets manufactured by automated methods (apheresis platelets), whole blood derived (WBD) platelets, pooled platelets (pre-storage and post- storage) and platelets stored in additive solutions. The draft guidance replaces the draft guidance of the same title dated March 2016. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 4, 2019. Submit either electronic or written comments on the draft guidance by February 4, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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-2014-D-1814 for ``Bacterial Risk Control Strategies for Blood Collection [[Page 62873]] Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at 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: Jonathan McKnight, Center for Biologics Evaluation and Research, Food and Drug Administration, 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 ``Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry.'' The draft guidance provides blood collection establishments and transfusion services with recommendations to control the risk of bacterial contamination of room temperature stored platelets intended for transfusion. The draft guidance provides recommendations for all platelet products, including platelets manufactured by automated methods (apheresis platelets), WBD platelets, pooled platelets (pre- storage and post-storage) and platelets stored in additive solutions. Additionally, this guidance provides licensed blood establishments with recommendations on how to report implementation of manufacturing and labeling changes under 21 CFR 601.12. The draft guidance replaces the draft guidance of the same title dated March 2016 (81 FR 13798; March 15, 2016). Most recently, FDA convened a Blood Products Advisory Committee (BPAC) meeting in July 2018 to discuss bacterial contamination of platelets and strategies to control the risk. At this meeting, BPAC considered the scientific evidence and operational considerations of all available strategies to control the risk of bacterial contamination of platelets with 5-day and 7-day dating, including bacterial testing strategies using culture-based devices, rapid bacterial detection devices, and the implementation of pathogen reduction technology. The data presented and BPAC's discussion at the July 2018 meeting provided the foundation for the recommendations in this guidance. 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 bacterial risk control strategies for blood collection establishments and transfusion services to enhance the safety and availability of platelets for transfusion. 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; the collections of information in 21 CFR part 606 have been approved under OMB control number 0910-0116; and the collections of information in 21 CFR part 607 have been approved under OMB control number 0910-0052. 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: November 29, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-26477 Filed 12-4-18; 8:45 am] BILLING CODE 4164-01-P
![62872 Federal Register / Vol. 83, No. 234 / Thursday, December 6, 2018 / Notices
ANNUAL BURDEN ESTIMATES
Total Annual Number of Average Annual
Instrument number of number of responses per burden hours burden hours
respondents respondents respondent per response
Previously Approved Burden that Remains
Introductory script, grantee staff .......................................... 8 8 25 0.08 16
Introductory script, program applicants ............................... 600 200 1 0.08 16
Add-on to nFORM to conduct random assignment ............. 8 8 25 0.08 16
Follow-up survey for youth .................................................. 690 230 1 0.5 115
Baseline survey for adults ................................................... 600 200 1 0.5 100
Follow-up survey for adults .................................................. 2,300 767 1 0.75 575
Current Request for Approval
Second follow-up survey for youth ...................................... 1,500 500 1 0.5 250
Second follow-up survey for adults ..................................... 800 267 1 0.75 200
Estimated Total Annual Burden Hours: ........................................................................................................................................ 1,288
Comments: The Department SUMMARY: The Food and Drug • Federal eRulemaking Portal:
specifically requests comments on (a) Administration (FDA or Agency) is https://www.regulations.gov. Follow the
whether the proposed collection of announcing the availability of a draft instructions for submitting comments.
information is necessary for the proper document entitled ‘‘Bacterial Risk Comments submitted electronically,
performance of the functions of the Control Strategies for Blood Collection including attachments, to https://
agency, including whether the Establishments and Transfusion www.regulations.gov will be posted to
information shall have practical utility; Services to Enhance the Safety and the docket unchanged. Because your
(b) the accuracy of the agency’s estimate Availability of Platelets for Transfusion; comment will be made public, you are
of the burden of the proposed collection Draft Guidance for Industry.’’ The draft solely responsible for ensuring that your
of information; (c) the quality, utility, guidance document provides blood comment does not include any
and clarity of the information to be collection establishments and confidential information that you or a
collected; and (d) ways to minimize the transfusion services with third party may not wish to be posted,
burden of the collection of information recommendations to control the risk of such as medical information, your or
on respondents, including through the bacterial contamination of room anyone else’s Social Security number, or
use of automated collection techniques temperature stored platelets intended confidential business information, such
or other forms of information for transfusion. The guidance provides as a manufacturing process. Please note
technology. Consideration will be given recommendations for all platelet that if you include your name, contact
to comments and suggestions submitted products, including platelets information, or other information that
within 60 days of this publication. manufactured by automated methods identifies you in the body of your
(apheresis platelets), whole blood comments, that information will be
Authority: 42 U.S.C. 603; Sec. 811 (b)
Healthy Marriage Promotion and Promoting derived (WBD) platelets, pooled posted on https://www.regulations.gov.
Responsible Fatherhood Grants of the Claims platelets (pre-storage and post-storage) • If you want to submit a comment
Resolution Act of 2010, Pub. L. No. 111–291, and platelets stored in additive with confidential information that you
124 Stat. 3064 solutions. The draft guidance replaces do not wish to be made available to the
the draft guidance of the same title public, submit the comment as a
Mary B. Jones, written/paper submission and in the
dated March 2016.
ACF/OPRE Certifying Officer. manner detailed (see ‘‘Written/Paper
[FR Doc. 2018–26450 Filed 12–4–18; 8:45 am] DATES: Although you can comment on Submissions’’ and ‘‘Instructions’’).
BILLING CODE 4184–73–P any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency Written/Paper Submissions
considers your comment on this draft Submit written/paper submissions as
DEPARTMENT OF HEALTH AND guidance before it begins work on the follows:
HUMAN SERVICES final version of the guidance, submit • Mail/Hand delivery/Courier (for
either electronic or written comments written/paper submissions): Dockets
Food and Drug Administration on the draft guidance by February 4, Management Staff (HFA–305), Food and
2019. Submit either electronic or Drug Administration, 5630 Fishers
[Docket No. FDA–2014–D–1814] Lane, Rm. 1061, Rockville, MD 20852.
written comments on the draft guidance
by February 4, 2019 to ensure that the • For written/paper comments
Bacterial Risk Control Strategies for submitted to the Dockets Management
Blood Collection Establishments and Agency considers your comment on this
draft guidance before it begins work on Staff, FDA will post your comment, as
Transfusion Services To Enhance the
khammond on DSK30JT082PROD with NOTICES
the final version of the guidance. well as any attachments, except for
Safety and Availability of Platelets for information submitted, marked and
Transfusion; Draft Guidance for ADDRESSES: You may submit comments identified, as confidential, if submitted
Industry; Availability on any guidance at any time as follows: as detailed in ‘‘Instructions.’’
AGENCY: Food and Drug Administration, Electronic Submissions Instructions: All submissions received
HHS. must include the Docket No. FDA–
Submit electronic comments in the 2014–D–1814 for ‘‘Bacterial Risk
ACTION: Notice of availability.
following way: Control Strategies for Blood Collection
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![Federal Register / Vol. 83, No. 234 / Thursday, December 6, 2018 / Notices 62873
Establishments and Transfusion one self-addressed adhesive label to practices regulation (21 CFR 10.115).
Services to Enhance the Safety and assist the office in processing your The draft guidance, when finalized, will
Availability of Platelets for Transfusion; requests. The draft guidance may also be represent the current thinking of FDA
Draft Guidance for Industry.’’ Received obtained by mail by calling CBER at 1– on bacterial risk control strategies for
comments will be placed in the docket 800–835–4709 or 240–402–8010. See blood collection establishments and
and, except for those submitted as the SUPPLEMENTARY INFORMATION section transfusion services to enhance the
‘‘Confidential Submissions,’’ publicly for electronic access to the draft safety and availability of platelets for
viewable at https://www.regulations.gov guidance document. transfusion. It does not establish any
or at the Dockets Management Staff FOR FURTHER INFORMATION CONTACT: rights for any person and is not binding
between 9 a.m. and 4 p.m., Monday Jonathan McKnight, Center for Biologics on FDA or the public. You can use an
through Friday. Evaluation and Research, Food and alternative approach if it satisfies the
• Confidential Submissions—To Drug Administration, Center for requirements of the applicable statutes
submit a comment with confidential Biologics Evaluation and Research, and regulations. This guidance is not
information that you do not wish to be Food and Drug Administration, 10903 subject to Executive Order 12866.
made publicly available, submit your New Hampshire Ave., Bldg. 71, Rm.
comments only as a written/paper II. Paperwork Reduction Act of 1995
7301, Silver Spring, MD 20993–0002,
submission. You should submit two 240–402–7911. This draft guidance refers to
copies total. One copy will include the previously approved collections of
SUPPLEMENTARY INFORMATION:
information you claim to be confidential information found in FDA regulations.
with a heading or cover note that states I. Background These collections of information are
‘‘THIS DOCUMENT CONTAINS subject to review by the Office of
FDA is announcing the availability of
CONFIDENTIAL INFORMATION.’’ The Management and Budget (OMB) under
a draft document entitled ‘‘Bacterial
Agency will review this copy, including the Paperwork Reduction Act of 1995
Risk Control Strategies for Blood
the claimed confidential information, in (44 U.S.C. 3501–3520). The collections
Collection Establishments and
its consideration of comments. The of information in 21 CFR part 601 have
second copy, which will have the Transfusion Services to Enhance the
Safety and Availability of Platelets for been approved under OMB control
claimed confidential information number 0910–0338; the collections of
redacted/blacked out, will be available Transfusion; Draft Guidance for
Industry.’’ The draft guidance provides information in 21 CFR part 606 have
for public viewing and posted on been approved under OMB control
https://www.regulations.gov. Submit blood collection establishments and
transfusion services with number 0910–0116; and the collections
both copies to the Dockets Management of information in 21 CFR part 607 have
Staff. If you do not wish your name and recommendations to control the risk of
bacterial contamination of room been approved under OMB control
contact information to be made publicly number 0910–0052.
available, you can provide this temperature stored platelets intended
information on the cover sheet and not for transfusion. The draft guidance III. Electronic Access
in the body of your comments and you provides recommendations for all Persons with access to the internet
must identify this information as platelet products, including platelets may obtain the draft guidance at either
‘‘confidential.’’ Any information marked manufactured by automated methods https://www.fda.gov/Biologics
as ‘‘confidential’’ will not be disclosed (apheresis platelets), WBD platelets, BloodVaccines/GuidanceCompliance
except in accordance with 21 CFR 10.20 pooled platelets (pre-storage and post- RegulatoryInformation/Guidances/
and other applicable disclosure law. For storage) and platelets stored in additive default.htm or https://
more information about FDA’s posting solutions. Additionally, this guidance www.regulations.gov.
of comments to public dockets, see 80 provides licensed blood establishments
with recommendations on how to report Dated: November 29, 2018.
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/ implementation of manufacturing and Leslie Kux,
fdsys/pkg/FR-2015-09-18/pdf/2015- labeling changes under 21 CFR 601.12. Associate Commissioner for Policy.
23389.pdf. The draft guidance replaces the draft [FR Doc. 2018–26477 Filed 12–4–18; 8:45 am]
Docket: For access to the docket to guidance of the same title dated March BILLING CODE 4164–01–P
read background documents or the 2016 (81 FR 13798; March 15, 2016).
electronic and written/paper comments Most recently, FDA convened a Blood
received, go to https:// Products Advisory Committee (BPAC) DEPARTMENT OF HEALTH AND
www.regulations.gov and insert the meeting in July 2018 to discuss bacterial HUMAN SERVICES
docket number, found in brackets in the contamination of platelets and strategies
heading of this document, into the to control the risk. At this meeting, Health Resources and Services
‘‘Search’’ box and follow the prompts BPAC considered the scientific evidence Administration
and/or go to the Dockets Management and operational considerations of all
available strategies to control the risk of Solicitation of Nominations for
Staff, 5630 Fishers Lane, Rm. 1061,
bacterial contamination of platelets with Membership To Serve on the Advisory
Rockville, MD 20852.
5-day and 7-day dating, including Committee on Heritable Disorders in
You may submit comments on any
bacterial testing strategies using culture- Newborns and Children
guidance at any time (see 21 CFR
10.115(g)(5)). based devices, rapid bacterial detection AGENCY: Health Resources and Services
Submit written requests for single devices, and the implementation of
khammond on DSK30JT082PROD with NOTICES
Administration (HRSA), Department of
copies of the draft guidance to the Office pathogen reduction technology. The Health and Human Services (HHS).
of Communication, Outreach and data presented and BPAC’s discussion ACTION: Request for nominations.
Development, Center for Biologics at the July 2018 meeting provided the
Evaluation and Research (CBER), Food foundation for the recommendations in SUMMARY: HRSA is seeking nominations
and Drug Administration, 10903 New this guidance. of qualified candidates to be considered
Hampshire Ave., Bldg. 71, Rm. 3128, This draft guidance is being issued for appointment as members of the
Silver Spring, MD 20993–0002. Send consistent with FDA’s good guidance Advisory Committee on Heritable
VerDate Sep<11>2014 20:35 Dec 04, 2018 Jkt 247001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\06DEN1.SGM 06DEN1](https://thefederalregister.org/doc/83_FR_63106/page/2.svg)
Document Created: 2018-12-05 02:35:43
Document Modified: 2018-12-05 02:35:43
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 4, 2019. Submit either electronic or written comments on the draft guidance by February 4, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Jonathan McKnight, Center for Biologics Evaluation and Research, Food and Drug Administration, 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 62872 |
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