82 FR 61304 - Implementation of Pathogen Reduction Technology in the Manufacture of Blood Components in Blood Establishments: Questions and Answers; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 247 (December 27, 2017)

Page Range		61304-61306
FR Document		2017-28043

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Implementation of Pathogen Reduction Technology in the Manufacture of Blood Components in Blood Establishments: Questions and Answers; Draft Guidance for Industry.'' The draft guidance document provides blood establishments that collect or process blood and blood components with recommendations for implementing pathogen reduction technology in the manufacture of pathogen-reduced blood components. The guidance also provides answers to frequently asked questions concerning the implementation of the INTERCEPT[supreg] Blood System for Platelets and Plasma. The recommendations apply to licensed blood establishments that intend to manufacture pathogen-reduced blood components using an FDA approved pathogen reduction device.

Federal Register, Volume 82 Issue 247 (Wednesday, December 27, 2017)

[Federal Register Volume 82, Number 247 (Wednesday, December 27, 2017)]
[Notices]
[Pages 61304-61306]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2017-28043]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6784]

Implementation of Pathogen Reduction Technology in the
Manufacture of Blood Components in Blood Establishments: Questions and
Answers; Draft Guidance for Industry; Availability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 ``Implementation of
Pathogen Reduction Technology in the Manufacture of Blood Components in
Blood Establishments: Questions and Answers; Draft Guidance for
Industry.'' The draft guidance document provides blood establishments
that collect or process blood and blood components with recommendations
for implementing pathogen reduction technology in the manufacture of
pathogen-reduced blood components. The guidance also provides answers
to frequently asked questions concerning the implementation of the
INTERCEPT[supreg] Blood System for Platelets and Plasma. The
recommendations apply to licensed blood establishments that intend to
manufacture pathogen-reduced blood components using an FDA approved
pathogen reduction device.

DATES: Submit either electronic or written comments on the draft
guidance by March 27, 2018 to ensure that the Agency considers your
comment on this

[[Page 61305]]

draft guidance before it begins work on the final version of the
guidance.

ADDRESSES: You may submit comments 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-2017-D-6784 for ``Implementation of Pathogen Reduction Technology
in the Manufacture of Blood Components in Blood Establishments:
Questions and Answer; 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, 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
``Implementation of Pathogen Reduction Technology in the Manufacture of
Blood Components in Blood Establishments: Questions and Answers; Draft
Guidance for Industry.'' The draft guidance provides blood
establishments that collect or process blood and blood components with
recommendations for implementing pathogen reduction technology in the
manufacture of pathogen-reduced blood components. The draft guidance
also provides recommendations to licensed manufacturers on reporting
the manufacturing changes associated with implementation of pathogen
reduction technology under 21 CFR 601.12. Currently, the
INTERCEPT[supreg] Blood System for Platelets and Plasma has been
approved for the manufacture of certain pathogen-reduced platelet and
plasma products. The draft guidance provides answers to frequently
asked questions from blood establishments concerning the implementation
of the INTERCEPT[supreg] Blood System for Platelets and Plasma. If the
product platform for this device changes or FDA approves another device
with a similar intended use in the future, the Agency will consider
providing additional recommendations to blood establishments.
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 implementation
of pathogen reduction technology in the manufacture of blood components
in blood establishments. 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. 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

[[Page 61306]]

630.10 have been approved under OMB control number 0910-0795.

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: December 22, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-28043 Filed 12-26-17; 8:45 am]
BILLING CODE 4164-01-P

61304 Federal Register / Vol. 82, No. 247 / Wednesday, December 27, 2017 / Notices

requested must be filed in paper form, relinquish its status as a PSO for any a PSO’s listing expires. Section 3.108(d)
must be clearly labeled ‘‘Confidential,’’ reason, or when a PSO’s listing expires. of the Patient Safety Rule requires
and must comply with FTC Rule 4.9(c). AHRQ has accepted a notification of AHRQ to provide public notice when it
In particular, the written request for voluntary relinquishment from the removes an organization from the list of
confidential treatment that accompanies Regenstrief Center for Healthcare federally approved PSOs.
the comment must include the factual Engineering at Purdue University AHRQ has accepted a notification
and legal basis for the request, and must Patient Safety Organization (RCHE from RCHE Purdue PSO, a component
identify the specific portions of the Purdue PSO) of its status as a PSO, and entity of Purdue University, PSO
comment to be withheld from the public has delisted the PSO accordingly. number P0168, to voluntarily relinquish
record. See FTC Rule 4.9(c). Your DATES: The directories for both listed its status as a PSO. Accordingly, RCHE
comment will be kept confidential only and delisted PSOs are ongoing and Purdue PSO was delisted effective at
if the General Counsel grants your reviewed weekly by AHRQ. The 12:00 Midnight ET (2400) on December
request in accordance with the law and delisting was effective at 12:00 Midnight 15, 2017.
the public interest. Once your comment ET (2400) on December 15, 2017. More information on PSOs can be
has been posted on the public FTC ADDRESSES: Both directories can be obtained through AHRQ’s PSO website
website—as legally required by FTC accessed electronically at the following at http://www.pso.ahrq.gov.
Rule 4.9(b)—we cannot redact or HHS website: http://www.pso.ahrq.gov/
remove your comment from the FTC Sharon B. Arnold,
listed. Deputy Director.
website, unless you submit a
FOR FURTHER INFORMATION CONTACT:
confidentiality request that meets the [FR Doc. 2017–27803 Filed 12–26–17; 8:45 am]
requirements for such treatment under Eileen Hogan, Center for Quality BILLING CODE 4160–90–P
FTC Rule 4.9(c), and the General Improvement and Patient Safety, AHRQ,
Counsel grants that request. 5600 Fishers Lane, Room 06N94B,
The FTC Act and other laws that the Rockville, MD 20857; Telephone (toll DEPARTMENT OF HEALTH AND
Commission administers permit the free): (866) 403–3697; Telephone (local): HUMAN SERVICES
collection of public comments to (301) 427–1111; TTY (toll free): (866)
consider and use in this proceeding as 438–7231; TTY (local): (301) 427–1130; Food and Drug Administration
appropriate. The Commission will Email: pso@ahrq.hhs.gov.
consider all timely and responsive SUPPLEMENTARY INFORMATION: [Docket No. FDA–2017–D–6784]
public comments that it receives on or Background
before January 26, 2018. For information Implementation of Pathogen Reduction
on the Commission’s privacy policy, The Patient Safety and Quality Technology in the Manufacture of
including routine uses permitted by the Improvement Act of 2005, 42 U.S.C. Blood Components in Blood
Privacy Act, see https://www.ftc.gov/ 299b–21 to b–26, (Patient Safety Act) Establishments: Questions and
site-information/privacy-policy. and the related Patient Safety and Answers; Draft Guidance for Industry;
Quality Improvement Final Rule, 42 Availability
David C. Shonka, CFR part 3 (Patient Safety Rule),
Acting General Counsel. published in the Federal Register on AGENCY: Food and Drug Administration,
[FR Doc. 2017–27868 Filed 12–26–17; 8:45 am] November 21, 2008, 73 FR 70732– HHS.
BILLING CODE 6750–01–P 70814, establish a framework by which ACTION: Notice of availability.
hospitals, doctors, and other health care
providers may voluntarily report SUMMARY: The Food and Drug
DEPARTMENT OF HEALTH AND information to Patient Safety Administration (FDA or Agency) is
HUMAN SERVICES Organizations (PSOs), on a privileged announcing the availability of a draft
and confidential basis, for the document entitled ‘‘Implementation of
Agency for Healthcare Research and aggregation and analysis of patient Pathogen Reduction Technology in the
Quality safety events. Manufacture of Blood Components in
The Patient Safety Act authorizes the Blood Establishments: Questions and
Patient Safety Organizations: listing of PSOs, which are entities or Answers; Draft Guidance for Industry.’’
Voluntary Relinquishment From the component organizations whose The draft guidance document provides
Regenstrief Center for Healthcare mission and primary activity are to blood establishments that collect or
Engineering at Purdue University conduct activities to improve patient process blood and blood components
Patient Safety Organization (RCHE safety and the quality of health care with recommendations for
Purdue PSO) delivery. implementing pathogen reduction
HHS issued the Patient Safety Rule to technology in the manufacture of
AGENCY: Agency for Healthcare Research
implement the Patient Safety Act. pathogen-reduced blood components.
and Quality (AHRQ), Department of
AHRQ administers the provisions of the The guidance also provides answers to
Health and Human Services (HHS).
Patient Safety Act and Patient Safety frequently asked questions concerning
ACTION: Notice of delisting.
Rule relating to the listing and operation the implementation of the INTERCEPT®
SUMMARY: The Patient Safety Rule of PSOs. The Patient Safety Rule Blood System for Platelets and Plasma.
authorizes AHRQ, on behalf of the authorizes AHRQ to list as a PSO an The recommendations apply to licensed
Secretary of HHS, to list as a PSO an entity that attests that it meets the blood establishments that intend to
daltland on DSKBBV9HB2PROD with NOTICES

entity that attests that it meets the statutory and regulatory requirements manufacture pathogen-reduced blood
statutory and regulatory requirements for listing. A PSO can be ‘‘delisted’’ if components using an FDA approved
for listing. A PSO can be ‘‘delisted’’ by it is found to no longer meet the pathogen reduction device.
the Secretary if it is found to no longer requirements of the Patient Safety Act DATES: Submit either electronic or
meet the requirements of the Patient and Patient Safety Rule, when a PSO written comments on the draft guidance
Safety Act and Patient Safety Rule, chooses to voluntarily relinquish its by March 27, 2018 to ensure that the
when a PSO chooses to voluntarily status as a PSO for any reason, or when Agency considers your comment on this

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61306 Federal Register / Vol. 82, No. 247 / Wednesday, December 27, 2017 / Notices

630.10 have been approved under OMB Secretary of HHS, who is named as the Vaccine Injury Table the first symptom
control number 0910–0795. respondent in each proceeding. The or manifestation of the onset or
Secretary has delegated this significant aggravation of which did not
III. Electronic Access
responsibility under the Program to occur within the time period set forth in
Persons with access to the internet HRSA. The Court is directed by statute the Table but which was caused by a
may obtain the draft guidance at either to appoint special masters who take vaccine’’ referred to in the Table.
https://www.fda.gov/BiologicsBlood evidence, conduct hearings as In accordance with Section
Vaccines/GuidanceCompliance appropriate, and make initial decisions 2112(b)(2), all interested persons may
RegulatoryInformation/Guidances/ as to eligibility for, and amount of, submit written information relevant to
default.htm or https:// compensation. the issues described above in the case of
www.regulations.gov. A petition may be filed with respect the petitions listed below. Any person
Dated: December 22, 2017. to injuries, disabilities, illnesses, choosing to do so should file an original
Leslie Kux, conditions, and deaths resulting from and three (3) copies of the information
Associate Commissioner for Policy. vaccines described in the Vaccine Injury with the Clerk of the U.S. Court of
Table (the table) set forth at 42 CFR Federal Claims at the address listed
[FR Doc. 2017–28043 Filed 12–26–17; 8:45 am]
100.3. This table lists for each covered above (under the heading ‘‘FOR FURTHER
BILLING CODE 4164–01–P
childhood vaccine the conditions that INFORMATION CONTACT’’), with a copy to
may lead to compensation and, for each HRSA addressed to Director, Division of
DEPARTMENT OF HEALTH AND condition, the time period for Injury Compensation Programs,
HUMAN SERVICES occurrence of the first symptom or Healthcare Systems Bureau, 5600
manifestation of onset or of significant Fishers Lane, 08N146B, Rockville, MD
Health Resources and Services aggravation after vaccine 20857. The Court’s caption (Petitioner’s
Administration administration. Compensation may also Name v. Secretary of HHS) and the
be awarded for conditions not listed in docket number assigned to the petition
National Vaccine Injury Compensation the Table and for conditions that are should be used as the caption for the
Program; List of Petitions Received manifested outside the time periods written submission. Chapter 35 of title
specified in the table, but only if the 44, United States Code, related to
AGENCY: Health Resources and Services
petitioner shows that the condition was paperwork reduction, does not apply to
Administration (HRSA), Department of
caused by one of the listed vaccines. information required for purposes of
Health and Human Services (HHS). Section 2112(b)(2) of the PHS Act, 42 carrying out the Program.
ACTION: Notice. U.S.C. 300aa–12(b)(2), requires that Dated: December 18, 2017.
SUMMARY: HRSA is publishing this ‘‘[w]ithin 30 days after the Secretary
George Sigounas,
notice of petitions received under the receives service of any petition filed
under section 2111 the Secretary shall Administrator.
National Vaccine Injury Compensation
Program (the program), as required by publish notice of such petition in the List of Petitions Filed
the Public Health Service (PHS) Act, as Federal Register.’’ Set forth below is a 1. Alina Derkach on behalf of E.E.D.,
amended. While the Secretary of HHS is list of petitions received by HRSA on Richmond, Virginia, Court of
named as the respondent in all November 1, 2017, through November Federal Claims No: 17–1648V
proceedings brought by the filing of 30, 2017. This list provides the name of 2. Patsy Gipson on behalf of Alfred J.
petitions for compensation under the petitioner, city and state of vaccination Gipson, Deceased, Garland, Texas,
Program, the United States Court of (if unknown then city and state of Court of Federal Claims No: 17–
Federal Claims is charged by statute person or attorney filing claim), and 1651V
with responsibility for considering and case number. In cases where the Court 3. Katie Reaves, Florence, California,
acting upon the petitions. has redacted the name of a petitioner Court of Federal Claims No: 17–
and/or the case number, the list reflects 1655V
FOR FURTHER INFORMATION CONTACT: For
such redaction. 4. Maria Vasquez, Washington, District
information about requirements for Section 2112(b)(2) also provides that
filing petitions, and the program in of Columbia, Court of Federal
the special master ‘‘shall afford all Claims No: 17–1658V
general, contact Lisa L. Reyes, Acting interested persons an opportunity to
Clerk, United States Court of Federal 5. Berill Blair, Fairbanks, Alaska, Court
submit relevant, written information’’ of Federal Claims No: 17–1659V
Claims, 717 Madison Place NW, relating to the following: 6. Kari Lafferty, Roseville, California,
Washington, DC 20005, (202) 357–6400. 1. The existence of evidence ‘‘that Court of Federal Claims No: 17–
For information on HRSA’s role in the there is not a preponderance of the 1660V
Program, contact the Director, National evidence that the illness, disability, 7. Wendi Walter and Phillip Walter on
Vaccine Injury Compensation Program, injury, condition, or death described in behalf of M.W., Decatur, Georgia,
5600 Fishers Lane, Room 08N146B, the petition is due to factors unrelated Court of Federal Claims No: 17–
Rockville, MD 20857; (301) 443–6593, to the administration of the vaccine 1663V
or visit our website at: http://www.hrsa. described in the petition,’’ and 8. Robert Neal, Eagan, Minnesota, Court
gov/vaccinecompensation/index.html. 2. Any allegation in a petition that the of Federal Claims No: 17–1690V
SUPPLEMENTARY INFORMATION: The petitioner either: 9. Angela Kay Stacy, Hazard, Kentucky,
program provides a system of no-fault a. ‘‘[S]ustained, or had significantly Court of Federal Claims No: 17–
compensation for certain individuals aggravated, any illness, disability, 1691V
daltland on DSKBBV9HB2PROD with NOTICES

who have been injured by specified injury, or condition not set forth in the 10. Elizabeth Argiri and Samuel Argiri
childhood vaccines. Subtitle 2 of Title Vaccine Injury Table but which was on behalf of L.A., Roseville,
XXI of the PHS Act, 42 U.S.C. 300aa– caused by’’ one of the vaccines referred Michigan, Court of Federal Claims
10 et seq., provides that those seeking to in the Table, or No: 17–1715V
compensation are to file a petition with b. ‘‘[S]ustained, or had significantly 11. Mary Jo Accetta, Seattle,
the U.S. Court of Federal Claims and to aggravated, any illness, disability, Washington, Court of Federal
serve a copy of the petition on the injury, or condition set forth in the Claims No: 17–1731V

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Document Created: 2017-12-27 02:23:22
Document Modified: 2017-12-27 02:23:22

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 March 27, 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		Jonathan McKnight, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
FR Citation		82 FR 61304

82 FR 61304 - Implementation of Pathogen Reduction Technology in the Manufacture of Blood Components in Blood Establishments: Questions and Answers; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 247 (December 27, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration