81 FR 50708 - Determining Donor Eligibility for Autologous Donors of Blood and Blood Components Intended Solely for Autologous Use-Compliance Policy; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 148 (August 2, 2016)

Page Range		50708-50710
FR Document		2016-18183

The Food and Drug Administration (FDA or Agency or we) is announcing the availability of a document titled ``Determining Donor Eligibility for Autologous Donors of Blood and Blood Components Intended Solely for Autologous Use--Compliance Policy; Guidance for Industry.'' This guidance addresses the regulatory requirements for determining donor eligibility that apply to establishments that collect blood and blood components (blood establishments) intended solely for autologous use. On May 22, 2015, in order to better assure the safety of the nation's blood supply and to help protect donor health, FDA finalized its revision of the applicable requirements for blood establishments to test donors for infectious disease, and to determine that donors are eligible to donate and that donations are suitable for transfusion or further manufacture (``Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use'' (donor eligibility rule)). The donor eligibility rule includes requirements related to current good manufacturing practice, donation testing, donor eligibility, and donation suitability. It became effective on May 23, 2016. FDA has developed this guidance in response to questions from blood establishments concerning the applicability of the donor eligibility rule to autologous donations. The guidance explains the conditions under which FDA does not intend to take regulatory action for a blood establishment's failure to comply with certain donor eligibility determination requirements in collecting blood and blood components intended solely for autologous use.

Federal Register, Volume 81 Issue 148 (Tuesday, August 2, 2016)

[Federal Register Volume 81, Number 148 (Tuesday, August 2, 2016)]
[Notices]
[Pages 50708-50710]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-18183]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-2071]

Determining Donor Eligibility for Autologous Donors of Blood and
Blood Components Intended Solely for Autologous Use--Compliance Policy;
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency or we) is
announcing the availability of a document titled ``Determining Donor
Eligibility for Autologous Donors of Blood and Blood Components
Intended Solely for Autologous Use--Compliance Policy; Guidance for
Industry.'' This guidance addresses the regulatory requirements for
determining donor

[[Page 50709]]

eligibility that apply to establishments that collect blood and blood
components (blood establishments) intended solely for autologous use.
On May 22, 2015, in order to better assure the safety of the nation's
blood supply and to help protect donor health, FDA finalized its
revision of the applicable requirements for blood establishments to
test donors for infectious disease, and to determine that donors are
eligible to donate and that donations are suitable for transfusion or
further manufacture (``Requirements for Blood and Blood Components
Intended for Transfusion or for Further Manufacturing Use'' (donor
eligibility rule)). The donor eligibility rule includes requirements
related to current good manufacturing practice, donation testing, donor
eligibility, and donation suitability. It became effective on May 23,
2016.
FDA has developed this guidance in response to questions from blood
establishments concerning the applicability of the donor eligibility
rule to autologous donations. The guidance explains the conditions
under which FDA does not intend to take regulatory action for a blood
establishment's failure to comply with certain donor eligibility
determination requirements in collecting blood and blood components
intended solely for autologous use.

DATES: The Agency is soliciting public comment, but is implementing
this guidance immediately because the Agency has determined that prior
public participation is not feasible or appropriate. Submit either
electronic or written comments on Agency guidances at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2016-D-2071 for ``Determining Donor Eligibility for Autologous
Donors of Blood and Blood Components Intended Solely for Autologous
Use--Compliance Policy; Guidance for Industry.'' Received comments will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
Submit written requests for single copies of the 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 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 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 document entitled
``Requirements for Determining Donor Eligibility for Autologous Donors
of Blood and Blood Components Intended Solely for Autologous Use--
Compliance Policy; Guidance for Industry.'' We are implementing this
guidance without prior public comment because we have determined that
prior public participation is not feasible or appropriate (Sec.
10.115(g)(2)). Although this guidance document is immediately in
effect, it remains subject to comment in accordance with FDA's good
guidance practices regulation.
This guidance addresses the regulatory requirements for determining
donor eligibility that apply to blood establishments that collect blood
and blood components intended solely for autologous use described in
the final

[[Page 50710]]

rule entitled, ``Requirements for Blood and Blood Components Intended
for Transfusion or for Further Manufacturing Use,'' 80 FR 29842 (donor
eligibility rule)) that became effective on May 23, 2016.
A small proportion of collections of blood and blood components are
intended for autologous transfusion. In those instances, the autologous
donor presents with a physician's prescription for the collection of
the donor's blood for the donor's own upcoming medical (e.g., surgical)
procedure. If the donor ultimately does not need the blood, blood
establishments may, in some instances, use these donations for
allogeneic (i.e. intended for transfusion to a recipient other than the
donor) transfusions. This is referred to as ``cross-over.''
Blood establishments have requested clarification on certain
requirements of the donor eligibility rule and the applicability of
certain sections of the donor eligibility rule to the collection of
blood and blood components intended for autologous use. To address
these questions, FDA has developed this guidance to clarify the
Agency's policy with respect to the requirements for autologous donors
of blood and blood components intended solely for autologous use,
(i.e., not subject to cross-over). Specifically, the guidance describes
FDA's policy with respect to the following: The requirements in 21 CFR
630.10 related to screening autologous donors for relevant transfusion-
transmitted infections; the requirement in 21 CFR 630.15(a)(1)(ii) that
the responsible physician examine the autologous donor to permit more
frequent collections; and, the requirement in 21 CFR 630.20(a) that the
responsible physician determine and document that the autologous
donor's health permits the collection of blood and blood components
intended for autologous use.
Autologous donors have long been permitted to donate blood for
their own use even if they do not meet certain donor eligibility
criteria that apply to allogeneic donors because autologous donors are
not exposed to new transfusion-transmitted infections in receiving
their own blood. For example, FDA does not require testing of
autologous donations for Relevant Transfusion-Transmitted Infection
(RTTI) unless the donations are used for allogeneic transfusion or
shipped to another establishment (21 CFR 610.40(d)). Consistent with
this approach to testing autologous donations, FDA does not believe it
is necessary to assess autologous donors for risks for RTTI as required
in certain provisions in Sec. 630.10 if the donation is intended
solely for autologous use.
Sections 630.15(a) and 630.20(a) describe conditions for which a
responsible physician must examine and determine and document that the
autologous donor's health permits a collection procedure. Autologous
donors are under the care of the physician who prescribes the
autologous donation. In light of the medical oversight provided by the
autologous donor's physician, FDA believes blood establishments can
appropriately protect autologous donors' health by following standard
operating procedures that are approved by the responsible physician of
the blood establishment and that define criteria for when the
autologous donation may proceed and the conditions under which the
responsible physician must be consulted.
The guidance explains the conditions under which FDA does not
intend to take regulatory action for a blood establishment's failure to
comply with the donor eligibility determination requirements in
collecting blood and blood components intended solely for autologous
use.
The guidance represents the current thinking of the FDA on this
topic. 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.

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 part 630 have been approved under OMB
control number 0910-0795.

III. Electronic Access

Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

Dated: July 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-18183 Filed 8-1-16; 8:45 am]
BILLING CODE 4164-01-P

50708 Federal Register / Vol. 81, No. 148 / Tuesday, August 2, 2016 / Notices

drug products for use in the treatment organizations, (2) be able to analyze which the nominee is recommended. In
of gastrointestinal diseases. technical data, (3) understand research addition, nominations should include
design, (4) discuss benefits and risks, confirmation that the nominee is aware
D. Medical Imaging Advisory Committee
and (5) evaluate the safety and efficacy of the nomination, unless self-
Reviews and evaluates data of products under review. The nominated. FDA will ask potential
concerning the safety and effectiveness consumer representative should be able candidates to provide detailed
of marketed and investigational human to represent the consumer perspective information concerning such matters as
drug products for use in diagnostic and on issues and actions before the financial holdings, employment, and
therapeutic procedures using advisory committee; serve as a liaison research grants and/or contracts to
radioactive pharmaceuticals and between the committee and interested permit evaluation of possible sources of
contrast media used in diagnostic consumers, associations, coalitions, and conflicts of interest. Members will be
radiology. consumer organizations; and facilitate invited to serve for terms up to 4 years.
dialogue with the advisory committees FDA will review all nominations
E. National Mammography Quality
on scientific issues that affect received within the specified
Assurance Advisory Committee timeframes and prepare a ballot
consumers.
Advises the Agency on the following: containing the names of qualified
(1) Development of appropriate quality IV. Selection Procedures nominees. Names not selected will
standards and regulations for Selection of members representing remain on a list of eligible nominees
mammography facilities; (2) standards consumer interests is conducted and be reviewed periodically by FDA to
and regulations for bodies accrediting through procedures that include the use determine continued interest. Upon
mammography facilities under this of organizations representing the public selecting qualified nominees for the
program; regulations with respect to interest and public advocacy groups. ballot, FDA will provide those
sanctions; (3) procedures for monitoring These organizations recommend consumer organizations that are
compliance with standards; (4) nominees for the Agency’s selection. participating in the selection process
establishing a mechanism to investigate Representatives from the consumer with the opportunity to vote on the
consumer complaints; (5) reporting new health branches of Federal, State, and listed nominees. Only organizations
developments concerning breast local governments also may participate vote in the selection process. Persons
imaging which should be considered in in the selection process. Any consumer who nominate themselves to serve as
the oversight of mammography organization interested in participating voting or nonvoting consumer
facilities; (6) determining whether there in the selection of an appropriate voting representatives will not participate in
exists a shortage of mammography or nonvoting member to represent the selection process.
facilities in rural and health consumer interests should send a letter This notice is issued under the
professional shortage areas and stating that interest to FDA (see Federal Advisory Committee Act (5
determining the effects of personnel on ADDRESSES) within 30 days of U.S.C. app. 2) and 21 CFR part 14,
access to the services of such facilities publication of this document. relating to advisory committees.
in such areas; (7) determining whether Within the subsequent 30 days, FDA Dated: July 27, 2016.
there will exist a sufficient number of will compile a list of consumer
Janice M. Soreth,
medical physicists after October 1, 1999; organizations that will participate in the
Acting Associate Commissioner, Special
and (8) determining the costs and selection process and will forward to
Medical Programs.
benefits of compliance with these each such organization a ballot listing at
[FR Doc. 2016–18216 Filed 8–1–16; 8:45 am]
requirements. least two qualified nominees selected by
BILLING CODE 4164–01–P
the Agency based on the nominations
F. Peripheral and Central Nervous received, together with each nominee’s
System Advisory Committee current curriculum vitae or resume.
DEPARTMENT OF HEALTH AND
Reviews and evaluates data Ballots are to be filled out and returned
HUMAN SERVICES
concerning the safety and effectiveness to FDA within 30 days. The nominee
of marketed and investigational human receiving the highest number of votes Food and Drug Administration
drug products for use in the treatment ordinarily will be selected to serve as
of neurologic diseases. the member representing consumer [Docket No. FDA–2016–D–2071]
interests for that particular advisory
G. Vaccines and Related Biological Determining Donor Eligibility for
committee or panel.
Products Advisory Committee Autologous Donors of Blood and
Reviews and evaluates data V. Nomination Procedures Blood Components Intended Solely for
concerning the safety, effectiveness, and Any interested person or organization Autologous Use—Compliance Policy;
appropriate use of vaccines and related may nominate one or more qualified Guidance for Industry; Availability
biological products which are intended persons to represent consumer interests AGENCY: Food and Drug Administration,
for use in the prevention, treatment, or on the Agency’s advisory committees or HHS.
diagnosis of human diseases, as well as panels. Self-nominations are also ACTION: Notice of availability.
considers the quality and relevance of accepted. Nominations should include a
FDA’s research program which provides cover letter and current curriculum SUMMARY: The Food and Drug
scientific support for the regulation of vitae or resume for each nominee, Administration (FDA or Agency or we)
including a current business and/or is announcing the availability of a
mstockstill on DSK3G9T082PROD with NOTICES

these products.
home address, telephone number, and document titled ‘‘Determining Donor
III. Criteria for Members email address if available, and a list of Eligibility for Autologous Donors of
Persons nominated for membership as consumer or community-based Blood and Blood Components Intended
consumer representatives on organizations for which the candidate Solely for Autologous Use—Compliance
committees or panels should meet the can demonstrate active participation. Policy; Guidance for Industry.’’ This
following criteria: (1) Demonstrate ties Nominations should also specify the guidance addresses the regulatory
to consumer and community-based advisory committee(s) or panel(s) for requirements for determining donor

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50710 Federal Register / Vol. 81, No. 148 / Tuesday, August 2, 2016 / Notices

rule entitled, ‘‘Requirements for Blood provisions in § 630.10 if the donation is DEPARTMENT OF HEALTH AND
and Blood Components Intended for intended solely for autologous use. HUMAN SERVICES
Transfusion or for Further Sections 630.15(a) and 630.20(a)
Manufacturing Use,’’ 80 FR 29842 Food and Drug Administration
describe conditions for which a
(donor eligibility rule)) that became
responsible physician must examine [Docket No. FDA–2016–P–0974]
effective on May 23, 2016.
A small proportion of collections of and determine and document that the
autologous donor’s health permits a Determination That SAMSCA
blood and blood components are (Tolvaptan) Tablets, 60 Milligrams,
intended for autologous transfusion. In collection procedure. Autologous
donors are under the care of the Were Not Withdrawn From Sale for
those instances, the autologous donor Reasons of Safety or Effectiveness
presents with a physician’s prescription physician who prescribes the
for the collection of the donor’s blood autologous donation. In light of the AGENCY: Food and Drug Administration,
for the donor’s own upcoming medical medical oversight provided by the HHS.
(e.g., surgical) procedure. If the donor autologous donor’s physician, FDA ACTION: Notice.
ultimately does not need the blood, believes blood establishments can
blood establishments may, in some appropriately protect autologous SUMMARY: The Food and Drug
instances, use these donations for donors’ health by following standard Administration (FDA or Agency) has
allogeneic (i.e. intended for transfusion operating procedures that are approved determined that SAMSCA (tolvaptan)
to a recipient other than the donor) by the responsible physician of the tablets, 60 milligrams (mg), were not
transfusions. This is referred to as blood establishment and that define withdrawn from sale for reasons of
‘‘cross-over.’’ criteria for when the autologous safety or effectiveness. This
Blood establishments have requested donation may proceed and the determination will allow FDA to
clarification on certain requirements of conditions under which the responsible approve abbreviated new drug
the donor eligibility rule and the applications (ANDAs) for tolvaptan
physician must be consulted.
applicability of certain sections of the tablets, 60 mg, if all other legal and
donor eligibility rule to the collection of The guidance explains the conditions regulatory requirements are met.
blood and blood components intended under which FDA does not intend to
FOR FURTHER INFORMATION CONTACT:
for autologous use. To address these take regulatory action for a blood
Christopher Koepke, Center for Drug
questions, FDA has developed this establishment’s failure to comply with
Evaluation and Research, Food and
guidance to clarify the Agency’s policy the donor eligibility determination
Drug Administration, 10903 New
with respect to the requirements for requirements in collecting blood and Hampshire Ave., Bldg. 51, Rm. 6214,
autologous donors of blood and blood blood components intended solely for Silver Spring, MD 20993–0002, 240–
components intended solely for autologous use. 402–3543.
autologous use, (i.e., not subject to The guidance represents the current
cross-over). Specifically, the guidance SUPPLEMENTARY INFORMATION: In 1984,
thinking of the FDA on this topic. It Congress enacted the Drug Price
describes FDA’s policy with respect to
does not establish any rights for any Competition and Patent Term
the following: The requirements in 21
person and is not binding on FDA or the Restoration Act of 1984 (Pub. L. 98–417)
CFR 630.10 related to screening
autologous donors for relevant public. You can use an alternative (the 1984 amendments), which
transfusion-transmitted infections; the approach if it satisfies the requirements authorized the approval of duplicate
requirement in 21 CFR 630.15(a)(1)(ii) of the applicable statutes and versions of drug products under an
that the responsible physician examine regulations. ANDA procedure. ANDA applicants
the autologous donor to permit more must, with certain exceptions, show that
II. Paperwork Reduction Act of 1995
frequent collections; and, the the drug for which they are seeking
requirement in 21 CFR 630.20(a) that This guidance refers to previously approval contains the same active
the responsible physician determine approved collections of information ingredient in the same strength and
and document that the autologous found in FDA regulations. These dosage form as the ‘‘listed drug,’’ which
donor’s health permits the collection of collections of information are subject to is a version of the drug that was
blood and blood components intended review by the Office of Management and previously approved. ANDA applicants
for autologous use. Budget (OMB) under the Paperwork do not have to repeat the extensive
Autologous donors have long been Reduction Act of 1995 (44 U.S.C. 3501– clinical testing otherwise necessary to
permitted to donate blood for their own gain approval of a new drug application
3520). The collections of information in
use even if they do not meet certain (NDA).
part 630 have been approved under
donor eligibility criteria that apply to The 1984 amendments include what
OMB control number 0910–0795.
allogeneic donors because autologous is now section 505(j)(7) of the Federal
donors are not exposed to new III. Electronic Access Food, Drug, and Cosmetic Act (21 U.S.C.
transfusion-transmitted infections in 355(j)(7)), which requires FDA to
receiving their own blood. For example, Persons with access to the Internet publish a list of all approved drugs.
FDA does not require testing of may obtain the guidance at either http:// FDA publishes this list as part of the
autologous donations for Relevant www.fda.gov/BiologicsBloodVaccines/ ‘‘Approved Drug Products With
Transfusion-Transmitted Infection GuidanceComplianceRegulatory Therapeutic Equivalence Evaluations,’’
(RTTI) unless the donations are used for Information/Guidances/default.htm or which is known generally as the
mstockstill on DSK3G9T082PROD with NOTICES

allogeneic transfusion or shipped to http://www.regulations.gov. ‘‘Orange Book.’’ Under FDA regulations,
another establishment (21 CFR Dated: July 27, 2016. drugs are removed from the list if the
610.40(d)). Consistent with this Agency withdraws or suspends
Leslie Kux,
approach to testing autologous approval of the drug’s NDA or ANDA
donations, FDA does not believe it is Associate Commissioner for Policy. for reasons of safety or effectiveness or
necessary to assess autologous donors [FR Doc. 2016–18183 Filed 8–1–16; 8:45 am] if FDA determines that the listed drug
for risks for RTTI as required in certain BILLING CODE 4164–01–P was withdrawn from sale for reasons of

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Document Created: 2016-08-02 01:47:35
Document Modified: 2016-08-02 01:47:35

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		The Agency is soliciting public comment, but is implementing this guidance immediately because the Agency has determined that prior public participation is not feasible or appropriate. Submit either electronic or written comments on Agency guidances at any time.
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		81 FR 50708

81 FR 50708 - Determining Donor Eligibility for Autologous Donors of Blood and Blood Components Intended Solely for Autologous Use-Compliance Policy; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 148 (August 2, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration