Determination That SAMSCA (Tolvaptan) Tablets, 60 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 50710-50711 [2016-18139]
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Federal Register / Vol. 81, No. 148 / Tuesday, August 2, 2016 / Notices
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
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18:35 Aug 01, 2016
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provisions in § 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 https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm or
https://www.regulations.gov.
Dated: July 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–18183 Filed 8–1–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–P–0974]
Determination That SAMSCA
(Tolvaptan) Tablets, 60 Milligrams,
Were Not Withdrawn From Sale for
Reasons of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that SAMSCA (tolvaptan)
tablets, 60 milligrams (mg), were not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for tolvaptan
tablets, 60 mg, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT:
Christopher Koepke, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6214,
Silver Spring, MD 20993–0002, 240–
402–3543.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
SUMMARY:
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mstockstill on DSK3G9T082PROD with NOTICES
Federal Register / Vol. 81, No. 148 / Tuesday, August 2, 2016 / Notices
safety or effectiveness (§ 314.162 (21
CFR 314.162)).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161). FDA may not
approve an ANDA that does not refer to
a listed drug.
SAMSCA (tolvaptan) tablets, 60 mg,
are the subject of NDA 22–275, held by
Otsuka America Pharmaceutical, and
initially approved on May 19, 2009.
SAMSCA is indicated for the treatment
of clinically significant hypervolemic
and euvolemic hyponatremia (serum
sodium <125 milliequivalents/liter or
less marked hyponatremia that is
symptomatic and has resisted correction
with fluid restriction), including
patients with heart failure and
syndrome of inappropriate antidiuretic
hormone (SIADH).
Otsuka America Pharmaceutical has
never marketed SAMSCA (tolvaptan)
tablets, 60 mg. In previous instances
(see, e.g., 72 FR 9763 (March 5, 2007),
61 FR 25497 (May 21, 1996)), the
Agency has determined that, for
purposes of §§ 314.161 and 314.162,
never marketing an approved drug
product is equivalent to withdrawing
the drug from sale.
Gordon Johnston Regulatory
Consultants, LLC, submitted a citizen
petition dated March 15, 2016 (Docket
No. FDA–2016–P–0974), under 21 CFR
10.30, requesting that the Agency
determine whether SAMSCA (tolvaptan)
tablets, 60 mg, were withdrawn from
sale for reasons of safety or
effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that SAMSCA (tolvaptan)
tablets, 60 mg, were not withdrawn for
reasons of safety or effectiveness. The
petitioner has identified no data or other
information suggesting that SAMSCA
(tolvaptan) tablets, 60 mg, were
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of SAMSCA
(tolvaptan) tablets, 60 mg, from sale. We
have also independently evaluated
relevant literature and data for possible
postmarketing adverse events. We have
reviewed the available evidence and
determined that this drug product was
not withdrawn from sale for reasons of
safety or effectiveness.
VerDate Sep<11>2014
18:35 Aug 01, 2016
Jkt 238001
Accordingly, the Agency will
continue to list SAMSCA (tolvaptan)
tablets, 60 mg, in the ‘‘Discontinued
Drug Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ delineates, among other items,
drug products that have been
discontinued from marketing for reasons
other than safety or effectiveness.
ANDAs that refer to SAMSCA
(tolvaptan) tablets, 60 mg, may be
approved by the Agency as long as they
meet all other legal and regulatory
requirements for the approval of
ANDAs. If FDA determines that labeling
for this drug product should be revised
to meet current standards, the Agency
will advise ANDA applicants to submit
such labeling.
Dated: July 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–18139 Filed 8–1–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Food and Drug Administration
[Docket No. FDA–2016–D–1605]
Institutional Review Board Written
Procedures: Guidance for Institutions
and Institutional Review Boards; Draft
Guidance; Availability
The Office for Human Research
Protections, Office of the Assistant
Secretary for Health, Office of the
Secretary, HHS, and the Food and Drug
Administration, HHS.
ACTION: Notice of availability.
AGENCY:
The Office for Human
Research Protections (OHRP), Office of
the Assistant Secretary for Health, and
the Food and Drug Administration
(FDA) are announcing the availability of
a draft guidance entitled ‘‘Institutional
Review Board (IRB) Written Procedures:
Guidance for Institutions and IRBs.’’
The purpose of this draft guidance is to
assist IRB administrators, IRB
chairpersons, and other institutional
officials responsible for preparing and
maintaining written procedures for
IRBs. The draft guidance is intended for
IRBs and institutions responsible for
review and oversight of human subject
research under the HHS or FDA
regulations, or both.
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
SUMMARY:
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guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by October 3,
2016.
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): 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–1605 for ‘‘Institutional Review
Board (IRB) Written Procedures:
Guidance for Institutions and IRBs.’’
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
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
E:\FR\FM\02AUN1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 148 (Tuesday, August 2, 2016)]
[Notices]
[Pages 50710-50711]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18139]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-P-0974]
Determination That SAMSCA (Tolvaptan) Tablets, 60 Milligrams,
Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that SAMSCA (tolvaptan) tablets, 60 milligrams (mg), were
not withdrawn from sale for reasons of safety or effectiveness. This
determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for tolvaptan tablets, 60 mg, if all other legal
and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Christopher Koepke, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6214, Silver Spring, MD 20993-0002, 240-
402-3543.
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of
[[Page 50711]]
safety or effectiveness (Sec. 314.162 (21 CFR 314.162)).
A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec. 314.161). FDA may not approve an ANDA that does not refer
to a listed drug.
SAMSCA (tolvaptan) tablets, 60 mg, are the subject of NDA 22-275,
held by Otsuka America Pharmaceutical, and initially approved on May
19, 2009. SAMSCA is indicated for the treatment of clinically
significant hypervolemic and euvolemic hyponatremia (serum sodium <125
milliequivalents/liter or less marked hyponatremia that is symptomatic
and has resisted correction with fluid restriction), including patients
with heart failure and syndrome of inappropriate antidiuretic hormone
(SIADH).
Otsuka America Pharmaceutical has never marketed SAMSCA (tolvaptan)
tablets, 60 mg. In previous instances (see, e.g., 72 FR 9763 (March 5,
2007), 61 FR 25497 (May 21, 1996)), the Agency has determined that, for
purposes of Sec. Sec. 314.161 and 314.162, never marketing an approved
drug product is equivalent to withdrawing the drug from sale.
Gordon Johnston Regulatory Consultants, LLC, submitted a citizen
petition dated March 15, 2016 (Docket No. FDA-2016-P-0974), under 21
CFR 10.30, requesting that the Agency determine whether SAMSCA
(tolvaptan) tablets, 60 mg, were withdrawn from sale for reasons of
safety or effectiveness.
After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec. 314.161 that SAMSCA (tolvaptan) tablets, 60 mg, were not
withdrawn for reasons of safety or effectiveness. The petitioner has
identified no data or other information suggesting that SAMSCA
(tolvaptan) tablets, 60 mg, were withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of SAMSCA (tolvaptan) tablets, 60 mg, from
sale. We have also independently evaluated relevant literature and data
for possible postmarketing adverse events. We have reviewed the
available evidence and determined that this drug product was not
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list SAMSCA (tolvaptan)
tablets, 60 mg, in the ``Discontinued Drug Product List'' section of
the Orange Book. The ``Discontinued Drug Product List'' delineates,
among other items, drug products that have been discontinued from
marketing for reasons other than safety or effectiveness. ANDAs that
refer to SAMSCA (tolvaptan) tablets, 60 mg, may be approved by the
Agency as long as they meet all other legal and regulatory requirements
for the approval of ANDAs. If FDA determines that labeling for this
drug product should be revised to meet current standards, the Agency
will advise ANDA applicants to submit such labeling.
Dated: July 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-18139 Filed 8-1-16; 8:45 am]
BILLING CODE 4164-01-P
