Determination That MIOCHOL (Acetylcholine Chloride Intraocular Solution), 20 Milligrams/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 33951-33952 [2019-15089]
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(section 121(c)) by developing
appropriate procedures for the approval
of PET drugs in accordance with section
505 of the FD&C Act (21 U.S.C. 355) and
to establish current good manufacturing
practice requirements for PET drugs.
Within FDAMA, Congress recognized
the unique characteristics of PET
drugs—in particular, the special criteria
and processes required to produce these
drugs—directing the Secretary of Health
and Human Services to take due
account of any relevant differences
between not-for profit institutions that
compound the drugs for their patients
and commercial manufacturers of the
drugs. See section 121(c)(1)(B) of
FDAMA.
Statements like this indicate that one
of Congress’ goals in enacting section
121 of FDAMA was to promote the
availability of FDA-approved PET drug
products for the patients who need
them. Previously, FDA found that,
because of the unique circumstances
surrounding the regulation of PET drug
products, assessment of an application
fee on certain PET drugs would present
a significant barrier to innovation, and
FDA granted a waiver of application
fees for certain PET drug products.1
Similarly, FDA believes that the
requirement to submit applications in
eCTD format could result in a
significant burden on certain PET drug
producers and may lead to reduced
availability of these innovative and
lifesaving diagnostic drugs. This
guidance proposes that sponsors and
applicants of PET drug products may
request a waiver from complying with
eCTD submission requirements if they
meet certain factors set forth in the
revised eCTD guidance. Although FDA
proposes waiving eCTD requirements
for these submissions, FDA continues to
recommend use of the eCTD format for
PET drug products if feasible. The
Agency is issuing this revision to its
guidance to propose this waiver.
Certain Type II DMFs. Type II DMFs
are submitted to the Agency to make
quality information available for Agency
evaluation of the quality of active
pharmaceutical ingredients and drug
products used in investigational studies.
Many such studies are conducted by
academic, non-commercial sponsors
where there is no commercial objective
to support these applications. In some
cases, the Type II DMF submission may
be submitted by the academic sponsor
or by a second party. For these academic
IND sponsors, compliance with eCTD
1 https://www.federalregister.gov/documents/
2000/03/10/00-5865/positron-emissiontomography-drug-products-safety-and-effectivenessof-certain-pet-drugs-for.
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submission requirements can represent
a significant burden and may present an
obstacle to the conduct of research.
After consideration of this regulatory
burden and the potential negative
impact on research and innovation, FDA
proposes to waive the requirement to
comply with eCTD submission
requirements for certain Type II DMF
submissions from an academic
institution, government (State or
Federal), or a non-profit research
organization that are solely supporting a
noncommercial application.
Short-Term Waivers. This guidance
also describes the circumstances in
which FDA proposes granting a
temporary waiver from complying with
eCTD submission requirements and the
procedures for submitting requests for
waivers.
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 ‘‘Providing Regulatory Submissions
in Electronic Format—Certain Human
Pharmaceutical Product Applications
and Related Submissions Using the
eCTD Specifications (Revision 7).’’
FDA guidances ordinarily contain
standard language explaining that
guidances should be viewed only as
recommendations unless specific
regulatory or statutory requirements are
cited. FDA is not including this
standard language in this guidance
because this guidance contains binding
provisions. In section 745A(a) of the
FD&C Act (21 U.S.C. 379k–1), Congress
granted explicit authorization to FDA to
specify in guidance the format for the
electronic submissions required under
that section and required that FDA
‘‘shall’’ issue such guidance.
Accordingly, this guidance explains
such requirements under section
745A(a) of the FD&C Act, indicated by
the use of the words must or required,
and therefore is not subject to the usual
restrictions in FDA’s good guidance
practice regulations, such as the
requirement that guidances not establish
legally enforceable responsibilities. See
e.g., 21 CFR 10.115(d).
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information that
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 parts 312, 314,
and 601 have been approved under
OMB control numbers 0910–0014,
0910–0001, 0910–0338, and 0910–0308.
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33951
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm, or
https://www.regulations.gov.
Dated: July 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–15103 Filed 7–15–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–P–0372]
Determination That MIOCHOL
(Acetylcholine Chloride Intraocular
Solution), 20 Milligrams/Vial, Was Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we)
has determined that MIOCHOL
(acetylcholine chloride intraocular
solution), 20 milligrams (mg)/vial, was
not withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for acetylcholine
chloride intraocular solution, 20 mg/
vial, if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT:
Meadow Platt, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6224,
Silver Spring, MD 20993–0002, 301–
796–1830.
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
SUMMARY:
E:\FR\FM\16JYN1.SGM
16JYN1
jspears on DSK30JT082PROD with NOTICES
33952
Federal Register / Vol. 84, No. 136 / Tuesday, July 16, 2019 / Notices
do not have to repeat the 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
safety or effectiveness (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 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
MIOCHOL (acetylcholine chloride
intraocular solution), 20 mg/vial, is the
subject of NDA 016211, held by
Novartis Pharmaceutical Corporation
(Novartis). MIOCHOL is indicated to
obtain complete miosis of the iris in
seconds after delivery of the lens in
cataract surgery, in penetrating
keratoplasty, iridectomy, and other
anterior segment surgery where rapid,
complete miosis may be required.
In a letter dated January 18, 2006,
Novartis requested withdrawal of NDA
016211 for MIOCHOL (acetylcholine
chloride intraocular solution). In the
Federal Register of July 12, 2018 (83 FR
32305), FDA announced that it was
withdrawing approval of NDA 016211,
effective August 13, 2018.
Hyman, Phelps & McNamara, P.C.,
submitted a citizen petition dated
January 23, 2019, under 21 CFR 10.30,
requesting that the Agency determine
whether MIOCHOL (acetylcholine
chloride intraocular solution), 20 mg/
vial, was 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 MIOCHOL (acetylcholine
chloride intraocular solution), 20 mg/
vial, was not withdrawn for reasons of
safety or effectiveness. The petitioner
has identified no data or other
information suggesting that MIOCHOL
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Jkt 247001
(acetylcholine chloride intraocular
solution), 20 mg/vial, was withdrawn
for reasons of safety or effectiveness. We
have carefully reviewed our files for
records concerning the withdrawal of
MIOCHOL (acetylcholine chloride
intraocular solution), 20 mg/vial, 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 MIOCHOL
(acetylcholine chloride intraocular
solution), 20 mg/vial, 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 MIOCHOL (acetylcholine chloride
intraocular solution), 20 mg/vial, 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 9, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–15089 Filed 7–15–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0117]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry on Hypertension Indication:
Drug Labeling for Cardiovascular
Outcome Claims
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
SUMMARY:
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proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection associated with the FDA
‘‘Guidance for Industry on Hypertension
Indication: Drug Labeling for
Cardiovascular Outcome Claims,’’
which is intended to assist applicants in
developing labeling for outcome claims
for drugs that are indicated to treat
hypertension.
Submit either electronic or
written comments on the collection of
information by September 16, 2019.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before September 16,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of September 16, 2019.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
DATES:
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:
E:\FR\FM\16JYN1.SGM
16JYN1
Agencies
[Federal Register Volume 84, Number 136 (Tuesday, July 16, 2019)]
[Notices]
[Pages 33951-33952]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15089]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-P-0372]
Determination That MIOCHOL (Acetylcholine Chloride Intraocular
Solution), 20 Milligrams/Vial, Was 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, Agency, or we) has
determined that MIOCHOL (acetylcholine chloride intraocular solution),
20 milligrams (mg)/vial, was not withdrawn from sale for reasons of
safety or effectiveness. This determination will allow FDA to approve
abbreviated new drug applications (ANDAs) for acetylcholine chloride
intraocular solution, 20 mg/vial, if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT: Meadow Platt, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6224, Silver Spring, MD 20993-0002, 301-
796-1830.
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
[[Page 33952]]
do not have to repeat the 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 safety or effectiveness (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 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
MIOCHOL (acetylcholine chloride intraocular solution), 20 mg/vial,
is the subject of NDA 016211, held by Novartis Pharmaceutical
Corporation (Novartis). MIOCHOL is indicated to obtain complete miosis
of the iris in seconds after delivery of the lens in cataract surgery,
in penetrating keratoplasty, iridectomy, and other anterior segment
surgery where rapid, complete miosis may be required.
In a letter dated January 18, 2006, Novartis requested withdrawal
of NDA 016211 for MIOCHOL (acetylcholine chloride intraocular
solution). In the Federal Register of July 12, 2018 (83 FR 32305), FDA
announced that it was withdrawing approval of NDA 016211, effective
August 13, 2018.
Hyman, Phelps & McNamara, P.C., submitted a citizen petition dated
January 23, 2019, under 21 CFR 10.30, requesting that the Agency
determine whether MIOCHOL (acetylcholine chloride intraocular
solution), 20 mg/vial, was 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 MIOCHOL (acetylcholine chloride intraocular
solution), 20 mg/vial, was not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that MIOCHOL (acetylcholine chloride intraocular
solution), 20 mg/vial, was withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of MIOCHOL (acetylcholine chloride
intraocular solution), 20 mg/vial, 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 MIOCHOL
(acetylcholine chloride intraocular solution), 20 mg/vial, 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 MIOCHOL
(acetylcholine chloride intraocular solution), 20 mg/vial, 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 9, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15089 Filed 7-15-19; 8:45 am]
BILLING CODE 4164-01-P