Determination That RITALIN LA (Methylphenidate Hydrochloride) Extended-Release Capsules, 60 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 42103-42104 [2017-18817]
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Federal Register / Vol. 82, No. 171 / Wednesday, September 6, 2017 / Notices
provides recommendations for the
content of premarket submissions and
labeling for such devices.
In the Federal Register of January 26,
2016 (81 FR 4303), FDA announced the
availability of the draft of this guidance
and interested persons were invited to
comment by March 28, 2016. The
comment period was extended on
February 23, 2016 (81 FR 8966), to April
28, 2016. FDA has considered all of the
public comments received in finalizing
this guidance.
FDA recognizes and anticipates that
the Agency and industry may need up
to 60 days to perform activities to
operationalize the policies within the
guidance. If new information regarding
device interoperability as outlined in
this guidance is not included in a
premarket submission received by FDA
before or up to 60 days after the
publication of this guidance, CDRH staff
does not generally intend to request
such information during the review of
the submission. CDRH does, however,
intend to review any such information
if submitted.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
II. Significance of Guidance
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Design
Considerations and Premarket
Submission Recommendations for
Interoperable Medical Devices.’’ 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.
III. 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
21 CFR part 820 have been approved
under OMB control number 0910–0073;
the collections of information in 21 CFR
part 812 have been approved under
OMB control number 0910–0078; the
collections of information in 21 CFR
part 807, subpart E, have been approved
under OMB control number 0910–0120;
the collections of information in 21 CFR
part 814, subparts A through E, have
been approved under OMB control
number 0910–0231; the collections of
information in 21 CFR part 814, subpart
H have been approved under OMB
VerDate Sep<11>2014
17:37 Sep 05, 2017
Jkt 241001
control number 0910–0332; 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
parts 801 and 809 have been approved
under OMB control number 0910–0485;
and the collections of information in 21
CFR parts 610 and 660 have been
approved under OMB control number
0910–0338.
IV. Electronic Access
Persons interested in obtaining a copy
of the guidance may do so by
downloading an electronic copy from
the Internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.fda.gov/BiologicsBlood
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RegulatoryInformation/default.htm or
https://www.regulations.gov. Persons
unable to download an electronic copy
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Premarket Submission
Recommendations for Interoperable
Medical Devices’’ may send an email
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to receive an electronic copy of the
document. Please use the document
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guidance you are requesting.
Dated: August 30, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–18815 Filed 9–5–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–P–2496]
Determination That RITALIN LA
(Methylphenidate Hydrochloride)
Extended-Release Capsules, 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 RITALIN LA
(methylphenidate hydrochloride)
extended-release capsules, 60
milligrams (mg), were not withdrawn
from sale for reasons of safety or
effectiveness. This determination will
SUMMARY:
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
42103
allow FDA to approve abbreviated new
drug applications (ANDAs) for
methylphenidate hydrochloride
extended-release capsules, 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. 6224,
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
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 (21 CFR 314.161). FDA may
not approve an ANDA that does not
refer to a listed drug.
RITALIN LA (methylphenidate
hydrochloride) extended-release
capsules, 60 mg, are the subject of NDA
021284, held by Novartis
Pharmaceuticals Corp. (Novartis) and
initially approved on October 27, 2014.
RITALIN LA is indicated for the
E:\FR\FM\06SEN1.SGM
06SEN1
asabaliauskas on DSKBBXCHB2PROD with NOTICES
42104
Federal Register / Vol. 82, No. 171 / Wednesday, September 6, 2017 / Notices
treatment of Attention Deficit
Hyperactivity Disorder (ADHD).
In a letter dated March 23, 2016,
Novartis notified FDA that RITALIN LA
(methylphenidate hydrochloride)
extended-release capsules, 60 mg, were
being discontinued, and FDA moved the
drug product to the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book.
Abhai, LLC, submitted a citizen
petition dated April 19, 2017 (Docket
No. FDA–2017–P–2496), under 21 CFR
10.30, requesting that the Agency
determine whether RITALIN LA
(methylphenidate hydrochloride)
extended-release capsules, 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 RITALIN LA
(methylphenidate hydrochloride)
extended-release capsules, 60 mg, were
not withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that RITALIN LA
(methylphenidate hydrochloride)
extended-release capsules, 60 mg, were
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of RITALIN
LA (methylphenidate hydrochloride)
extended-release capsules, 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 RITALIN LA
(methylphenidate hydrochloride)
extended-release capsules, 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 RITALIN LA (methylphenidate
hydrochloride) extended-release
capsules, 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.
VerDate Sep<11>2014
17:37 Sep 05, 2017
Jkt 241001
Dated: August 28, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–18817 Filed 9–5–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Aging Initial Review Group; Clinical Aging
Review Committee.
Date: October 5–6, 2017.
Time: 3:30 p.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda Marriott, 5151 Pooks Hill
Road, Bethesda, MD 20814.
Contact Person: Alicja L. Markowska,
Ph.D., DSC, National Institute on Aging,
National Institutes of Health, Gateway
Building 2C212, 7201 Wisconsin Avenue,
Bethesda, MD 20892, 301–496–9666,
markowsa@nia.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: August 30, 2017.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–18805 Filed 9–5–17; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the National Cancer
Advisory Board, September 12, 2017,
1:00 p.m. to September 12, 2017, 4:00
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
p.m., National Cancer Institute—Shady
Grove, 9609 Medical Center Drive,
Conference Room TE406 and TE408,
Rockville, MD, 20850 (Virtual Meeting)
which was published in the Federal
Register on August 14, 2017, 82 FR
37885.
The meeting notice is amended to
change the times of the open and closed
sessions. The open session will end at
2:15 p.m. The closed session will begin
at 2:30 p.m. and end at 3:30 p.m. The
meeting is partially closed to the public.
Dated: August 30, 2017.
Melanie J. Pantoja,
Program Analyst Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–18804 Filed 9–5–17; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; PAR–15–067:
NIDDK Multi-Center Clinical Study
Cooperative Agreement (U01): CKD and Bone
Mineral Disorders in Children.
Date: October 2, 2017.
Time: 11:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate
cooperative agreement applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Najma S. Begum, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 7349, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, (301) 594–8894,
begumn@niddk.nih.gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel, PAR–16–126: High
Impact, Interdisciplinary Science in NIDDK
E:\FR\FM\06SEN1.SGM
06SEN1
]]>Agencies
[Federal Register Volume 82, Number 171 (Wednesday, September 6, 2017)]
[Notices]
[Pages 42103-42104]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-18817]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-P-2496]
Determination That RITALIN LA (Methylphenidate Hydrochloride)
Extended-Release Capsules, 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 RITALIN LA (methylphenidate hydrochloride) extended-
release capsules, 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
methylphenidate hydrochloride extended-release capsules, 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. 6224, 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 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 (21 CFR 314.161). FDA may not approve an ANDA that does not refer
to a listed drug.
RITALIN LA (methylphenidate hydrochloride) extended-release
capsules, 60 mg, are the subject of NDA 021284, held by Novartis
Pharmaceuticals Corp. (Novartis) and initially approved on October 27,
2014. RITALIN LA is indicated for the
[[Page 42104]]
treatment of Attention Deficit Hyperactivity Disorder (ADHD).
In a letter dated March 23, 2016, Novartis notified FDA that
RITALIN LA (methylphenidate hydrochloride) extended-release capsules,
60 mg, were being discontinued, and FDA moved the drug product to the
``Discontinued Drug Product List'' section of the Orange Book.
Abhai, LLC, submitted a citizen petition dated April 19, 2017
(Docket No. FDA-2017-P-2496), under 21 CFR 10.30, requesting that the
Agency determine whether RITALIN LA (methylphenidate hydrochloride)
extended-release capsules, 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 RITALIN LA (methylphenidate
hydrochloride) extended-release capsules, 60 mg, were not withdrawn for
reasons of safety or effectiveness. The petitioner has identified no
data or other information suggesting that RITALIN LA (methylphenidate
hydrochloride) extended-release capsules, 60 mg, were withdrawn for
reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of RITALIN LA
(methylphenidate hydrochloride) extended-release capsules, 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 RITALIN LA
(methylphenidate hydrochloride) extended-release capsules, 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 RITALIN LA
(methylphenidate hydrochloride) extended-release capsules, 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: August 28, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-18817 Filed 9-5-17; 8:45 am]
BILLING CODE 4164-01-P
