Determination That CALCIMAR (calcitonin salmon) Injection, 200 International Units Per Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 47312-47313 [2019-19347]
Download as PDF
<![CDATA[
47312
Federal Register / Vol. 84, No. 174 / Monday, September 9, 2019 / Notices
outlined in this guidance are not
included in a De Novo request received
by FDA before or up to 60 days after the
publication of this guidance, FDA staff
does not generally intend to refuse to
accept.
FDA considered comments received
on the draft guidance that appeared in
the Federal Register of October 30, 2017
(82 FR 50144). FDA revised the
guidance as appropriate in response to
the comments.
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 ‘‘Acceptance
Review for De Novo Classification
Requests.’’ 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. 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. This
guidance document is also available at
https://www.regulations.gov or from the
Center for Biologics Evaluation and
Research at https://www.fda.gov/
BiologicsBloodVaccines/Guidance
ComplianceRegulatoryInformation/
IV. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information.
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 the following FDA
regulations, guidance, and forms have
been approved by OMB as listed in the
following table:
21 CFR Part; guidance; or FDA form
Topic
‘‘De Novo Classification Process (Evaluation of Automatic
Class III Designation)‘‘.
807, subpart E .........................................................................
814, subparts A through E .......................................................
800, 801, and 809 ....................................................................
3 ...............................................................................................
807, 812, and 814 ....................................................................
De Novo classification process ...............................................
0910–0844
Premarket notification .............................................................
Premarket approval .................................................................
Medical Device Labeling Regulations .....................................
Combination products; Request for Designation ....................
Human Subject Protection; Acceptance of Data from Clinical
Studies for Medical Devices.
Financial disclosure by clinical investigators ..........................
0910–0120
0910–0231
0910–0485
0910–0523
0910–0741
54 (Forms FDA 3454 and 3455) .............................................
Dated: September 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–19350 Filed 9–6–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–P–4186]
Determination That CALCIMAR
(calcitonin salmon) Injection, 200
International Units Per Milliliter, 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 or Agency) has
determined that CALCIMAR (calcitonin
salmon) Injection, 200 International
Units per milliliter (IU/mL), was not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for CALCIMAR
(calcitonin salmon) Injection, 200 IU/
SUMMARY:
jbell on DSK3GLQ082PROD with NOTICES
default.htm. Persons unable to
download an electronic copy of
‘‘Acceptance Review for De Novo
Classification Requests’’ may send an
email request to CDRH-Guidance@
fda.hhs.gov to receive an electronic
copy of the document. Please use the
document number 16055 to identify the
guidance you are requesting.
VerDate Sep<11>2014
20:43 Sep 06, 2019
Jkt 247001
mL, if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT: Nam
Kim, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6272, Silver Spring,
MD 20993–0002, 301–796–3472.
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
PO 00000
Frm 00080
Fmt 4703
Sfmt 4703
OMB control No.
0910–0396
‘‘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.
CALCIMAR (calcitonin salmon)
injection, 200 IU/mL, is the subject of
NDA 017769, held by Sanofi Aventis,
and initially approved on April 17,
1978. CALCIMAR is indicated for
Paget’s disease of bone, hypercalcemia,
and postmenopausal osteoporosis.
CALCIMAR (calcitonin salmon)
injection, 200 IU/mL, is currently listed
E:\FR\FM\09SEN1.SGM
09SEN1
Federal Register / Vol. 84, No. 174 / Monday, September 9, 2019 / Notices
in the ‘‘Discontinued Drug Product List’’
section of the Orange Book.
Lachman Consultant Services, Inc.
submitted a citizen petition dated
December 1, 2016 (Docket No. FDA–
2016–P–4186), under 21 CFR 10.30,
requesting that the Agency determine
whether CALCIMAR (calcitonin salmon)
injection, 200 IU/mL, 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 CALCIMAR (calcitonin
salmon) injection, 200 IU/mL, was not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that CALCIMAR (calcitonin
salmon) injection, 200 IU/mL, was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
CALCIMAR (calcitonin salmon)
injection, 200 IU/mL, 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 CALCIMAR (calcitonin
salmon) injection, 200 IU/mL, 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 this drug product 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.
jbell on DSK3GLQ082PROD with NOTICES
Dated: September 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–19347 Filed 9–6–19; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
20:43 Sep 06, 2019
Jkt 247001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Announcing Call for Nominations for
Members of the President’s Council on
Sports, Fitness & Nutrition Science
Board
Office of Disease Prevention
and Health Promotion, Office of the
Assistant Secretary for Health, Office of
the Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
The Department of Health and
Human Services (HHS) seeks
nominations of qualified candidates to
serve as members of the President’s
Council on Sports, Fitness & Nutrition
Science Board.
DATES: Nominations for membership on
the Science Board will be accepted
through 11:59 p.m. E.T. on October 11,
2019.
ADDRESSES: Nominations should be
submitted by email to sports@hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Katrina L. Piercy, Ph.D., R.D., Office of
Disease Prevention and Health
Promotion (ODPHP), Office of the
Assistant Secretary for Health (OASH),
HHS; 1101 Wootton Parkway, Suite 420;
Rockville, MD 20852; Telephone: (240)
453–8280. Email: odphpinfo@hhs.gov.
SUPPLEMENTARY INFORMATION: The
Science Board is a subcommittee of the
President’s Council on Sports, Fitness &
Nutrition (the Council) and is made up
of Council members and scholars with
expertise in the fields of physical
activity, health, sports, and nutrition.
The role of the Science Board is to assist
the Council by providing scientific
guidance. For the 2020–2021 term, the
Science Board will focus its efforts
around the Council’s and HHS’s
implementation and dissemination of
the National Youth Sports Strategy and
youth sports-related topics. The main
duties of the Science Board will be to:
(a) Provide subject matter expertise on
youth sports and related disciplines; (b)
draft content for publication (e.g., blogs,
peer-reviewed articles) to various
audiences highlighting specific youth
sports topics; and (c) participate
virtually in Science Board meetings and
presentations to the Council.
Nominations: HHS will consider
nominations, including selfnominations, for Science Board
members of individuals qualified to
carry out the above-mentioned tasks.
Science Board members must hold a
Ph.D., MD, or related terminal degree in
the fields of physical activity, health,
sports, and/or nutrition. The following
SUMMARY:
PO 00000
Frm 00081
Fmt 4703
Sfmt 4703
47313
information should be included in the
package of material submitted for each
individual being nominated for
consideration: (1) The name, address,
daytime telephone number, and email
address of the nominator and the
individual being nominated; (2) a letter
of nomination that clearly states the
name and affiliation of the nominee, the
basis for the nomination (i.e., specific
attributes which qualify the nominee for
service in this capacity), and a statement
from the nominee that the nominee is
willing to serve as a member of the
Science Board; and (3) a current copy of
the nominee’s curriculum vitae (CV) no
more than 10 pages in length. Inclusion
of the following is requested in the CV:
(1) Academic appointment; (2) current
and/or past grant awards; (3)
publications showing breadth and
experience in areas of specialization; (4)
paid and non-paid board and advisory
appointments; and (5) education and
occupational history.
All nominations must include the
required information. Incomplete
nominations will not be processed for
consideration. All nomination
information should be sent in a single
email, with attachments, to sports@
hhs.gov. All nominations must be
submitted by 11:59 p.m. E.T on Friday,
October 11, 2019.
Equal opportunity practices regarding
membership appointments to the
Science Board will be aligned with HHS
policies. When possible, every effort
will be made to ensure that the Science
Board is a diverse group of individuals
with representation from various
geographic locations, racial and ethnic
minorities, all genders, and persons
with disabilities. Individuals will be
appointed to serve as members of the
Science Board to represent balanced
viewpoints of the scientific evidence,
not to represent the viewpoints of any
specific group.
Dated: August 22, 2019.
Donald Wright,
Deputy Assistant Secretary for Health, Office
of Disease Prevention and Health Promotion.
[FR Doc. 2019–19384 Filed 9–6–19; 8:45 am]
BILLING CODE 4150–32–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Biomedical
Imaging and Bioengineering; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
E:\FR\FM\09SEN1.SGM
09SEN1
]]>Agencies
[Federal Register Volume 84, Number 174 (Monday, September 9, 2019)]
[Notices]
[Pages 47312-47313]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19347]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-P-4186]
Determination That CALCIMAR (calcitonin salmon) Injection, 200
International Units Per Milliliter, 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 or Agency) has
determined that CALCIMAR (calcitonin salmon) Injection, 200
International Units per milliliter (IU/mL), was not withdrawn from sale
for reasons of safety or effectiveness. This determination will allow
FDA to approve abbreviated new drug applications (ANDAs) for CALCIMAR
(calcitonin salmon) Injection, 200 IU/mL, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Nam Kim, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6272, Silver Spring, MD 20993-0002, 301-796-3472.
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 (Sec. 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
CALCIMAR (calcitonin salmon) injection, 200 IU/mL, is the subject
of NDA 017769, held by Sanofi Aventis, and initially approved on April
17, 1978. CALCIMAR is indicated for Paget's disease of bone,
hypercalcemia, and postmenopausal osteoporosis.
CALCIMAR (calcitonin salmon) injection, 200 IU/mL, is currently
listed
[[Page 47313]]
in the ``Discontinued Drug Product List'' section of the Orange Book.
Lachman Consultant Services, Inc. submitted a citizen petition
dated December 1, 2016 (Docket No. FDA-2016-P-4186), under 21 CFR
10.30, requesting that the Agency determine whether CALCIMAR
(calcitonin salmon) injection, 200 IU/mL, 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 CALCIMAR (calcitonin salmon) injection, 200
IU/mL, was not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
CALCIMAR (calcitonin salmon) injection, 200 IU/mL, was withdrawn for
reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of CALCIMAR (calcitonin
salmon) injection, 200 IU/mL, 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 CALCIMAR (calcitonin
salmon) injection, 200 IU/mL, 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 this drug product 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: September 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-19347 Filed 9-6-19; 8:45 am]
BILLING CODE 4164-01-P
