Determination That PROLIXIN (Fluphenazine Hydrochloride) Tablets, 1 Milligram, 2.5 Milligrams, 5 Milligrams, and 10 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 39453-39454 [2018-17026]
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Federal Register / Vol. 83, No. 154 / Thursday, August 9, 2018 / Notices
on the label (2,160 ¥ 1,140 = 1,020
products not organics; 540 ¥ 285 = 255
manufacturers of not organic products).
In addition, the 54 livestock feed
suppliers are also organic producers,
thus the 216 products attributed to these
manufacturers already are considered to
be labeled ‘‘organic.’’ Thus, there are
1,020 products made by 255 human
food and pet food manufacturers that
would need to substantiate that their
product or ingredient was not
genetically engineered.
We estimate that the burden of
maintaining the documentation is a onetime burden; the document to
substantiate that the product or
ingredient was produced without
genetic engineering only needs to be
generated once and then kept on file. To
annualize this one-time burden, we
divide by 3 because paperwork burden
collections are approved on a 3-year
cycle (255/3 = 85). Thus, we estimate in
table 1 that, on average, 85
manufacturers annually will collect and
keep information that substantiates their
label claim for four products (1,020
products/3 = 340 products/85
manufacturers = 4 products per
manufacturer).
We estimate this one-time
recordkeeping burden to be 1 hour per
product that makes use of a labeling
claim, which results in a burden of 1
hour for a total annualized
recordkeeping burden of 340 hours (85
manufacturers × 4 records per
manufacturer × 1 hour per record).
We do not estimate any reporting
burden or third-party disclosure burden
associated with this information
collection. Manufacturers who want to
make use of this voluntary labeling
claim option are considered to be those
that already have such wording on their
products’ labels. We do not expect that
this guidance will cause labels already
in the marketplace to need to be
reworded.
Dated: August 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–17024 Filed 8–8–18; 8:45 am]
sradovich on DSK3GMQ082PROD with NOTICES
BILLING CODE 4164–01–P
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18:11 Aug 08, 2018
Jkt 244001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–P–0998]
Determination That PROLIXIN
(Fluphenazine Hydrochloride) Tablets,
1 Milligram, 2.5 Milligrams, 5
Milligrams, and 10 Milligrams, 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 PROLIXIN
(fluphenazine hydrochloride) tablets, 1
milligram (mg), 2.5 mg, 5 mg, and 10
mg, was not withdrawn from sale for
reasons of safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for fluphenazine
hydrochloride tablets, 1 mg, 2.5 mg, 5
mg, and 10 mg, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT:
Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6236, Silver Spring,
MD 20993–0002, 301–796–8363,
Stacy.Kane@fda.hhs.gov.
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 an 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
SUMMARY:
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
39453
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.
PROLIXIN (fluphenazine
hydrochloride) tablets, 1 mg, 2.5 mg, 5
mg, and 10 mg, is the subject of NDA
011751, held by Apothecon
Pharmaceuticals, a Bristol-Myers Squibb
Company, and initially approved on
March 15, 1967. PROLIXIN is indicated
in the management of manifestations of
psychotic disorders.
In a letter dated October 5, 2006,
Bristol-Myers Squibb Company
requested withdrawal of NDA 011751
for PROLIXIN (fluphenazine
hydrochloride) tablets, 1 mg, 2.5 mg, 5
mg, and 10 mg. In the Federal Register
of February 11, 2009 (74 FR 6896), FDA
announced that it was withdrawing
approval of NDA 011751, effective
March 13, 2009.
Hyman, Phelps & McNamara, P.C.
submitted a citizen petition dated
March 5, 2018 (Docket No. FDA–2018–
P–0998), under 21 CFR 10.30,
requesting that the Agency determine
whether PROLIXIN (fluphenazine
hydrochloride) tablets, 1 mg, 2.5 mg, 5
mg, and 10 mg, 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 PROLIXIN (fluphenazine
hydrochloride) tablets, 1 mg, 2.5 mg, 5
mg, and 10 mg, was not withdrawn for
reasons of safety or effectiveness. The
petitioner has identified no data or other
information suggesting that PROLIXIN
(fluphenazine hydrochloride) tablets, 1
mg, 2.5 mg, 5 mg, and 10 mg, was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of PROLIXIN
(fluphenazine hydrochloride) tablets, 1
mg, 2.5 mg, 5 mg, and 10 mg, from sale.
We have also independently evaluated
relevant literature and data for possible
postmarketing adverse events. We have
found no information that would
indicate that this drug product was
E:\FR\FM\09AUN1.SGM
09AUN1
39454
Federal Register / Vol. 83, No. 154 / Thursday, August 9, 2018 / Notices
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list PROLIXIN
(fluphenazine hydrochloride) tablets, 1
mg, 2.5 mg, 5 mg, and 10 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 PROLIXIN (fluphenazine
hydrochloride) tablets, 1 mg, 2.5 mg, 5
mg, and 10 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 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–17026 Filed 8–8–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The invention listed below is
owned by an agency of the U.S.
Government and is available for
licensing to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
FOR FURTHER INFORMATION CONTACT:
Amy F. Petrik, Ph.D., 240–627–3721,
amy.petrik@nih.gov. Licensing
information and copies of the U.S.
patent application listed below may be
obtained by communicating with the
indicated licensing contact at the
Technology Transfer and Intellectual
Property Office, National Institute of
Allergy and Infectious Diseases, 5601
Fishers Lane, Rockville, MD 20852; tel.
301–496–2644. A signed Confidential
Disclosure Agreement will be required
to receive copies of unpublished patent
applications.
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:11 Aug 08, 2018
Jkt 244001
SUPPLEMENTARY INFORMATION:
Technology description follows.
Stabilized Group 2 Influenza
Hemagglutinin Stem Region Trimers
and Uses Thereof
Description of Technology:
Researchers at the Vaccine Research
Center of the National Institute of
Allergy and Infectious Diseases (NIAID)
have designed influenza vaccine
candidates based on group 2 influenza
hemagglutinin (HA) proteins. These
group 2 HA proteins were engineered to
remove the highly variable head region
and stabilize the remaining stem region.
The researchers then fused the
engineered group 2 HA stabilized stem
with a ferritin subunit. The resulting
fusion protein can self-assemble into
nanoparticles which display group 2 HA
stem domain trimers on their surface.
These immunogens elicit crossreactive antibodies to group 2 influenza
viruses and could be used in
combination with group 1 HA stemferritin immunogens as a universal
influenza vaccine. Interestingly, a recent
study by Andrews et al., Sci. Immunol.
2, eaan2676 (2017), suggests that crossreactive group 1/group 2 HA stem
antibodies may be more likely to be
elicited in humans by a group 2 HA
immunogen.
This technology is available for
licensing for commercial development
in accordance with 35 U.S.C. 209 and 37
CFR part 404.
Potential Commercial Applications:
• Use as a broadly protective influenza
vaccine
Competitive Advantages:
• Elicits antibodies to both group 1 and
group 2 influenza A viruses
• Nucleic acid or recombinant proteinbased vaccine
• Increased ease of production
compared to current seasonal
influenza vaccines
Development Stage:
• In vivo (animal studies)
Inventors: Jeffrey C. Boyington,
Barney S. Graham, John R. Mascola,
Hadi M. Yassine, Syed M. Moin,
Lingshu Wang, Kizzmekia S. Corbett,
Masaru Kanekiyo (all from NIAID).
Intellectual Property: HHS Reference
Number E–228–2016 includes U.S.
Provisional 62/383,267 filed 2
September 2016 and PCT Patent
Application No. PCT/US2017/049894
filed 1 September 2017 (pending).
Related Intellectual Property: HHS
Reference Number E–293–2011.
Licensing Contact: Dr. Amy Petrik,
240–627–3721; amy.petrik@nih.gov.
PO 00000
Frm 00053
Fmt 4703
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Dated: July 25, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2018–17036 Filed 8–8–18; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
[1651–0138]
Agency Information Collection
Activities: Biometric Identity
U.S. Customs and Border
Protection (CBP), Department of
Homeland Security.
ACTION: 30-Day notice and request for
comments; revision and extension of an
existing collection of information.
AGENCY:
The Department of Homeland
Security, U.S. Customs and Border
Protection will be submitting the
following information collection request
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act of 1995 (PRA). The
information collection is published in
the Federal Register to obtain comments
from the public and affected agencies.
DATES: Comments are encouraged and
will be accepted (no later than
September 10, 2018]) to be assured of
consideration.
ADDRESSES: Interested persons are
invited to submit written comments on
this proposed information collection to
the Office of Information and Regulatory
Affairs, Office of Management and
Budget. Comments should be addressed
to the OMB Desk Officer for Customs
and Border Protection, Department of
Homeland Security, and sent via
electronic mail to dhsdeskofficer@
omb.eop.gov.
FOR FURTHER INFORMATION CONTACT:
Requests for additional PRA information
should be directed to Seth Renkema,
Chief, Economic Impact Analysis
Branch, U.S. Customs and Border
Protection, Office of Trade, Regulations
and Rulings, 90 K Street NE, 10th Floor,
Washington, DC 20229–1177,
Telephone number (202) 325–0056 or
via email CBP_PRA@cbp.dhs.gov. Please
note that the contact information
provided here is solely for questions
regarding this notice. Individuals
seeking information about other CBP
programs should contact the CBP
National Customer Service Center at
877–227–5511, (TTY) 1–800–877–8339,
SUMMARY:
E:\FR\FM\09AUN1.SGM
09AUN1
]]>Agencies
[Federal Register Volume 83, Number 154 (Thursday, August 9, 2018)]
[Notices]
[Pages 39453-39454]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17026]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-P-0998]
Determination That PROLIXIN (Fluphenazine Hydrochloride) Tablets,
1 Milligram, 2.5 Milligrams, 5 Milligrams, and 10 Milligrams, 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 PROLIXIN (fluphenazine hydrochloride) tablets, 1
milligram (mg), 2.5 mg, 5 mg, and 10 mg, was not withdrawn from sale
for reasons of safety or effectiveness. This determination will allow
FDA to approve abbreviated new drug applications (ANDAs) for
fluphenazine hydrochloride tablets, 1 mg, 2.5 mg, 5 mg, and 10 mg, if
all other legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363,
[email protected].
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 an 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.
PROLIXIN (fluphenazine hydrochloride) tablets, 1 mg, 2.5 mg, 5 mg,
and 10 mg, is the subject of NDA 011751, held by Apothecon
Pharmaceuticals, a Bristol-Myers Squibb Company, and initially approved
on March 15, 1967. PROLIXIN is indicated in the management of
manifestations of psychotic disorders.
In a letter dated October 5, 2006, Bristol-Myers Squibb Company
requested withdrawal of NDA 011751 for PROLIXIN (fluphenazine
hydrochloride) tablets, 1 mg, 2.5 mg, 5 mg, and 10 mg. In the Federal
Register of February 11, 2009 (74 FR 6896), FDA announced that it was
withdrawing approval of NDA 011751, effective March 13, 2009.
Hyman, Phelps & McNamara, P.C. submitted a citizen petition dated
March 5, 2018 (Docket No. FDA-2018-P-0998), under 21 CFR 10.30,
requesting that the Agency determine whether PROLIXIN (fluphenazine
hydrochloride) tablets, 1 mg, 2.5 mg, 5 mg, and 10 mg, 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 PROLIXIN (fluphenazine hydrochloride) tablets,
1 mg, 2.5 mg, 5 mg, and 10 mg, was not withdrawn for reasons of safety
or effectiveness. The petitioner has identified no data or other
information suggesting that PROLIXIN (fluphenazine hydrochloride)
tablets, 1 mg, 2.5 mg, 5 mg, and 10 mg, was withdrawn for reasons of
safety or effectiveness. We have carefully reviewed our files for
records concerning the withdrawal of PROLIXIN (fluphenazine
hydrochloride) tablets, 1 mg, 2.5 mg, 5 mg, and 10 mg, from sale. We
have also independently evaluated relevant literature and data for
possible postmarketing adverse events. We have found no information
that would indicate that this drug product was
[[Page 39454]]
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list PROLIXIN
(fluphenazine hydrochloride) tablets, 1 mg, 2.5 mg, 5 mg, and 10 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 PROLIXIN
(fluphenazine hydrochloride) tablets, 1 mg, 2.5 mg, 5 mg, and 10 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 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-17026 Filed 8-8-18; 8:45 am]
BILLING CODE 4164-01-P
