Training Program for Regulatory Project Managers; Information Available to Industry, 12624-12625 [2019-06327]
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Federal Register / Vol. 84, No. 63 / Tuesday, April 2, 2019 / Notices
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, 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–
2019–N–1215 for ‘‘Post-Marketing
Pediatric-Focused Product Safety
Reviews; Establishment of a Public
Docket; Request for Comments.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ FDA
will review this copy, including the
claimed confidential information, in its
consideration of comments. The second
copy, which will have the claimed
confidential information redacted/
blacked out, will be available for public
viewing and posted on https://
www.regulations.gov. Submit both
copies to the Dockets Management Staff.
If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
VerDate Sep<11>2014
18:45 Apr 01, 2019
Jkt 247001
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Amy Odegaard, Office of the
Commissioner, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5151, Silver Spring,
MD 20993, 301–796–8627,
amy.odegaard@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
responsible for protecting the public
health by assuring the safety, efficacy,
and security of human and veterinary
drugs, biological products, medical
devices, our Nation’s food supply,
cosmetics, and products that emit
radiation. FDA also has responsibility
for regulating the manufacturing,
marketing, and distribution of tobacco
products to protect the public health
and to reduce tobacco use by minors.
FDA has established a public docket,
Docket No. FDA–2019–N–1215, to
receive input on post-marketing
pediatric-focused safety reviews of
products posted between October 12,
2018, and April 1, 2019, available on
FDA’s website at https://www.fda.gov/
AdvisoryCommittees/
CommitteesMeetingMaterials/
PediatricAdvisoryCommittee/
ucm510701.htm but not presented at the
April 8, 2019, PAC meeting. FDA
welcomes comments by members of the
PAC, as mandated by the Best
Pharmaceuticals for Children Act (Pub.
L. 107–109) and the Pediatric Research
Equity Act of 2003 (Pub. L. 108–155),
interested parties (such as academic
researchers, regulated industries,
consortia, and patient groups), and the
general public. The docket number is
FDA–2019–N–1215. The docket will
open on April 2, 2019, and remain open
until April 15, 2019. The post-marketing
pediatric-focused safety reviews are for
the following products from the
following centers at FDA:
Center for Biologics Evaluation and
Research
1. ADYNOVATE (Antihemophilic
Factor [recombinant])
2. IXINITY (Coagulation Factor IX
[Recombinant])
3. EPICEL (cultured epidermal
autografts) (Humanitarian Device
Exemption [HDE])
Center for Drug Evaluation and
Research
1. ACZONE GEL (dapsone)
2. AIRDUO RESPICLICK (fluticasone
propionate and salmeterol) and
ARMONAIR RESPICLICK
(fluticasone propionate)
3. AVELOX (moxifloxacin
hydrochloride)
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Fmt 4703
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4. CALDOLOR INJECTION (ibuprofen)
5. CUBICIN INJECTION (daptomycin)
6. DEXILANT (dexlansoprazole)
7. EUCRISA OINTMENT (crisaborole)
8. LILETTA (levonorgestrel-releasing
intrauterine system)
9. LYRICA (pregabalin)
10. NARCAN NASAL SPRAY (naloxone
hydrochloride)
11. OFIRMEV (acetaminophen)
12. SELZENTRY (maraviroc)
13. SPIRIVA RESPIMAT (tiotropium
bromide)
14. SYMBICORT INHALATION
AEROSOL (budesonide/formoterol
fumarate dehydrate)
15. TARCEVA (erlotinib hydrochloride)
16. VELCADE (bortezomib)
Center for Devices and Radiological
Health
1. FLOURISHTM PEDIATRIC
ESOPHAGEAL ATRESIA DEVICE
(HDE)
2. LIPOSORBER LA–15 SYSTEM (HDE)
3. MEDTRONIC ACTIVA DYSTONIA
THERAPY (HDE)
Dated: March 28, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–06385 Filed 4–1–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0179]
Training Program for Regulatory
Project Managers; Information
Available to Industry
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration’s (FDA or the Agency)
Center for Drug Evaluation and Research
(CDER) is announcing the continuation
of the Regulatory Project Management
Site Tours and Regulatory Interaction
Program (the Site Tours Program). The
purpose of this document is to invite
pharmaceutical companies interested in
participating in this program to contact
CDER.
DATES: Pharmaceutical companies may
send proposed agendas to the Agency by
June 3, 2019.
FOR FURTHER INFORMATION CONTACT: Dan
Brum, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 5480, Silver Spring,
MD 20993–0002, 301–796–0578,
dan.brum@fda.hhs.gov.
SUMMARY:
E:\FR\FM\02APN1.SGM
02APN1
Federal Register / Vol. 84, No. 63 / Tuesday, April 2, 2019 / Notices
SUPPLEMENTARY INFORMATION:
amozie on DSK9F9SC42PROD with NOTICES
I. Background
An important part of CDER’s
commitment to make safe and effective
drugs available to all Americans is
optimizing the efficiency and quality of
the drug review process. To support this
goal, CDER has initiated various training
and development programs to promote
high performance in its regulatory
project management staff. CDER seeks to
enhance review efficiency and review
quality by providing the staff with a
better understanding of the
pharmaceutical industry and its
operations. To this end, CDER is
continuing its training program to give
regulatory project managers the
opportunity to tour pharmaceutical
facilities. The goals are to provide the
following: (1) Firsthand exposure to
industry’s drug development processes
and (2) a venue for sharing information
about project management procedures
(but not drug-specific information) with
industry representatives.
II. The Site Tours Program
In this program, over a 2- to 3-day
period, small groups (five or less) of
CDER regulatory project managers,
including a senior level regulatory
project manager, can observe operations
of pharmaceutical manufacturing and/or
packaging facilities, pathology/
toxicology laboratories, and regulatory
affairs operations. Neither this tour nor
any part of the program is intended as
a mechanism to inspect, assess, judge,
or perform a regulatory function, but is
meant rather to improve mutual
understanding and to provide an avenue
for open dialogue. During the Site Tours
Program, regulatory project managers
will also participate in daily workshops
with their industry counterparts,
focusing on selective regulatory issues
important to both CDER staff and
industry. The primary objective of the
daily workshops is to learn about the
team approach to drug development,
including drug discovery, preclinical
evaluation, tracking mechanisms, and
regulatory submission operations. The
overall benefit to regulatory project
managers will be exposure to project
management, team techniques, and
processes employed by the
pharmaceutical industry. By
participating in this program, the
regulatory project manager will grow
professionally by gaining a better
understanding of industry processes and
procedures.
III. Site Selection
All travel expenses associated with
the Site Tours Program will be the
VerDate Sep<11>2014
18:45 Apr 01, 2019
Jkt 247001
responsibility of CDER; therefore,
selection will be based on the
availability of funds and resources for
each fiscal year. Selection will also be
based on firms having a favorable
facility status as determined by FDA’s
Office of Regulatory Affairs District
Offices in the firms’ respective regions.
Firms that want to learn more about this
training opportunity or that are
interested in offering a site tour should
respond by sending a proposed agenda
by email directly to Dan Brum (see
DATES and FOR FURTHER INFORMATION
CONTACT).
Dated: March 27, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–06327 Filed 4–1–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–P–3691]
Determination That CHLOR–
TRIMETON ALLERGY 12 HOUR
(Chlorpheniramine Maleate) Extended
Release Tablets, 8 Milligrams and 12
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 CHLOR–TRIMETON
ALLERGY 12 HOUR (chlorpheniramine
maleate) extended release tablets, 8
milligrams (mg) and 12 mg, were not
withdrawn from sale for reasons of
safety or effectiveness. This
determination means that FDA will not
begin procedures to withdraw approval
of abbreviated new drug applications
(ANDAs) that refer to this drug product,
and it will allow FDA to continue to
approve ANDAs that refer to the
product as long as they meet relevant
legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT:
Katelyn Mineo, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6213,
Silver Spring, MD 20993–0002, 301–
796–1054.
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
SUMMARY:
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Fmt 4703
Sfmt 4703
12625
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 (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
CHLOR–TRIMETON ALLERGY 12
HOUR (chlorpheniramine maleate)
extended release tablets, 8 mg and 12
mg, are the subject of NDA 007638, held
by Bayer HealthCare LLC (Bayer) and
initially approved on August 15, 1950.
CHLOR–TRIMETON ALLERGY 12
HOUR is indicated for temporary relief
of the following symptoms due to hay
fever or other upper respiratory
allergies: sneezing; runny nose; itchy,
watery eyes; itching of the nose or
throat.
In the 2005 NDA 007638 Annual
Report received on October 14, 2005,
Bayer notified FDA that CHLOR–
TRIMETON ALLERGY 12 HOUR
(chlorpheniramine maleate) extended
release tablets, 8 mg, were being
discontinued, and FDA moved the drug
product to the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book. In a letter dated February 8, 2018,
Bayer notified FDA that CHLOR–
TRIMETON ALLERGY 12 HOUR
(chlorpheniramine maleate) extended
E:\FR\FM\02APN1.SGM
02APN1
]]>Agencies
[Federal Register Volume 84, Number 63 (Tuesday, April 2, 2019)]
[Notices]
[Pages 12624-12625]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06327]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0179]
Training Program for Regulatory Project Managers; Information
Available to Industry
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration's (FDA or the Agency) Center
for Drug Evaluation and Research (CDER) is announcing the continuation
of the Regulatory Project Management Site Tours and Regulatory
Interaction Program (the Site Tours Program). The purpose of this
document is to invite pharmaceutical companies interested in
participating in this program to contact CDER.
DATES: Pharmaceutical companies may send proposed agendas to the Agency
by June 3, 2019.
FOR FURTHER INFORMATION CONTACT: Dan Brum, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 5480, Silver Spring, MD 20993-0002, 301-796-0578,
[email protected].
[[Page 12625]]
SUPPLEMENTARY INFORMATION:
I. Background
An important part of CDER's commitment to make safe and effective
drugs available to all Americans is optimizing the efficiency and
quality of the drug review process. To support this goal, CDER has
initiated various training and development programs to promote high
performance in its regulatory project management staff. CDER seeks to
enhance review efficiency and review quality by providing the staff
with a better understanding of the pharmaceutical industry and its
operations. To this end, CDER is continuing its training program to
give regulatory project managers the opportunity to tour pharmaceutical
facilities. The goals are to provide the following: (1) Firsthand
exposure to industry's drug development processes and (2) a venue for
sharing information about project management procedures (but not drug-
specific information) with industry representatives.
II. The Site Tours Program
In this program, over a 2- to 3-day period, small groups (five or
less) of CDER regulatory project managers, including a senior level
regulatory project manager, can observe operations of pharmaceutical
manufacturing and/or packaging facilities, pathology/toxicology
laboratories, and regulatory affairs operations. Neither this tour nor
any part of the program is intended as a mechanism to inspect, assess,
judge, or perform a regulatory function, but is meant rather to improve
mutual understanding and to provide an avenue for open dialogue. During
the Site Tours Program, regulatory project managers will also
participate in daily workshops with their industry counterparts,
focusing on selective regulatory issues important to both CDER staff
and industry. The primary objective of the daily workshops is to learn
about the team approach to drug development, including drug discovery,
preclinical evaluation, tracking mechanisms, and regulatory submission
operations. The overall benefit to regulatory project managers will be
exposure to project management, team techniques, and processes employed
by the pharmaceutical industry. By participating in this program, the
regulatory project manager will grow professionally by gaining a better
understanding of industry processes and procedures.
III. Site Selection
All travel expenses associated with the Site Tours Program will be
the responsibility of CDER; therefore, selection will be based on the
availability of funds and resources for each fiscal year. Selection
will also be based on firms having a favorable facility status as
determined by FDA's Office of Regulatory Affairs District Offices in
the firms' respective regions. Firms that want to learn more about this
training opportunity or that are interested in offering a site tour
should respond by sending a proposed agenda by email directly to Dan
Brum (see DATES and FOR FURTHER INFORMATION CONTACT).
Dated: March 27, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-06327 Filed 4-1-19; 8:45 am]
BILLING CODE 4164-01-P
