Science Board to the Food and Drug Administration; Amendment of Notice, 3831 [2014-01298]
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Federal Register / Vol. 79, No. 15 / Thursday, January 23, 2014 / Notices
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area). Please call
the Information Line for up-to-date
information on this meeting.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to the advisory committees.
Dated: January 17, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
Dated: January 17, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–01312 Filed 1–22–14; 8:45 am]
[FR Doc. 2014–01298 Filed 1–22–14; 8:45 am]
BILLING CODE 4160–01–P
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
[Docket No. FDA–2012–E–0456]
Science Board to the Food and Drug
Administration; Amendment of Notice
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
AGENCY:
Notice.
The Food and Drug
Administration (FDA) is announcing an
amendment to the notice of meeting of
the Science Board to the Food and Drug
Administration. This meeting was
announced in the Federal Register of
January 9, 2014 (79 FR 1645). The
amendment is being made to reflect a
change in the Date and Time and the
Agenda portions of the document. There
are no other changes.
FOR FURTHER INFORMATION CONTACT:
Martha Monser, Office of the Chief
Scientist, Office of the Commissioner,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 32, Rm.
4286, Silver Spring, MD 20993, 301–
796–4627, martha.monser@fda.hhs.gov,
or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area). Please call the information line for
up-to-date information on this meeting.
SUPPLEMENTARY INFORMATION: In the
Federal Register of January 9, 2014,
FDA announced that a meeting of the
Science Board to the Food and Drug
Administration would be held on
February 5, 2014.
1. On page 1645, in the second
column, the Date and Time portion of
the document is changed to read as
follows:
Date and time: The meeting will be
held on February 5, 2014, from
approximately 8:30 a.m. until 1 p.m.
2. On page 1645, in the second
column, under Agenda, in the first
paragraph, after the third sentence, the
following sentence is added to read as
follows:
The Office of Women’s Health (OWH)
will seek input from the Board on the
development of the OWH Research
Roadmap.
sroberts on DSK5SPTVN1PROD with NOTICES
21:50 Jan 22, 2014
Food and Drug Administration,
HHS.
SUMMARY:
VerDate Mar<15>2010
Determination of Regulatory Review
Period for Purposes of Patent
Extension; DALIRESP
Jkt 232001
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
DALIRESP and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of an
application to the Director of Patents
and Trademarks, Department of
Commerce, for the extension of a patent
which claims that human drug product.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
petitions (two copies are necessary) and
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA 2013–S–0610.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of
Management, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6284, Silver Spring,
MD 20993–0002, 301–796–7900.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
and the Generic Animal Drug and Patent
Term Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
SUMMARY:
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
3831
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of Patents and Trademarks may
award (for example, half the testing
phase must be subtracted as well as any
time that may have occurred before the
patent was issued), FDA’s determination
of the length of a regulatory review
period for a human drug product will
include all of the testing phase and
approval phase as specified in 35 U.S.C.
156(g)(1)(B).
FDA recently approved for marketing
the human drug product DALIRESP
(roflumilast). DALIRESP is indicated as
a treatment to reduce the risk of chronic
obstructive pulmonary disease (COPD)
exacerbations in patients with severe
COPD associated with chronic
bronchitis and a history of
exacerbations. Subsequent to this
approval, the U.S. Patent and
Trademark Office received a patent term
restoration application for DALIRESP
(U.S. Patent No. 5,712,298) from
Nycomed GmbH, and the U.S. Patent
and Trademark Office requested FDA’s
assistance in determining this patent’s
eligibility for patent term restoration. In
a letter dated August 7, 2012, FDA
advised the U.S. Patent and Trademark
Office that this human drug product had
undergone a regulatory review period
and that the approval of DALIRESP
represented the first permitted
commercial marketing or use of the
product. Thereafter, the U.S. Patent and
Trademark Office requested that FDA
determine the product’s regulatory
review period.
FDA has determined that the
applicable regulatory review period for
DALIRESP is 4,237 days. Of this time,
3,645 days occurred during the testing
phase of the regulatory review period,
while 592 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 355(i)) became effective: July 26,
1999. The applicant claims December
19, 1999, as the date the investigational
E:\FR\FM\23JAN1.SGM
23JAN1
]]>Agencies
[Federal Register Volume 79, Number 15 (Thursday, January 23, 2014)]
[Notices]
[Page 3831]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-01298]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0001]
Science Board to the Food and Drug Administration; Amendment of
Notice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
amendment to the notice of meeting of the Science Board to the Food and
Drug Administration. This meeting was announced in the Federal Register
of January 9, 2014 (79 FR 1645). The amendment is being made to reflect
a change in the Date and Time and the Agenda portions of the document.
There are no other changes.
FOR FURTHER INFORMATION CONTACT: Martha Monser, Office of the Chief
Scientist, Office of the Commissioner, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32, Rm. 4286, Silver Spring, MD 20993,
301-796-4627, martha.monser@fda.hhs.gov, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area). Please call the information line for up-to-date information on
this meeting.
SUPPLEMENTARY INFORMATION: In the Federal Register of January 9, 2014,
FDA announced that a meeting of the Science Board to the Food and Drug
Administration would be held on February 5, 2014.
1. On page 1645, in the second column, the Date and Time portion of
the document is changed to read as follows:
Date and time: The meeting will be held on February 5, 2014, from
approximately 8:30 a.m. until 1 p.m.
2. On page 1645, in the second column, under Agenda, in the first
paragraph, after the third sentence, the following sentence is added to
read as follows:
The Office of Women's Health (OWH) will seek input from the Board
on the development of the OWH Research Roadmap.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.
Dated: January 17, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-01298 Filed 1-22-14; 8:45 am]
BILLING CODE 4160-01-P
