Determination of Regulatory Review Period for Purposes of Patent Extension; ENTEREG; U.S. Patent Nos. 5,250,542 and 5,434,171, 52241-52242 [E9-24457]
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52241
Federal Register / Vol. 74, No. 195 / Friday, October 9, 2009 / Notices
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN—Continued
Number of
respondents
Form name
Total burden
hours
Average hourly wage rate*
Total cost
burden
Institutions (non-hospital) questionnaire ..........................................................
Pharmacies questionnaire ...............................................................................
72
7,760
9
9,040
14.24
14.24
128
128,730
Subtotal for the MEPS–MPC ....................................................................
39,813
20,077
na
285,965
Grand Total .......................................................................................
92,613
82,767
na
1,512,181
*Based upon the mean of the average
wages for Healthcare Support Workers, All
Other (31–9099) and All Occupations (00–
0000), Occupational Employment Statistics,
May 2007 National Occupational
Employment and Wage Estimates United
States, U.S. Department of Labor, Bureau of
Labor Statistics. https://www.bls.gov/oes/
current/oes_nat.htm#b29–0000.
Estimated Annual Costs to the Federal
Government
Exhibit 3 shows the total and
annualized cost of this information
collection. The cost associated with the
design and data collection of the MEPS–
HC and MEPS–MPC is estimated to be
$47.6 million in each of the next three
fiscal years.
EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST
Total cost
(millions)
Cost Component
Annualized
cost
(millions)
Sampling Activities ...................................................................................................................................................
Interviewer Recruitment and Training .....................................................................................................................
Data Collection Activities .........................................................................................................................................
Data Processing ......................................................................................................................................................
Production of Public Use Data Files .......................................................................................................................
Project Management ................................................................................................................................................
$2.79
8.52
86.7
21.39
19.53
3.93
$0.93
2.84
28.9
7.13
6.51
1.31
Total ..................................................................................................................................................................
142.8
47.6
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Request for Comments
In accordance with the above-cited
Paperwork Reduction Act legislation,
comments on AHRQ’s information
collection are requested with regard to
any of the following: (a) Whether the
proposed collection of information is
necessary for the proper performance of
AHRQ health care research and health
care information dissemination
functions, including whether the
information will have practical utility;
(b) the accuracy of AHRQ’s estimate of
burden (including hours and costs) of
the proposed collection(s) of
information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for 0MB approval of the
proposed information collection. All
comments will become a matter of
public record.
VerDate Nov<24>2008
16:05 Oct 08, 2009
Jkt 220001
Dated: September 16, 2009.
Carol M. Clancy,
Director.
[FR Doc. E9–24305 Filed 10–8–09; 8:45 am]
BILLING CODE 4160–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2009–E–0073 and FDA–
2009–E–0015]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; ENTEREG; U.S. Patent Nos.
5,250,542 and 5,434,171
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
ENTEREG and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of
applications to the Director of Patents
and Trademarks, Department of
Commerce, for the extension of patents
which claim that human drug product.
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ADDRESSES: Submit written comments
and petitions to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
rm. 6222, Silver Spring, MD 20993–
0002, 301–796–3602.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) and the Generic Animal Drug and
Patent Term Restoration Act (Public
Law 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 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
E:\FR\FM\09OCN1.SGM
09OCN1
mstockstill on DSKH9S0YB1PROD with NOTICES
52242
Federal Register / Vol. 74, No. 195 / Friday, October 9, 2009 / Notices
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 ENTEREG
(alvimopan). ENTEREG is a peripherally
acting μ-opioid receptor antagonist
indicated to accelerate the time to upper
and lower gastrointestinal recovery
following partial large or small bowel
resection surgery with primary
anastomosis. Subsequent to this
approval, the Patent and Trademark
Office received patent term restoration
applications for ENTEREG (U.S. Patent
Nos. 5,250,542 and 5,434,171) from Eli
Lilly and Company, and the Patent and
Trademark Office requested FDA’s
assistance in determining this patent’s
eligibility for patent term restoration. In
a letter dated February 26, 2009, FDA
advised the Patent and Trademark
Office that this human drug product had
undergone a regulatory review period
and that the approval of ENTEREG
represented the first permitted
commercial marketing or use of the
product. Thereafter, the Patent and
Trademark Office requested that FDA
determine the product’s regulatory
review period.
FDA has determined that the
applicable regulatory review period for
ENTEREG is 5,305 days. Of this time,
3,879 days occurred during the testing
phase of the regulatory review period,
while 1,426 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 act) (21 U.S.C.
355(i)) became effective: November 12,
1993. The applicant claims November
11, 1993, as the date the investigational
new drug application (IND) became
effective. However, FDA records
indicate that the IND effective date was
November 12, 1993, which was 30 days
after FDA receipt of the IND.
VerDate Nov<24>2008
16:05 Oct 08, 2009
Jkt 220001
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the act: June 25, 2004. FDA
has verified the applicant’s claim that
the new drug application (NDA) 21–775
was submitted on June 25, 2004.
3. The date the application was
approved: May 20, 2008. FDA has
verified the applicant’s claim that NDA
21–775 was approved on May 20, 2008.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the U.S. Patent and
Trademark Office applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its applications for patent extension,
this applicant seeks 1,827 days of patent
term extension for U.S. Patent No.
5,250,542 and 1,826 days of patent term
extension for U.S. Patent No. 5,434,171.
Anyone with knowledge that any of
the dates as published are incorrect may
submit to the Division of Dockets
Management (see ADDRESSES) written or
electronic comments and ask for a
redetermination by December 8, 2009.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
April 7, 2010. To meet its burden, the
petition must contain sufficient facts to
merit an FDA investigation. (See H.
Rept. 857, part 1, 98th Cong., 2d sess.,
pp. 41–42, 1984.) Petitions should be in
the format specified in 21 CFR 10.30.
Comments and petitions should be
submitted to the Division of Dockets
Management. Three copies of any
mailed information are to be submitted,
except that individuals may submit one
copy. Comments are to be identified
with the docket number found in
brackets in the heading of this
document. Comments and petitions may
be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: August 31, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E9–24457 Filed 10–8–09; 8:45 am]
BILLING CODE 4160–01–S
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Fmt 4703
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0448]
Draft Guidance for Industry and Food
and Drug Administration Staff; the
Mammography Quality Standards Act
Final Regulations: Modifications and
Additions to Policy Guidance Help
System #13; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘The Mammography Quality
Standards Act Final Regulations:
Modifications and Additions to Policy
Guidance Help System #13.’’ This
document is intended to provide
guidance to mammography facilities
and their personnel. It represents FDA’s
current thinking on the final regulations
implementing the Mammography
Quality Standards Act of 1992 (MQSA).
This guidance document updates
previous guidance. This draft guidance
is not final nor is it in effect at this time.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by January 7, 2010.
ADDRESSES: Submit written requests for
single copies of the draft guidance
document entitled ‘‘The Mammography
Quality Standards Act Final
Regulations: Modifications and
Additions to Policy Guidance Help
System #13’’ to the Division of Small
Manufacturers, International, and
Consumer Assistance, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 4613,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
request, or fax your request to 301–847–
8149. See the SUPPLEMENTARY
INFORMATION section for information on
electronic access to the guidance.
Submit written comments concerning
this draft guidance to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to https://
www.regulations.gov. Identify
comments with the docket number
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09OCN1
Agencies
[Federal Register Volume 74, Number 195 (Friday, October 9, 2009)]
[Notices]
[Pages 52241-52242]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-24457]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2009-E-0073 and FDA-2009-E-0015]
Determination of Regulatory Review Period for Purposes of Patent
Extension; ENTEREG; U.S. Patent Nos. 5,250,542 and 5,434,171
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for ENTEREG and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of applications to the Director of Patents
and Trademarks, Department of Commerce, for the extension of patents
which claim that human drug product.
ADDRESSES: Submit written comments and petitions to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of
Regulatory Policy, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 51, rm. 6222, Silver Spring, MD 20993-0002, 301-796-3602.
SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Public Law 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 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
[[Page 52242]]
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 ENTEREG
(alvimopan). ENTEREG is a peripherally acting micro-opioid receptor
antagonist indicated to accelerate the time to upper and lower
gastrointestinal recovery following partial large or small bowel
resection surgery with primary anastomosis. Subsequent to this
approval, the Patent and Trademark Office received patent term
restoration applications for ENTEREG (U.S. Patent Nos. 5,250,542 and
5,434,171) from Eli Lilly and Company, and the Patent and Trademark
Office requested FDA's assistance in determining this patent's
eligibility for patent term restoration. In a letter dated February 26,
2009, FDA advised the Patent and Trademark Office that this human drug
product had undergone a regulatory review period and that the approval
of ENTEREG represented the first permitted commercial marketing or use
of the product. Thereafter, the Patent and Trademark Office requested
that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for
ENTEREG is 5,305 days. Of this time, 3,879 days occurred during the
testing phase of the regulatory review period, while 1,426 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 act) (21 U.S.C. 355(i)) became effective:
November 12, 1993. The applicant claims November 11, 1993, as the date
the investigational new drug application (IND) became effective.
However, FDA records indicate that the IND effective date was November
12, 1993, which was 30 days after FDA receipt of the IND.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the act: June 25, 2004.
FDA has verified the applicant's claim that the new drug application
(NDA) 21-775 was submitted on June 25, 2004.
3. The date the application was approved: May 20, 2008. FDA has
verified the applicant's claim that NDA 21-775 was approved on May 20,
2008.
This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
applications for patent extension, this applicant seeks 1,827 days of
patent term extension for U.S. Patent No. 5,250,542 and 1,826 days of
patent term extension for U.S. Patent No. 5,434,171.
Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) written or electronic comments and ask for a redetermination
by December 8, 2009. Furthermore, any interested person may petition
FDA for a determination regarding whether the applicant for extension
acted with due diligence during the regulatory review period by April
7, 2010. To meet its burden, the petition must contain sufficient facts
to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong.,
2d sess., pp. 41-42, 1984.) Petitions should be in the format specified
in 21 CFR 10.30.
Comments and petitions should be submitted to the Division of
Dockets Management. Three copies of any mailed information are to be
submitted, except that individuals may submit one copy. Comments are to
be identified with the docket number found in brackets in the heading
of this document. Comments and petitions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: August 31, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E9-24457 Filed 10-8-09; 8:45 am]
BILLING CODE 4160-01-S