83 FR 5429 - Determination of Regulatory Review Period for Purposes of Patent Extension; SEDASYS SYSTEM

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 26 (February 7, 2018)

Page Range		5429-5431
FR Document		2018-02432

The Food and Drug Administration (FDA or Agency) has determined the regulatory review period for SEDASYS SYSTEM 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 the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.

Federal Register, Volume 83 Issue 26 (Wednesday, February 7, 2018)

[Federal Register Volume 83, Number 26 (Wednesday, February 7, 2018)]
[Notices]
[Pages 5429-5431]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-02432]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-E-1240]

Determination of Regulatory Review Period for Purposes of Patent
Extension; SEDASYS SYSTEM

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined the regulatory review period for SEDASYS SYSTEM 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 the U.S. Patent and Trademark Office (USPTO),
Department of Commerce, for the extension of a patent which claims that
medical device.

DATES: Anyone with knowledge that any of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by April
9, 2018. 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 August 6, 2018.
See ``Petitions'' in the

[[Page 5430]]

SUPPLEMENTARY INFORMATION section for more information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 9, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 9, 2018. Comments received by
mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets 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-2014-E-1240 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; SEDASYS SYSTEM.'' 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.'' The Agency 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 Sec. 10.20 (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.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.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 and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.

SUPPLEMENTARY INFORMATION:

I. Background

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 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 medical devices, the testing
phase begins with a clinical investigation of the device and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the device and continues until
permission to market the device is granted. Although only a portion of
a regulatory review period may count toward the actual amount of
extension that the Director of USPTO may award (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 medical device will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(3)(B).
FDA has approved for marketing the medical device SEDASYS SYSTEM.
SEDASYS SYSTEM is indicated for intravenous administration of 1 percent
propofol injectable emulsion for the initiation and maintenance of
minimal to moderate sedation, as defined by the American Society of
Anesthesiologists (ASA) Continuum of Depth of Sedation in ASA physical
status I and II patients. Subsequent to this approval, the USPTO
received a patent term restoration application for SEDASYS SYSTEM (U.S.
Patent No. 6,807,965) from Scott Laboratories, Inc., and the USPTO
requested FDA's assistance in determining this patent's eligibility for
patent term restoration. In a letter dated November 3, 2015, FDA
advised the USPTO that this medical device had undergone a regulatory
review period and that the approval of SEDASYS SYSTEM represented the
first permitted commercial marketing or use of the product. Thereafter,
the USPTO requested that FDA determine the product's regulatory review
period.

[[Page 5431]]

II. Determination of Regulatory Review Period

FDA has determined that the applicable regulatory review period for
SEDASYS SYSTEM is 2,816 days. Of this time, 950 days occurred during
the testing phase of the regulatory review period, while 1,866 days
occurred during the approval phase. These periods of time were derived
from the following dates:
1. The date an exemption under section 520(g) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(g)) involving
this device became effective: August 19, 2005. The applicant claims
that the investigational device exemption (IDE) required under section
520(g) of the FD&C Act for human tests to begin became effective on
November 30, 2005. However, FDA records indicate that the IDE was
determined substantially complete for clinical studies to have begun on
August 19, 2005, which represents the IDE effective date.
2. The date an application was initially submitted with respect to
the device under section 515 of the FD&C Act (21 U.S.C. 360e): March
25, 2008. FDA has verified the applicant's claim that the premarket
approval application (PMA) for SEDASYS SYSTEM (PMA P080009) was
initially submitted March 25, 2008.
3. The date the application was approved: May 3, 2013. FDA has
verified the applicant's claim that PMA P080009 was approved on May 3,
2013.
This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 2,283 days of patent term extension.

III. Petitions

Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec. 60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec. 60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec. 10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (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.
Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Dated: January 31, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02432 Filed 2-6-18; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 26 / Wednesday, February 7, 2018 / Notices 5429

In the Federal Register of November comment on the proposed extension of estimate the burden of the information
8, 2017 (82 FR 51846), we published a this collection of information. No collection as follows:
60-day notice requesting public comments were received. We therefore

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Guidance for industry: Expedited Total Average
Number of responses
programs for serious conditions— annual burden per Total hours
respondents per
Drugs and biologics responses response
respondent

Priority review designation request (0765) .......................... 48 1.7 82 30 2,400
Breakthrough therapy designation request (0765) .............. 87 1.29 113 70 7,910
Fast track designation request (0389) ................................. 140 1.33 187 60 11,220
Fast track premeeting packages (0389) .............................. 107 1.23 132 100 13,200

Total .............................................................................. ........................ ........................ ........................ ........................ 34,730
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The information collection elements information and discussion in a designation and fast track meetings has
regarding priority review designation designation request need not be increased due to increased requests;
and breakthrough therapy designation voluminous, but it should be sufficient however, the hours per request have
requests are reflected in rows 1 and 2 of to permit a reviewer to assess whether remained the same.
table 1 and are currently approved the criteria for fast track designation Dated: February 1, 2018.
under OMB control number 0910–0765. have been met. Leslie Kux,
Meanwhile, fast track designation After the Agency makes a fast track
Associate Commissioner for Policy.
requests and premeeting packages are designation, a sponsor or applicant may
[FR Doc. 2018–02415 Filed 2–6–18; 8:45 am]
currently approved under OMB Control submit a premeeting package that may
include additional information BILLING CODE 4164–01–P
No. 0910–0389. We are therefore
revising OMB control number 0910– supporting a request to participate in
0389 to include all four collection certain fast track programs. The
DEPARTMENT OF HEALTH AND
elements. Information collection burden premeeting package serves as
HUMAN SERVICES
for accelerated approval requests is background information for the meeting
currently approved under OMB control and should support the intended Food and Drug Administration
numbers 0910–0001 (drugs) and 0910– objectives of the meeting. As with the
0338 (biologics). The estimates provided request for fast track designation, the [Docket No. FDA–2014–E–1240]
are based on our experience with the Agency expects that most sponsors or
respective collection elements over the Determination of Regulatory Review
applicants will have gathered such
past 3 years. Period for Purposes of Patent
information to meet existing
A sponsor or applicant who seeks fast Extension; SEDASYS SYSTEM
requirements for preparing an IND,
track designation is required to submit NDA, or BLA. These may include AGENCY: Food and Drug Administration,
a request to the Agency showing that the descriptions of clinical safety and HHS.
drug product: (1) Is intended for a efficacy trials not conducted under an ACTION: Notice.
serious or life-threatening condition, IND (e.g., foreign studies) and
and (2) has the potential to address an information to support a request for SUMMARY: The Food and Drug
unmet medical need. The Agency accelerated approval. If such Administration (FDA or Agency) has
expects that most information to information has already been submitted determined the regulatory review period
support a designation request will have to FDA, the information may be for SEDASYS SYSTEM and is
been gathered under existing summarized in the premeeting package. publishing this notice of that
requirements for preparing an The Agency estimates the total annual determination as required by law. FDA
investigational new drug (IND), new number of respondents submitting has made the determination because of
drug application (NDA), or biologics requests for fast track designation is the submission of an application to the
license application (BLA). If such approximately 140, and the number of Director of the U.S. Patent and
information has already been submitted requests received is approximately 187 Trademark Office (USPTO), Department
to the Agency, the information may be annually. FDA estimates that the of Commerce, for the extension of a
summarized in the fast track designation number of hours needed to prepare a patent which claims that medical
request. A designation request should request for fast track designation is device.
include, where applicable, additional approximately 60 hours per request DATES: Anyone with knowledge that any
information not specified elsewhere by (row 3 in table 1). of the dates as published (in the
statute or regulation. For example, Of the requests for fast track SUPPLEMENTARY INFORMATION section) are
additional information may be needed designation made per year, the Agency incorrect may submit either electronic
to show that a product has the potential granted approximately 132 requests
sradovich on DSK3GMQ082PROD with NOTICES

or written comments and ask for a
to address an unmet medical need from 107 respondents, and for each of redetermination by April 9, 2018.
where an approved therapy exists for these granted requests, a premeeting Furthermore, any interested person may
the serious or life-threatening condition package was submitted to the Agency. petition FDA for a determination
to be treated. Such information may FDA estimates that the preparation regarding whether the applicant for
include clinical data, published reports, hours are approximately 100 hours per extension acted with due diligence
summaries of data and reports, and a list premeeting package (row 4 in table 1). during the regulatory review period by
of references. The amount of The total burden hours for fast track August 6, 2018. See ‘‘Petitions’’ in the

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Document Created: 2018-10-26 13:57:41
Document Modified: 2018-10-26 13:57:41

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Anyone with knowledge that any of the dates as published (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by April 9, 2018. 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 August 6, 2018. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information.
Contact		Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
FR Citation		83 FR 5429

83 FR 5429 - Determination of Regulatory Review Period for Purposes of Patent Extension; SEDASYS SYSTEM

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 26 (February 7, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration