82 FR 27496 - Determination of Regulatory Review Period for Purposes of Patent Extension; NATPARA

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 114 (June 15, 2017)

Page Range		27496-27497
FR Document		2017-12359

The Food and Drug Administration (FDA) has determined the regulatory review period for NATPARA 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 human biological product.

Federal Register, Volume 82 Issue 114 (Thursday, June 15, 2017)

[Federal Register Volume 82, Number 114 (Thursday, June 15, 2017)]
[Notices]
[Pages 27496-27497]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2017-12359]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-E-0118]

Determination of Regulatory Review Period for Purposes of Patent
Extension; NATPARA

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for NATPARA 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 human biological product.

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by August
14, 2017. 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 December 12, 2017.
See ``Petitions'' in the 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 August 14, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of August 14, 2017. 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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2016-E-0118 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; NATPARA.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Division of Dockets Management 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 Division of Dockets Management. 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.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 Division of Dockets Management, 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 human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological product becomes effective and runs
until the approval phase

[[Page 27497]]

begins. The approval phase starts with the initial submission of an
application to market the human biological product and continues until
FDA grants permission to market the biological product. Although only a
portion of a regulatory review period may count toward the actual
amount of extension that the Director of USPTO 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 biological product
will include all of the testing phase and approval phase as specified
in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human biologic product NATPARA
(parathyroid hormone (recombinant human)). NATPARA is indicated as an
adjunct to calcium and vitamin D to control hypocalcemia in patients
with hypoparathyroidism. Subsequent to this approval, the USPTO
received a patent term restoration application for NATPARA (U.S. Patent
No. 5,496,801) from NPS Pharmaceuticals Inc., and the USPTO requested
FDA's assistance in determining this patent's eligibility for patent
term restoration. In a letter dated March 10, 2016, FDA advised the
USPTO that this human biological product had undergone a regulatory
review period and that the approval of NATPARA represented the first
permitted commercial marketing or use of the product. Thereafter, the
USPTO requested that FDA determine the product's regulatory review
period.

II. Determination of Regulatory Review Period

FDA has determined that the applicable regulatory review period for
NATPARA is 7,268 days. Of this time, 6,811 days occurred during the
testing phase of the regulatory review period, while 457 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 (21 U.S.C. 355(i)) became effective: March 3,
1995. The applicant claims January 31, 1995, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was March 3, 1995,
which was 30 days after FDA receipt of the IND.
2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): October 24, 2013. FDA has verified the
applicant's claim that the biologics license application (BLA) for
NATPARA (BLA 125511) was initially submitted on October 24, 2013.
3. The date the application was approved: January 23, 2015. FDA has
verified the applicant's claim that BLA 125511 was approved on January
23, 2015.
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 5 years 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 ask for
a redetermination (see DATES). 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.
To meet its burden, the petition must be timely (see ADDRESSES) and
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.
Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Dated: June 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12359 Filed 6-14-17; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 114 / Thursday, June 15, 2017 / Notices 27497

begins. The approval phase starts with biologics license application (BLA) for in participating in the selection of
the initial submission of an application NATPARA (BLA 125511) was initially voting and/or nonvoting consumer
to market the human biological product submitted on October 24, 2013. representatives to serve on its advisory
and continues until FDA grants 3. The date the application was committees or panels notify FDA in
permission to market the biological approved: January 23, 2015. FDA has writing. FDA is also requesting
product. Although only a portion of a verified the applicant’s claim that BLA nominations for voting and/or
regulatory review period may count 125511 was approved on January 23, nonvoting consumer representatives to
toward the actual amount of extension 2015. serve on advisory committees and/or
that the Director of USPTO may award This determination of the regulatory panels for which vacancies currently
(for example, half the testing phase must review period establishes the maximum exist or are expected to occur in the near
be subtracted as well as any time that potential length of a patent extension. future. Nominees recommended to serve
may have occurred before the patent However, the USPTO applies several as a voting or nonvoting consumer
was issued), FDA’s determination of the statutory limitations in its calculations representative may be self-nominated or
length of a regulatory review period for of the actual period for patent extension. may be nominated by a consumer
a human biological product will include In its application for patent extension, organization.
all of the testing phase and approval this applicant seeks 5 years of patent FDA seeks to include the views of
phase as specified in 35 U.S.C. term extension. women and men, members of all racial
156(g)(1)(B). and ethnic groups, and individuals with
FDA has approved for marketing the III. Petitions and without disabilities on its advisory
human biologic product NATPARA Anyone with knowledge that any of committees and, therefore, encourages
(parathyroid hormone (recombinant the dates as published are incorrect may nominations of appropriately qualified
human)). NATPARA is indicated as an submit either electronic or written candidates from these groups.
adjunct to calcium and vitamin D to comments and ask for a redetermination DATES: Any consumer organization
control hypocalcemia in patients with (see DATES). Furthermore, any interested interested in participating in the
hypoparathyroidism. Subsequent to this person may petition FDA for a selection of an appropriate voting or
approval, the USPTO received a patent determination regarding whether the nonvoting member to represent
term restoration application for applicant for extension acted with due consumer interests on an FDA advisory
NATPARA (U.S. Patent No. 5,496,801) diligence during the regulatory review committee or panel may send a letter or
from NPS Pharmaceuticals Inc., and the period. To meet its burden, the petition email stating that interest to FDA (see
USPTO requested FDA’s assistance in must be timely (see ADDRESSES) and ADDRESSES) by July 17, 2017, for
determining this patent’s eligibility for contain sufficient facts to merit an FDA vacancies listed in this notice.
patent term restoration. In a letter dated investigation. (See H. Rept. 857, part 1, Concurrently, nomination materials for
March 10, 2016, FDA advised the 98th Cong., 2d sess., pp. 41–42, 1984.) prospective candidates should be sent to
USPTO that this human biological Petitions should be in the format FDA (see ADDRESSES) by July 17, 2017.
product had undergone a regulatory specified in 21 CFR 10.30. Nominations will be accepted for
review period and that the approval of Submit petitions electronically to current vacancies and for those that will
NATPARA represented the first https://www.regulations.gov at Docket or may occur through November 30,
permitted commercial marketing or use No. FDA–2013–S–0610. Submit written 2017.
of the product. Thereafter, the USPTO petitions (two copies are required) to the
ADDRESSES: All statements of interest
requested that FDA determine the Division of Dockets Management (HFA–
product’s regulatory review period. 305), Food and Drug Administration, from consumer organizations interested
5630 Fishers Lane, Rm. 1061, Rockville, in participating in the selection process
II. Determination of Regulatory Review and consumer representative
MD 20852.
Period nominations should be submitted
Dated: June 9, 2017. electronically to ACOMSSubmissions@
FDA has determined that the
Anna K. Abram, fda.hhs.gov, by mail to Advisory
applicable regulatory review period for
NATPARA is 7,268 days. Of this time, Deputy Commissioner for Policy, Planning, Committee Oversight and Management
Legislation, and Analysis. Staff, 10903 New Hampshire Ave., Bldg.
6,811 days occurred during the testing
[FR Doc. 2017–12359 Filed 6–14–17; 8:45 am] 32, Rm. 5103, Silver Spring, MD 20993–
phase of the regulatory review period,
while 457 days occurred during the BILLING CODE 4164–01–P 0002, or by FAX: 301–847–8640.
approval phase. These periods of time Consumer representative nominations
were derived from the following dates: should be submitted electronically by
1. The date an exemption under DEPARTMENT OF HEALTH AND logging into the FDA Advisory
section 505(i) of the Federal Food, Drug, HUMAN SERVICES Committee Membership Nomination
and Cosmetic Act (21 U.S.C. 355(i)) Portal at: https://
Food and Drug Administration www.accessdata.fda.gov/scripts/
became effective: March 3, 1995. The
applicant claims January 31, 1995, as [Docket No. FDA–2017–N–0001] FACTRSPortal/FACTRS/index.cfm, by
the date the investigational new drug mail to Advisory Committee Oversight
application (IND) became effective. Request for Nominations for and Management Staff, 10903 New
However, FDA records indicate that the Individuals and Consumer Hampshire Ave., Bldg. 32, Rm. 5103,
IND effective date was March 3, 1995, Organizations for Advisory Silver Spring, MD 20993–0002, or by
Committees
pmangrum on DSK3GDR082PROD with NOTICES

which was 30 days after FDA receipt of FAX: 301–847–8640. Additional
the IND. AGENCY: Food and Drug Administration, information about becoming a member
2. The date the application was HHS. on an FDA advisory committee can also
initially submitted with respect to the be obtained by visiting FDA’s Web site
ACTION: Notice.
human biological product under section at http://www.fda.gov/
351 of the Public Health Service Act (42 SUMMARY: The Food and Drug AdvisoryCommittees/default.htm.
U.S.C. 262): October 24, 2013. FDA has Administration (FDA) is requesting that FOR FURTHER INFORMATION CONTACT: For
verified the applicant’s claim that the any consumer organizations interested questions relating to participation in the

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Document Created: 2017-06-15 01:03:49
Document Modified: 2017-06-15 01:03:49

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 (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by August 14, 2017. 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 December 12, 2017. 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		82 FR 27496

82 FR 27496 - Determination of Regulatory Review Period for Purposes of Patent Extension; NATPARA

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 114 (June 15, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration