80 FR 21247 - Determination of Regulatory Review Period for Purposes of Patent Extension; RAVICTI

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 74 (April 17, 2015)

Page Range		21247-21248
FR Document		2015-08845

The Food and Drug Administration (FDA) has determined the regulatory review period for RAVICTI 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 drug product.

Federal Register, Volume 80 Issue 74 (Friday, April 17, 2015)

[Federal Register Volume 80, Number 74 (Friday, April 17, 2015)]
[Notices]
[Pages 21247-21248]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-08845]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-E-0152]

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

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 RAVICTI 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 drug product.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written petitions (two copies are required) 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 http://www.regulations.gov at Docket
No. FDA-2013-S-0610.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of
Management, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Campus Rm. 3180, Silver Spring, MD 20993, 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 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 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
drug 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 drug product RAVICTI
(glycerol phenylbutyrate). RAVICTI is indicated for use as a nitrogen-
binding agent for chronic management of adult and pediatric patients 2
years of age or older with urea cycle disorders that cannot be managed
by dietary protein restriction

[[Page 21248]]

and/or amino acid supplementation alone. Subsequent to this approval,
the USPTO received a patent term restoration application for RAVICTI
(U.S. Patent No. 5,968,979) from Hyperion Therapeutics, Inc., and the
USPTO requested FDA's assistance in determining this patent's
eligibility for patent term restoration. In a letter dated May 2, 2014,
FDA advised the USPTO that this human drug product had undergone a
regulatory review period and that the approval of RAVICTI represented
the first permitted commercial marketing or use of the product.
Thereafter, the USPTO requested that FDA determine the product's
regulatory review period.
FDA has determined that the applicable regulatory review period for
RAVICTI is 2,126 days. Of this time, 1,719 days occurred during the
testing phase of the regulatory review period, while 407 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: April 10, 2007. The applicant claims April 8, 2006, as the
date the investigational new drug application (IND) became effective.
However, FDA records indicate that the IND effective date was April 10,
2007, when the IND was removed from clinical hold.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: December
23, 2011. FDA has verified the applicant's claim that the new drug
application (NDA) for RAVICTI (NDA 203284) was submitted on December
23, 2011.
3. The date the application was approved: February 1, 2013. FDA has
verified the applicant's claim that NDA 203284 was approved on February
1, 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 1,450 days of patent term extension.
Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by June 16, 2015. 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 October 14, 2015. 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.
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written or
electronic petitions. It is only necessary to send one set of comments.
Identify comments with the docket number found in brackets in the
heading of this document. If you submit a written petition, two copies
are required. A petition submitted electronically must be submitted to
http://www.regulations.gov, Docket No. FDA-2013-S-0610. Comments and
petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.

Dated: April 14, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-08845 Filed 4-16-15; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 74 / Friday, April 17, 2015 / Notices 21247

DEPARTMENT OF HEALTH AND OMB No.: 0970–0204 sources, and other relevant data
HUMAN SERVICES Description: On an annual basis, including the number of noncustodial
States must provide OCSE with data on parents who were able to obtain
Administration for Children and increased parenting time with their
programs that the Grants to States for
Families children.
Access and Visitation Program has
Proposed Information Collection funded. These program reporting Respondents: State Child Access and
Activity; Comment Request requirements include, but are not Visitation Programs and State and/or
limited to, the collection of data on the local service providers.
Proposed Projects number of parents served, types of
Title: Grants to States for Access and services delivered, program outcomes,
Visitation client socio economic data, referrals

ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response

Online Portal Survey by States and Jurisdictions ........................................... 54 1 16 864
Survey of local service grantees ..................................................................... 331 1 16 5,296

Estimated Total Annual Burden DEPARTMENT OF HEALTH AND Restoration Act of 1984 (Pub. L. 98–417)
Hours: 6,160. HUMAN SERVICES and the Generic Animal Drug and Patent
In compliance with the requirements Term Restoration Act (Pub. L. 100–670)
Food and Drug Administration generally provide that a patent may be
of section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the [Docket No. FDA–2014–E–0152] extended for a period of up to 5 years
Administration for Children and so long as the patented item (human
Families is soliciting public comment Determination of Regulatory Review drug product, animal drug product,
on the specific aspects of the Period for Purposes of Patent medical device, food additive, or color
Extension; RAVICTI additive) was subject to regulatory
information collection described above.
review by FDA before the item was
Copies of the proposed collection of AGENCY: Food and Drug Administration, marketed. Under these acts, a product’s
information can be obtained and HHS. regulatory review period forms the basis
comments may be forwarded by writing ACTION: Notice. for determining the amount of extension
to the Administration for Children and
an applicant may receive.
Families, Office of Planning, Research SUMMARY: The Food and Drug
and Evaluation, 370 L’Enfant Administration (FDA) has determined A regulatory review period consists of
the regulatory review period for two periods of time: A testing phase and
Promenade SW., Washington, DC 20447,
RAVICTI and is publishing this notice an approval phase. For human drug
Attn: ACF Reports Clearance Officer.
of that determination as required by products, the testing phase begins when
Email address: infocollection@
law. FDA has made the determination the exemption to permit the clinical
acf.hhs.gov. All requests should be
because of the submission of an investigations of the drug becomes
identified by the title of the information
application to the Director of the U.S. effective and runs until the approval
collection. phase begins. The approval phase starts
The Department specifically requests Patent and Trademark Office (USPTO),
Department of Commerce, for the with the initial submission of an
comments on: (a) Whether the proposed application to market the human drug
extension of a patent which claims that
collection of information is necessary product and continues until FDA grants
human drug product.
for the proper performance of the permission to market the drug product.
functions of the agency, including ADDRESSES: Submit electronic
Although only a portion of a regulatory
whether the information shall have comments to http:// review period may count toward the
practical utility; (b) the accuracy of the www.regulations.gov. Submit written actual amount of extension that the
agency’s estimate of the burden of the petitions (two copies are required) and Director of USPTO may award (for
proposed collection of information; (c) written comments to the Division of example, half the testing phase must be
the quality, utility, and clarity of the Dockets Management (HFA–305), Food subtracted as well as any time that may
information to be collected; and (d) and Drug Administration, 5630 Fishers have occurred before the patent was
ways to minimize the burden of the Lane, rm. 1061, Rockville, MD 20852. issued), FDA’s determination of the
collection of information on Submit petitions electronically to length of a regulatory review period for
respondents, including through the use http://www.regulations.gov at Docket a human drug product will include all
No. FDA–2013–S–0610. of the testing phase and approval phase
of automated collection techniques or
other forms of information technology. FOR FURTHER INFORMATION CONTACT: as specified in 35 U.S.C. 156(g)(1)(B).
Consideration will be given to Beverly Friedman, Office of FDA has approved for marketing the
Management, Food and Drug
tkelley on DSK3SPTVN1PROD with NOTICES

comments and suggestions submitted human drug product RAVICTI (glycerol
within 60 days of this publication. Administration, 10001 New Hampshire phenylbutyrate). RAVICTI is indicated
Ave., Hillandale Campus Rm. 3180, for use as a nitrogen-binding agent for
Robert Sargis, Silver Spring, MD 20993, 301–796– chronic management of adult and
Reports Clearance Officer. 7900. pediatric patients 2 years of age or older
[FR Doc. 2015–08842 Filed 4–16–15; 8:45 am] SUPPLEMENTARY INFORMATION: The Drug with urea cycle disorders that cannot be
BILLING CODE 4184–01–P Price Competition and Patent Term managed by dietary protein restriction

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Document Created: 2015-12-18 11:19:45
Document Modified: 2015-12-18 11:19:45

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.
Contact		Beverly Friedman, Office of Management, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Campus Rm. 3180, Silver Spring, MD 20993, 301-796-7900.
FR Citation		80 FR 21247

80 FR 21247 - Determination of Regulatory Review Period for Purposes of Patent Extension; RAVICTI

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 74 (April 17, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration