Determination of Regulatory Review Period for Purposes of Patent Extension; QUTENZA, 47399-47400 [2016-17187]

Download as PDF 47399 Federal Register / Vol. 81, No. 140 / Thursday, July 21, 2016 / Notices presentation materials at public meetings. FDA will publish ERG’s assessments, with interview results and findings, in the Federal Register for public comment. 60-day notice requesting public comment on the proposed extension of this collection of information. No comments were received. We estimate the burden of this collection of information as follows: Description of Respondents: The respondents to this collection of information are sponsor representatives for NME NDAs and original BLAs. In the Federal Register of December 10, 2015 (80 FR 76699), we published a TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Portion of study Number of responses per respondent Total annual responses Average burden per response Total hours Pre-test ................................................................................. Interviews ............................................................................. 5 135 1 1 5 135 1.5 1.5 7.50 202.50 Total .............................................................................. ........................ ........................ ........................ ........................ 210 1 There are no capital costs or operating and maintenance costs associated with this collection of information. FDA typically reviews approximately 40 to 45 NME NDAs and original BLAs per year. ERG interviews 1 to 3 sponsor representatives at a time for each application that receives a first-cycle action from FDA, up to 135 sponsor representatives per year. ERG conducts a pretest of the interview protocol with five respondents. FDA estimates that it will take 1.0 to 1.5 hours to complete the pretest, for a total of a maximum of 7.5 hours. We estimate that up to 135 respondents will take part in the postaction interviews each year, with each interview lasting 1.0 to 1.5 hours, for a total of a maximum of 202.5 hours. Thus, the total estimated annual burden is 210 hours. FDA’s burden estimate is based on prior experience with similar interviews with the regulated community. Dated: July 14, 2016. Leslie Kux, Associate Commissioner for Policy. Electronic Submissions [FR Doc. 2016–17185 Filed 7–20–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–E–0406] Determination of Regulatory Review Period for Purposes of Patent Extension; QUTENZA AGENCY: Food and Drug Administration, asabaliauskas on DSK3SPTVN1PROD with NOTICES HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined the regulatory review period for QUTENZA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an SUMMARY: VerDate Sep<11>2014 17:15 Jul 20, 2016 Jkt 238001 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. 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 September 19, 2016. 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 January 17, 2017. See ‘‘Petitions’’ in the SUPPLEMENTARY INFORMATION section for more information. ADDRESSES: You may submit comments as follows: Submit electronic comments in the following way: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http:// 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 http://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 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– 2010–E–0406 for ‘‘Determination of Regulatory Review Period for Purposes of Patent Extension; QUTENZA.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at http://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 E:\FR\FM\21JYN1.SGM 21JYN1 47400 Federal Register / Vol. 81, No. 140 / Thursday, July 21, 2016 / Notices redacted/blacked out, will be available for public viewing and posted on http:// 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: http://www.fda.gov/ regulatoryinformation/dockets/ default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http:// 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: asabaliauskas on DSK3SPTVN1PROD with NOTICES 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 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 VerDate Sep<11>2014 17:15 Jul 20, 2016 Jkt 238001 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 QUTENZA (capsaicin). QUTENZA is indicated for management of neuropathic pain associated with postherpetic neuralgia. Subsequent to this approval, the USPTO received a patent term restoration application for QUTENZA (U.S. Patent No. 6,239,180) from NeurogesX, Inc., and the USPTO requested FDA’s assistance in determining this patent’s eligibility for patent term restoration and also requested that FDA determine the product’s regulatory review period. In a letter dated June 23, 2016, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of QUTENZA represented the first permitted commercial marketing or use of the product. Thereafter, FDA also determined the product’s regulatory review period. II. Determination of Regulatory Review Period FDA has determined that the applicable regulatory review period for QUTENZA is 2,944 days. Of this time, 2,547 days occurred during the testing phase of the regulatory review period, while 397 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: October 27, 2001. The applicant claims September 27, 2001, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was October 27, 2001, 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 FD&C Act: October 16, 2008. The applicant claims October 13, 2008, as the date the new drug application (NDA) for QUTENZA was initially submitted. However, FDA records indicate that NDA 22–395 was submitted on October 16, 2008. PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 3. The date the application was approved: November 16, 2009. FDA has verified the applicant’s claim that NDA 22–395 was approved on November 16, 2009. 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 1,687 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 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 DATES) 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 http://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: July 14, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–17187 Filed 7–20–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant E:\FR\FM\21JYN1.SGM 21JYN1

Agencies

[Federal Register Volume 81, Number 140 (Thursday, July 21, 2016)]
[Notices]
[Pages 47399-47400]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17187]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-E-0406]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for QUTENZA 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.

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 
September 19, 2016. 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 January 17, 
2017. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for 
more information.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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-2010-E-0406 for ``Determination of Regulatory Review Period for 
Purposes of Patent Extension; QUTENZA.'' Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at http://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

[[Page 47400]]

redacted/blacked out, will be available for public viewing and posted 
on http://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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 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 QUTENZA 
(capsaicin). QUTENZA is indicated for management of neuropathic pain 
associated with postherpetic neuralgia. Subsequent to this approval, 
the USPTO received a patent term restoration application for QUTENZA 
(U.S. Patent No. 6,239,180) from NeurogesX, Inc., and the USPTO 
requested FDA's assistance in determining this patent's eligibility for 
patent term restoration and also requested that FDA determine the 
product's regulatory review period. In a letter dated June 23, 2016, 
FDA advised the USPTO that this human drug product had undergone a 
regulatory review period and that the approval of QUTENZA represented 
the first permitted commercial marketing or use of the product. 
Thereafter, FDA also determined the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for 
QUTENZA is 2,944 days. Of this time, 2,547 days occurred during the 
testing phase of the regulatory review period, while 397 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: October 27, 2001. The applicant claims September 27, 2001, 
as the date the investigational new drug application (IND) became 
effective. However, FDA records indicate that the IND effective date 
was October 27, 2001, 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 FD&C Act: October 
16, 2008. The applicant claims October 13, 2008, as the date the new 
drug application (NDA) for QUTENZA was initially submitted. However, 
FDA records indicate that NDA 22-395 was submitted on October 16, 2008.
    3. The date the application was approved: November 16, 2009. FDA 
has verified the applicant's claim that NDA 22-395 was approved on 
November 16, 2009.
    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 1,687 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 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 DATES) 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 http://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: July 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-17187 Filed 7-20-16; 8:45 am]
 BILLING CODE 4164-01-P