80_FR_76930 80 FR 76693 - Determination of Regulatory Review Period for Purposes of Patent Extension; FULYZAQ

80 FR 76693 - Determination of Regulatory Review Period for Purposes of Patent Extension; FULYZAQ

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 237 (December 10, 2015)

Page Range76693-76694
FR Document2015-31097

The Food and Drug Administration (FDA) has determined the regulatory review period for FULYZAQ 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 237 (Thursday, December 10, 2015) 
[Federal Register Volume 80, Number 237 (Thursday, December 10, 2015)]
[Notices]
[Pages 76693-76694]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-31097]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2014-E-0308 and FDA-2014-E-0309]


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

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 FULYZAQ 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 
February 8, 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 June 7, 2016. 
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 Nos. 
FDA-2014-E-0308 and FDA-2014-E-0309 for ``Determination of Regulatory 
Review Period for Purposes of Patent Extension; FULYZAQ.'' Received 
comments will be placed in the dockets 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

[[Page 76694]]

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 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 FULYZAQ 
(crofelemer). FULYZAQ is indicated for the symptomatic relief of non-
infectious diarrhea in adult patients with HIV/AIDS on anti-retroviral 
therapy. Subsequent to this approval, the USPTO received a patent term 
restoration application for FULYZAQ (U.S. Patent No. 7,323,195) from 
Napo Pharmaceuticals, Inc., and the USPTO requested FDA's assistance in 
determining this patent's eligibility for patent term restoration. In a 
letter dated May 23, 2014, FDA advised the USPTO that this human drug 
product had undergone a regulatory review period and that the approval 
of FULYZAQ 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 
FULYZAQ is 7,784 days. Of this time, 7,391 days occurred during the 
testing phase of the regulatory review period, while 393 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: September 11, 1991. The applicant claims August 14, 1991, as 
the date the investigational new drug application (IND) became 
effective. However, FDA records indicate that the IND effective date 
was September 11, 1991, which was 30 days after FDA receipt of the 
first IND from the sponsor for this new drug.
    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 
5, 2011. The applicant claims December 16, 2011, as the date the new 
drug application (NDA) for FULYZAQ (NDA 202292) was initially 
submitted. However, FDA records indicate that NDA 202292 was submitted 
on December 5, 2011.
    3. The date the application was approved: December 31, 2012. FDA 
has verified the applicant's claim that NDA 202292 was approved on 
December 31, 2012.
    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.

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. 
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: December 4, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-31097 Filed 12-9-15; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 237 / Thursday, December 10, 2015 / Notices 76693 CDC is also requesting an adjustment Finally, CDC is requesting the The resulting change in burden is a to the burden associated with reports of addition of the Passenger Locator Form reduction of 3,611 hours. communicable disease or death from to this information collection. CDC Estimated Annualized Burden Hours domestic conveyances. CDC is reducing currently has approval to collect the the burden from 15 minutes per report Passenger Locator Form from travelers CDC anticipates this information to 7 minutes. This is due to the aboard international flights under OMB collection will result in 90 total burden facilitation of reporting using electronic Control Number 0920–0134. CDC is hours from 1,000 respondents. There is means, i.e. Air Traffic Control and the requesting approval to collect passenger no burden to respondents other than the Domestic Events Network for domestic contact and locating information for time required to complete and send the requested information to CDC. The flights, rather than the hard copy Master travelers aboard domestic flights within estimated annualized burden is 90 of Vessel or Conveyance Illness Report. the United States. hours. ESTIMATED ANNUALIZED BURDEN HOURS Average Number of Number of burden per Type of respondent Form name responses per respondents response respondent (in hours) Master of a vessel or person in charge of a 42 CFR 70.4 Report by the master of a ves- 200 1 7/60 conveyance. sel or person in charge of conveyance of the incidence of a communicable disease occurring while in interstate travel. Traveler ........................................................... Passenger Locator Form ............................... 800 1 5/60 Leroy A. Richardson, Furthermore, any interested person may Written/Paper Submissions Chief, Information Collection Review Office, petition FDA for a determination Submit written/paper submissions as Office of Scientific Integrity, Office of the regarding whether the applicant for Associate Director for Science, Office of the follows: extension acted with due diligence Director, Centers for Disease Control and • Mail/Hand delivery/Courier (for during the regulatory review period by Prevention. written/paper submissions): Division of June 7, 2016. See ‘‘Petitions’’ in the [FR Doc. 2015–31105 Filed 12–9–15; 8:45 am] Dockets Management (HFA–305), Food SUPPLEMENTARY INFORMATION section for and Drug Administration, 5630 Fishers BILLING CODE 4163–18–P more information. Lane, Rm. 1061, Rockville, MD 20852. ADDRESSES: You may submit comments • For written/paper comments DEPARTMENT OF HEALTH AND as follows: submitted to the Division of Dockets HUMAN SERVICES Electronic Submissions Management, FDA will post your comment, as well as any attachments, Food and Drug Administration Submit electronic comments in the except for information submitted, following way: marked and identified, as confidential, [Docket Nos. FDA–2014–E–0308 and FDA– • Federal eRulemaking Portal: http:// if submitted as detailed in 2014–E–0309] www.regulations.gov. Follow the ‘‘Instructions.’’ Determination of Regulatory Review instructions for submitting comments. Instructions: All submissions received Period for Purposes of Patent Comments submitted electronically, must include the Docket Nos. FDA– Extension; FULYZAQ including attachments, to http:// 2014–E–0308 and FDA–2014–E–0309 www.regulations.gov will be posted to for ‘‘Determination of Regulatory AGENCY: Food and Drug Administration, the docket unchanged. Because your Review Period for Purposes of Patent HHS. comment will be made public, you are Extension; FULYZAQ.’’ Received ACTION: Notice. solely responsible for ensuring that your comments will be placed in the dockets comment does not include any and, except for those submitted as SUMMARY: The Food and Drug confidential information that you or a ‘‘Confidential Submissions,’’ publicly Administration (FDA) has determined third party may not wish to be posted, viewable at http://www.regulations.gov the regulatory review period for such as medical information, your or or at the Division of Dockets FULYZAQ and is publishing this notice anyone else’s Social Security number, or Management between 9 a.m. and 4 p.m., of that determination as required by confidential business information, such Monday through Friday. law. FDA has made the determination as a manufacturing process. Please note • Confidential Submissions—To because of the submission of an that if you include your name, contact submit a comment with confidential application to the Director of the U.S. information, or other information that information that you do not wish to be Patent and Trademark Office (USPTO), identifies you in the body of your made publicly available, submit your Department of Commerce, for the comments, that information will be comments only as a written/paper extension of a patent which claims that posted on http://www.regulations.gov. mstockstill on DSK4VPTVN1PROD with NOTICES submission. You should submit two human drug product. • If you want to submit a comment copies total. One copy will include the DATES: Anyone with knowledge that any with confidential information that you information you claim to be confidential of the dates as published (in the do not wish to be made available to the with a heading or cover note that states SUPPLEMENTARY INFORMATION section) are public, submit the comment as a ‘‘THIS DOCUMENT CONTAINS incorrect may submit either electronic written/paper submission and in the CONFIDENTIAL INFORMATION’’. The or written comments and ask for a manner detailed (see ‘‘Written/Paper Agency will review this copy, including redetermination by February 8, 2016. Submissions’’ and ‘‘Instructions’’). the claimed confidential information, in VerDate Sep<11>2014 19:33 Dec 09, 2015 Jkt 238001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\10DEN1.SGM 10DEN1

76694 Federal Register / Vol. 80, No. 237 / Thursday, December 10, 2015 / Notices its consideration of comments. The with the initial submission of an application (NDA) for FULYZAQ (NDA second copy, which will have the application to market the human drug 202292) was initially submitted. claimed confidential information product and continues until FDA grants However, FDA records indicate that redacted/blacked out, will be available permission to market the drug product. NDA 202292 was submitted on for public viewing and posted on http:// Although only a portion of a regulatory December 5, 2011. www.regulations.gov. Submit both review period may count toward the 3. The date the application was copies to the Division of Dockets actual amount of extension that the approved: December 31, 2012. FDA has Management. If you do not wish your Director of USPTO may award (for verified the applicant’s claim that NDA name and contact information to be example, half the testing phase must be 202292 was approved on December 31, made publicly available, you can subtracted as well as any time that may 2012. provide this information on the cover have occurred before the patent was This determination of the regulatory sheet and not in the body of your issued), FDA’s determination of the review period establishes the maximum comments and you must identify this length of a regulatory review period for potential length of a patent extension. information as ‘‘confidential.’’ Any a human drug product will include all However, the USPTO applies several information marked as ‘‘confidential’’ of the testing phase and approval phase statutory limitations in its calculations will not be disclosed except in as specified in 35 U.S.C. 156(g)(1)(B). of the actual period for patent extension. accordance with 21 CFR 10.20 and other FDA has approved for marketing the human drug product FULYZAQ III. Petitions applicable disclosure law. For more information about FDA’s posting of (crofelemer). FULYZAQ is indicated for Anyone with knowledge that any of comments to public dockets, see 80 FR the symptomatic relief of non-infectious the dates as published are incorrect may 56469, September 18, 2015, or access diarrhea in adult patients with HIV/ submit either electronic or written the information at: http://www.fda.gov/ AIDS on anti-retroviral therapy. comments and ask for a redetermination regulatoryinformation/dockets/ Subsequent to this approval, the USPTO (see DATES). Furthermore, any interested default.htm. received a patent term restoration person may petition FDA for a Docket: For access to the docket to application for FULYZAQ (U.S. Patent determination regarding whether the read background documents or the No. 7,323,195) from Napo applicant for extension acted with due electronic and written/paper comments Pharmaceuticals, Inc., and the USPTO diligence during the regulatory review received, go to http:// requested FDA’s assistance in period. To meet its burden, the petition www.regulations.gov and insert the determining this patent’s eligibility for must be timely (see DATES) and contain docket number, found in brackets in the patent term restoration. In a letter dated sufficient facts to merit an FDA heading of this document, into the May 23, 2014, FDA advised the USPTO investigation. (See H. Rept. 857, part 1, ‘‘Search’’ box and follow the prompts that this human drug product had 98th Cong., 2d sess., pp. 41–42, 1984.) and/or go to the Division of Dockets undergone a regulatory review period Petitions should be in the format Management, 5630 Fishers Lane, Rm. and that the approval of FULYZAQ specified in 21 CFR 10.30. 1061, Rockville, MD 20852. represented the first permitted Submit petitions electronically to commercial marketing or use of the http://www.regulations.gov at Docket FOR FURTHER INFORMATION CONTACT: product. Thereafter, the USPTO No. FDA–2013–S–0610. Submit written Beverly Friedman, Office of Regulatory requested that FDA determine the Policy, Food and Drug Administration, petitions (two copies are required) to the product’s regulatory review period. Division of Dockets Management (HFA– 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, II. Determination of Regulatory Review 305), Food and Drug Administration, 301–796–3600. Period 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Petitions that have not been SUPPLEMENTARY INFORMATION: FDA has determined that the made publicly available on http:// applicable regulatory review period for I. Background www.regulations.gov may be viewed in FULYZAQ is 7,784 days. Of this time, The Drug Price Competition and the Division of Dockets Management 7,391 days occurred during the testing Patent Term Restoration Act of 1984 between 9 a.m. and 4 p.m., Monday phase of the regulatory review period, (Pub. L. 98–417) and the Generic through Friday. while 393 days occurred during the Animal Drug and Patent Term approval phase. These periods of time Dated: December 4, 2015. Restoration Act (Pub. L. 100–670) were derived from the following dates: Leslie Kux, generally provide that a patent may be 1. The date an exemption under Associate Commissioner for Policy. extended for a period of up to 5 years section 505(i) of the Federal Food, Drug, [FR Doc. 2015–31097 Filed 12–9–15; 8:45 am] so long as the patented item (human and Cosmetic Act (the FD&C Act) (21 BILLING CODE 4164–01–P drug product, animal drug product, U.S.C. 355(i)) became effective: medical device, food additive, or color September 11, 1991. The applicant additive) was subject to regulatory claims August 14, 1991, as the date the DEPARTMENT OF HEALTH AND review by FDA before the item was investigational new drug application HUMAN SERVICES marketed. Under these acts, a product’s (IND) became effective. However, FDA regulatory review period forms the basis records indicate that the IND effective Food and Drug Administration for determining the amount of extension date was September 11, 1991, which an applicant may receive. was 30 days after FDA receipt of the [Docket No. FDA–2014–E–0265] mstockstill on DSK4VPTVN1PROD with NOTICES A regulatory review period consists of first IND from the sponsor for this new two periods of time: A testing phase and drug. Determination of Regulatory Review an approval phase. For human drug 2. The date the application was Period for Purposes of Patent products, the testing phase begins when initially submitted with respect to the Extension; SIRTURO the exemption to permit the clinical human drug product under section AGENCY: Food and Drug Administration, investigations of the drug becomes 505(b) of the FD&C Act: December 5, HHS. effective and runs until the approval 2011. The applicant claims December ACTION: Notice. phase begins. The approval phase starts 16, 2011, as the date the new drug VerDate Sep<11>2014 19:33 Dec 09, 2015 Jkt 238001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\10DEN1.SGM 10DEN1


Document Created: 2015-12-14 13:28:52
Document Modified: 2015-12-14 13:28:52
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesAnyone 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 February 8, 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 June 7, 2016. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information.
ContactBeverly 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 Citation80 FR 76693 
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