81_FR_37723 81 FR 37611 - Determination of Regulatory Review Period for Purposes of Patent Extension; TANZEUM

81 FR 37611 - Determination of Regulatory Review Period for Purposes of Patent Extension; TANZEUM

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 112 (June 10, 2016)

Page Range37611-37612
FR Document2016-13797

The Food and Drug Administration (FDA) has determined the regulatory review period for TANZEUM 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 81 Issue 112 (Friday, June 10, 2016) 
[Federal Register Volume 81, Number 112 (Friday, June 10, 2016)]
[Notices]
[Pages 37611-37612]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-13797]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-E-2341]


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

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 TANZEUM 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 (in the 
SUPPLEMENTARY INFORMATION section) are incorrect may submit either 
electronic or written comments and ask for a redetermination by August 
9, 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 December 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 No. 
FDA-2014-E-2341
    For Determination of Regulatory Review Period for Purposes of 
Patent Extension; TANZEUM. 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 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 biological products, the 
testing phase begins when the exemption to permit the clinical 
investigations of the biological becomes effective and runs until the 
approval phase 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

[[Page 37612]]

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 biological product TANZEUM 
(albiglutide). TANZEUM is indicated as an adjunct to diet and exercise 
to improve glycemic control in adults with type 2 diabetes mellitus. 
Subsequent to this approval, the U.S. Patent and Trademark Office 
(USPTO) received a patent term restoration application for TANZEUM 
(U.S. Patent No. 7,141,547) from Human Genome Sciences, Inc., and the 
USPTO requested FDA's assistance in determining this patent's 
eligibility for patent term restoration. In a letter dated May 11, 
2015, FDA advised the USPTO that this human biological product had 
undergone a regulatory review period and that the approval of TANZEUM 
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 
TANZEUM is 3,014 days. Of this time, 2,557 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 (the FD&C Act) (21 U.S.C. 355(i)) became 
effective: January 15, 2006. FDA has verified the applicant's claim 
that the date the investigational new drug application (IND) became 
effective was on January 15, 2006.
    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): January 14, 2013. The applicant claims 
January 11, 2013, as the date the biologics license application (BLA) 
for TANZEUM (BLA 125431) was initially submitted. However, FDA records 
indicate that BLA 125431 was received by FDA on January 14, 2013.
    3. The date the application was approved: April 15, 2014. FDA has 
verified the applicant's claim that BLA 125431 was approved on April 
15, 2014.
    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 1,577 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: June 3, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-13797 Filed 6-9-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Notices 37611 Dated: June 3, 2016. as a manufacturing process. Please note information as ‘‘confidential.’’ Any Jill Hartzler Warner, that if you include your name, contact information marked as ‘‘confidential’’ Associate Commissioner for Special Medical information, or other information that will not be disclosed except in Programs. identifies you in the body of your accordance with 21 CFR 10.20 and other [FR Doc. 2016–13733 Filed 6–9–16; 8:45 am] comments, that information will be applicable disclosure law. For more BILLING CODE 4164–01–P posted on http://www.regulations.gov. information about FDA’s posting of • If you want to submit a comment comments to public dockets, see 80 FR with confidential information that you 56469, September 18, 2015, or access DEPARTMENT OF HEALTH AND do not wish to be made available to the the information at: http://www.fda.gov/ HUMAN SERVICES public, submit the comment as a regulatoryinformation/dockets/ written/paper submission and in the default.htm. Food and Drug Administration manner detailed (see ‘‘Written/Paper Docket: For access to the docket to [Docket No. FDA–2014–E–2341] Submissions’’ and ‘‘Instructions’’). read background documents or the Written/Paper Submissions electronic and written/paper comments Determination of Regulatory Review received, go to http:// Period for Purposes of Patent Submit written/paper submissions as www.regulations.gov and insert the Extension; TANZEUM follows: docket number, found in brackets in the • Mail/Hand delivery/Courier (for heading of this document, into the AGENCY: Food and Drug Administration, written/paper submissions): Division of ‘‘Search’’ box and follow the prompts HHS. Dockets Management (HFA–305), Food and/or go to the Division of Dockets ACTION: Notice. and Drug Administration, 5630 Fishers Management, 5630 Fishers Lane, Rm. Lane, Rm. 1061, Rockville, MD 20852. 1061, Rockville, MD 20852. SUMMARY: The Food and Drug • For written/paper comments Administration (FDA) has determined submitted to the Division of Dockets FOR FURTHER INFORMATION CONTACT: the regulatory review period for Management, FDA will post your Beverly Friedman, Office of Regulatory TANZEUM and is publishing this notice comment, as well as any attachments, Policy, Food and Drug Administration, of that determination as required by except for information submitted, 10903 New Hampshire Ave. Bldg. 51, law. FDA has made the determination marked and identified, as confidential, Rm. 6250, Silver Spring, MD 20993, because of the submission of an if submitted as detailed in 301–796–3600. application to the Director of the U.S. ‘‘Instructions.’’ SUPPLEMENTARY INFORMATION: Patent and Trademark Office (USPTO), Instructions: All submissions received Department of Commerce, for the I. Background must include the Docket No. FDA– extension of a patent which claims that 2014–E–2341 The Drug Price Competition and human biological product. For Determination of Regulatory Patent Term Restoration Act of 1984 DATES: Anyone with knowledge that any Review Period for Purposes of Patent (Pub. L. 98–417) and the Generic of the dates as published (in the Extension; TANZEUM. Received Animal Drug and Patent Term SUPPLEMENTARY INFORMATION section) are comments will be placed in the docket Restoration Act (Pub. L. 100–670) incorrect may submit either electronic and, except for those submitted as generally provide that a patent may be or written comments and ask for a ‘‘Confidential Submissions,’’ publicly extended for a period of up to 5 years redetermination by August 9, 2016. viewable at http://www.regulations.gov so long as the patented item (human Furthermore, any interested person may or at the Division of Dockets drug product, animal drug product, petition FDA for a determination Management between 9 a.m. and 4 p.m., medical device, food additive, or color regarding whether the applicant for Monday through Friday. additive) was subject to regulatory extension acted with due diligence • Confidential Submissions—To review by FDA before the item was during the regulatory review period by submit a comment with confidential marketed. Under these acts, a product’s December 7, 2016. See ‘‘Petitions’’ in information that you do not wish to be regulatory review period forms the basis the SUPPLEMENTARY INFORMATION section made publicly available, submit your for determining the amount of extension for more information. comments only as a written/paper an applicant may receive. ADDRESSES: You may submit comments submission. You should submit two A regulatory review period consists of as follows: copies total. One copy will include the two periods of time: A testing phase and information you claim to be confidential an approval phase. For human Electronic Submissions with a heading or cover note that states biological products, the testing phase Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS begins when the exemption to permit following way: CONFIDENTIAL INFORMATION’’. The the clinical investigations of the • Federal eRulemaking Portal: http:// Agency will review this copy, including biological becomes effective and runs www.regulations.gov. Follow the the claimed confidential information, in until the approval phase begins. The instructions for submitting comments. its consideration of comments. The approval phase starts with the initial Comments submitted electronically, second copy, which will have the submission of an application to market including attachments, to http:// claimed confidential information the human biological product and www.regulations.gov will be posted to redacted/blacked out, will be available continues until FDA grants permission the docket unchanged. Because your for public viewing and posted on http:// to market the biological product. asabaliauskas on DSK3SPTVN1PROD with NOTICES comment will be made public, you are www.regulations.gov. Submit both Although only a portion of a regulatory solely responsible for ensuring that your copies to the Division of Dockets review period may count toward the comment does not include any Management. If you do not wish your actual amount of extension that the confidential information that you or a name and contact information to be Director of USPTO may award (for third party may not wish to be posted, made publicly available, you can example, half the testing phase must be such as medical information, your or provide this information on the cover subtracted as well as any time that may anyone else’s Social Security number, or sheet and not in the body of your have occurred before the patent was confidential business information, such comments and you must identify this issued), FDA’s determination of the VerDate Sep<11>2014 19:02 Jun 09, 2016 Jkt 238001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\10JNN1.SGM 10JNN1

37612 Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Notices length of a regulatory review period for In its application for patent extension, individualized risk-assessments and a human drug product will include all this applicant seeks 1,577 days of patent counseling services, developing and of the testing phase and approval phase term extension. disseminating the most current as specified in 35 U.S.C. 156(g)(1)(B). education to providers and the public, FDA has approved for marketing the III. Petitions improving access to information for human biological product TANZEUM Anyone with knowledge that any of hard-to-reach populations, and (albiglutide). TANZEUM is indicated as the dates as published are incorrect may supporting a national network of an adjunct to diet and exercise to submit either electronic or written resources with centers accessible to improve glycemic control in adults with comments and ask for a redetermination each of the 10 HRSA regions. type 2 diabetes mellitus. Subsequent to (see DATES). Furthermore, any interested SUPPLEMENTARY INFORMATION: this approval, the U.S. Patent and person may petition FDA for a Intended Recipient of the Award: Trademark Office (USPTO) received a determination regarding whether the Organization of Teratology Information patent term restoration application for applicant for extension acted with due Specialists. TANZEUM (U.S. Patent No. 7,141,547) diligence during the regulatory review from Human Genome Sciences, Inc., period. To meet its burden, the petition Amount of Non-Competitive Awards: and the USPTO requested FDA’s must be timely (see DATES) and contain $1,100,000. assistance in determining this patent’s sufficient facts to merit an FDA Period of Supplemental Funding: 9/1/ eligibility for patent term restoration. In investigation. (See H. Rept. 857, part 1, 2016–8/31/2017. a letter dated May 11, 2015, FDA 98th Cong., 2d sess., pp. 41–42, 1984.) CFDA Number: 93.110. advised the USPTO that this human Petitions should be in the format Authority: Social Security Act, Title V, biological product had undergone a specified in 21 CFR 10.30. § 501(a)(2); (42 U.S.C. 701(a)(2)). regulatory review period and that the Submit petitions electronically to Justification: REHN activities are approval of TANZEUM represented the http://www.regulations.gov at Docket essential to achieving HHS Healthy first permitted commercial marketing or No. FDA–2013–S–0610. Submit written People 2020 goals related to improving use of the product. Thereafter, the petitions (two copies are required) to the preconception care, preventing maternal USPTO requested that FDA determine Division of Dockets Management (HFA– morbidity and mortality, reducing infant the product’s regulatory review period. 305), Food and Drug Administration, mortality, and reducing health 5630 Fishers Lane, Rm. 1061, Rockville, disparities in perinatal health. During II. Determination of Regulatory Review MD 20852. this extension period of the budget Period Dated: June 3, 2016. period (9/1/2016–8/31/2017), MCHB FDA has determined that the applicable regulatory review period for Leslie Kux, plans to issue a new FOA that will align TANZEUM is 3,014 days. Of this time, Associate Commissioner for Policy. HRSA’s work in this area with work 2,557 days occurred during the testing [FR Doc. 2016–13797 Filed 6–9–16; 8:45 am] funded by the Environmental Protection phase of the regulatory review period, BILLING CODE 4164–01–P Agency (EPA) and the Centers for while 457 days occurred during the Disease Control and Prevention’s (CDC) approval phase. These periods of time through their jointly funded Pediatric were derived from the following dates: DEPARTMENT OF HEALTH AND Environmental Health Specialty Unit 1. The date an exemption under HUMAN SERVICES Program (PEHSU). Aligning REHN and section 505(i) of the Federal Food, Drug, PEHSU will result in a more and Cosmetic Act (the FD&C Act) (21 Health Resources and Services comprehensive HHS initiative to U.S.C. 355(i)) became effective: January Administration expand access to services and maximize 15, 2006. FDA has verified the limited resources in this area. During Reproductive and Environmental this time, OTIS would continue to applicant’s claim that the date the Health Network investigational new drug application provide individualized risk-assessments (IND) became effective was on January AGENCY: Health Resources and Services and counseling services, developing and 15, 2006. Administration, HHS. disseminating the most current 2. The date the application was ACTION: Notice of a Single-Award education to providers and the public, initially submitted with respect to the Deviation from Competition improving access to information for human biological product under section Requirements for the Reproductive and hard-to-reach populations, and 351 of the Public Health Service Act (42 Environmental Health Network. supporting a national network of U.S.C. 262): January 14, 2013. The resources with centers accessible to applicant claims January 11, 2013, as SUMMARY: HRSA announces the award each of the 10 HRSA regions. the date the biologics license of an extension in the amount of MCHB proposes to initiate a one-time application (BLA) for TANZEUM (BLA $1,100,000 for the Reproductive and 12 month extension for the budget 125431) was initially submitted. Environmental Health Network (REHN) period of 9/1/2016 to 8/31/2017 with However, FDA records indicate that cooperative agreement. The purpose of $1,100,000 in FY 2016 funds to the BLA 125431 was received by FDA on the REHN is to improve maternal and OTIS REHN cooperative agreement. The January 14, 2013. fetal health outcomes by providing extension would allow the OTIS to 3. The date the application was evidence-based information on the continue to provide evidence-based approved: April 15, 2014. FDA has safety of exposures in pregnancy and information on the safety of exposures asabaliauskas on DSK3SPTVN1PROD with NOTICES verified the applicant’s claim that BLA lactation. The extension will permit the in pregnancy and lactation through 125431 was approved on April 15, 2014. Organization of Teratology Information individualized risk-assessments and This determination of the regulatory Specialists (OTIS), the cooperative counseling services, developing and review period establishes the maximum agreement awardee, during the budget disseminating the most current potential length of a patent extension. period of 9/1/2016–8/31/2017, to education to providers and the public, However, the USPTO applies several continue to provide evidence-based improving access to information for statutory limitations in its calculations information on the safety of exposures hard-to-reach populations, and of the actual period for patent extension. in pregnancy and lactation through supporting a national network of VerDate Sep<11>2014 19:02 Jun 09, 2016 Jkt 238001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\10JNN1.SGM 10JNN1


Document Created: 2018-02-08 07:36:03
Document Modified: 2018-02-08 07:36:03
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 August 9, 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 December 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 Citation81 FR 37611 
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