81 FR 40316 - Determination of Regulatory Review Period for Purposes of Patent Extension; XOFIGO
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 119 (June 21, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 119 (June 21, 2016)
| Page Range | 40316-40317 | |
| FR Document | 2016-14551 |
[Federal Register Volume 81, Number 119 (Tuesday, June 21, 2016)] [Notices] [Pages 40316-40317] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-14551] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-E-2335] Determination of Regulatory Review Period for Purposes of Patent Extension; XOFIGO AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for XOFIGO 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 August 22, 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 19, 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-2335 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; XOFIGO.'' 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 [[Page 40317]] 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 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 XOFIGO (radium 223 dichloride). XOFIGO is indicated for treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. Subsequent to this approval, the USPTO received a patent term restoration application for XOFIGO (U.S. Patent No. 6,635,234) from Algeta ASA, and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated March 19, 2015, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of XOFIGO 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 XOFIGO is 1,945 days. Of this time, 1,792 days occurred during the testing phase of the regulatory review period, while 153 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 19, 2008. Algeta ASA claims that February 21, 2008, is the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was January 19, 2008, 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: December 14, 2012. FDA has verified the applicant's claim that the new drug application (NDA) for XOFIGO (NDA 203971) was initially submitted on December 14, 2012. 3. The date the application was approved: May 15, 2013. FDA has verified the applicant's claim that NDA 203971 was approved on May 15, 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 1,032 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 15, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-14551 Filed 6-20-16; 8:45 am] BILLING CODE 4164-01-P
![40316 Federal Register / Vol. 81, No. 119 / Tuesday, June 21, 2016 / Notices
approval under the submission type FDA estimates the burden of this
applicable to the parent device. collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response
Accessory classification de novo request ............................ 8 1 8 180 1,440
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Respondents are medical device DEPARTMENT OF HEALTH AND confidential information that you or a
manufacturers seeking to market device HUMAN SERVICES third party may not wish to be posted,
accessories. Of the approximately 41 de such as medical information, your or
novo applications received per year, Food and Drug Administration anyone else’s Social Security number, or
only 2 have been associated with [Docket No. FDA–2014–E–2335] confidential business information, such
accessories. With heightened awareness as a manufacturing process. Please note
of the availability of the de novo Determination of Regulatory Review that if you include your name, contact
pathway for accessories, we expect to Period for Purposes of Patent information, or other information that
receive four to six additional accessories Extension; XOFIGO identifies you in the body of your
comments, that information will be
applications per year. Therefore, we AGENCY: Food and Drug Administration, posted on http://www.regulations.gov.
estimate that we will receive HHS. • If you want to submit a comment
approximately eight accessory with confidential information that you
ACTION: Notice.
classification de novo requests per year. do not wish to be made available to the
Based on estimates by FDA SUMMARY: The Food and Drug public, submit the comment as a
administrative and technical staff who Administration (FDA) has determined written/paper submission and in the
are familiar with the proposed the regulatory review period for manner detailed (see ‘‘Written/Paper
submission process for accessory XOFIGO and is publishing this notice of Submissions’’ and ‘‘Instructions’’).
classification requests and on our that determination as required by law.
FDA has made the determination Written/Paper Submissions
burden estimate for a similar
information collection request (see ‘‘De because of the submission of an Submit written/paper submissions as
Novo Classification Process Evaluation application to the Director of the U.S. follows:
of Automatic Class III Designation; Draft Patent and Trademark Office (USPTO), • Mail/Hand delivery/Courier (for
Guidance for Industry and Food and Department of Commerce, for the written/paper submissions): Division of
extension of a patent which claims that Dockets Management (HFA–305), Food
Drug Administration Staff;
human drug product. and Drug Administration, 5630 Fishers
Availability,’’ 79 FR 47651 at 47653,
DATES: Anyone with knowledge that any
Lane, Rm. 1061, Rockville, MD 20852.
August 14, 2014), we estimate that the • For written/paper comments
submission process for each accessory of the dates as published (in the
submitted to the Division of Dockets
classification request will take SUPPLEMENTARY INFORMATION section) are
Management, FDA will post your
approximately 180 hours. incorrect may submit either electronic
comment, as well as any attachments,
or written comments and ask for a except for information submitted,
The draft guidance also refers to redetermination by August 22, 2016.
previously approved collections of marked and identified, as confidential,
Furthermore, any interested person may if submitted as detailed in
information found in FDA regulations. petition FDA for a determination
The collections of information in 21 ‘‘Instructions.’’
regarding whether the applicant for Instructions: All submissions received
CFR parts 801 and 809 have been extension acted with due diligence must include the Docket No. FDA–
approved under OMB control number during the regulatory review period by 2014–E–2335 for ‘‘Determination of
0910–0485; the collections of December 19, 2016. See ‘‘Petitions’’ in Regulatory Review Period for Purposes
information in 21 CFR part 807, subpart the SUPPLEMENTARY INFORMATION section of Patent Extension; XOFIGO.’’ Received
E have been approved under OMB for more information. comments will be placed in the docket
control number 0910–0120; the ADDRESSES: You may submit comments and, except for those submitted as
collections of information in 21 CFR as follows: ‘‘Confidential Submissions,’’ publicly
part 814 have been approved under viewable at http://www.regulations.gov
OMB control number 0910–0231; and Electronic Submissions
or at the Division of Dockets
the collections of information in 21 CFR Submit electronic comments in the Management between 9 a.m. and 4 p.m.,
part 860, subpart C, have been approved following way: Monday through Friday.
under OMB control number 0910–0138. • Federal eRulemaking Portal: http:// • Confidential Submissions—To
www.regulations.gov. Follow the submit a comment with confidential
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Dated: June 15, 2016.
instructions for submitting comments. information that you do not wish to be
Leslie Kux, Comments submitted electronically, made publicly available, submit your
Associate Commissioner for Policy. including attachments, to http:// comments only as a written/paper
[FR Doc. 2016–14562 Filed 6–20–16; 8:45 am] www.regulations.gov will be posted to submission. You should submit two
BILLING CODE 4164–01–P the docket unchanged. Because your copies total. One copy will include the
comment will be made public, you are information you claim to be confidential
solely responsible for ensuring that your with a heading or cover note that states
comment does not include any ‘‘THIS DOCUMENT CONTAINS
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![Federal Register / Vol. 81, No. 119 / Tuesday, June 21, 2016 / Notices 40317
CONFIDENTIAL INFORMATION.’’ The investigations of the drug becomes (NDA) for XOFIGO (NDA 203971) was
Agency will review this copy, including effective and runs until the approval initially submitted on December 14,
the claimed confidential information, in phase begins. The approval phase starts 2012.
its consideration of comments. The with the initial submission of an 3. The date the application was
second copy, which will have the application to market the human drug approved: May 15, 2013. FDA has
claimed confidential information product and continues until FDA grants verified the applicant’s claim that NDA
redacted/blacked out, will be available permission to market the drug product. 203971 was approved on May 15, 2013.
for public viewing and posted on http:// Although only a portion of a regulatory This determination of the regulatory
www.regulations.gov. Submit both review period may count toward the review period establishes the maximum
copies to the Division of Dockets actual amount of extension that the potential length of a patent extension.
Management. If you do not wish your Director of USPTO may award (for However, the USPTO applies several
name and contact information to be example, half the testing phase must be statutory limitations in its calculations
made publicly available, you can subtracted as well as any time that may of the actual period for patent extension.
provide this information on the cover have occurred before the patent was In its application for patent extension,
sheet and not in the body of your issued), FDA’s determination of the this applicant seeks 1,032 days of patent
comments and you must identify this length of a regulatory review period for term extension.
information as ‘‘confidential.’’ Any a human drug product will include all III. Petitions
information marked as ‘‘confidential’’ of the testing phase and approval phase
will not be disclosed except in as specified in 35 U.S.C. 156(g)(1)(B). Anyone with knowledge that any of
accordance with 21 CFR 10.20 and other FDA has approved for marketing the the dates as published are incorrect may
applicable disclosure law. For more human drug product XOFIGO (radium submit either electronic or written
information about FDA’s posting of 223 dichloride). XOFIGO is indicated comments and ask for a redetermination
comments to public dockets, see 80 FR for treatment of patients with castration- (see DATES). Furthermore, any interested
56469, September 18, 2015, or access resistant prostate cancer, symptomatic person may petition FDA for a
the information at: http://www.fda.gov/ bone metastases and no known visceral determination regarding whether the
regulatoryinformation/dockets/ metastatic disease. Subsequent to this applicant for extension acted with due
default.htm. approval, the USPTO received a patent diligence during the regulatory review
Docket: For access to the docket to term restoration application for XOFIGO period. To meet its burden, the petition
read background documents or the (U.S. Patent No. 6,635,234) from Algeta must be timely (see DATES) and contain
electronic and written/paper comments ASA, and the USPTO requested FDA’s sufficient facts to merit an FDA
received, go to http:// assistance in determining this patent’s investigation. (See H. Rept. 857, part 1,
www.regulations.gov and insert the eligibility for patent term restoration. In 98th Cong., 2d sess., pp. 41–42, 1984.)
docket number, found in brackets in the a letter dated March 19, 2015, FDA Petitions should be in the format
heading of this document, into the advised the USPTO that this human specified in 21 CFR 10.30.
drug product had undergone a Submit petitions electronically to
‘‘Search’’ box and follow the prompts
regulatory review period and that the http://www.regulations.gov at Docket
and/or go to the Division of Dockets
approval of XOFIGO represented the No. FDA–2013–S–0610. Submit written
Management, 5630 Fishers Lane, Rm.
first permitted commercial marketing or petitions (two copies are required) to the
1061, Rockville, MD 20852.
use of the product. Thereafter, the Division of Dockets Management (HFA–
FOR FURTHER INFORMATION CONTACT: 305), Food and Drug Administration,
USPTO requested that FDA determine
Beverly Friedman, Office of Regulatory the product’s regulatory review period. 5630 Fishers Lane, Rm. 1061, Rockville,
Policy, Food and Drug Administration, MD 20852.
10903 New Hampshire Ave., Bldg. 51, II. Determination of Regulatory Review
Rm. 6250, Silver Spring, MD 20993, Period Dated: June 15, 2016.
301–796–3600. Leslie Kux,
FDA has determined that the
Associate Commissioner for Policy.
SUPPLEMENTARY INFORMATION: applicable regulatory review period for
XOFIGO is 1,945 days. Of this time, [FR Doc. 2016–14551 Filed 6–20–16; 8:45 am]
I. Background
1,792 days occurred during the testing BILLING CODE 4164–01–P
The Drug Price Competition and phase of the regulatory review period,
Patent Term Restoration Act of 1984 while 153 days occurred during the
(Pub. L. 98–417) and the Generic approval phase. These periods of time DEPARTMENT OF HEALTH AND
Animal Drug and Patent Term were derived from the following dates: HUMAN SERVICES
Restoration Act (Pub. L. 100–670) 1. The date an exemption under Food and Drug Administration
generally provide that a patent may be section 505(i) of the Federal Food, Drug,
extended for a period of up to 5 years and Cosmetic Act (the FD&C Act) (21 [Docket No. FDA–2015–D–1376]
so long as the patented item (human U.S.C. 355(i)) became effective: January
drug product, animal drug product, 19, 2008. Algeta ASA claims that Leveraging Existing Clinical Data for
medical device, food additive, or color February 21, 2008, is the date the Extrapolation to Pediatric Uses of
additive) was subject to regulatory investigational new drug application Medical Devices; Guidance for
review by FDA before the item was (IND) became effective. However, FDA Industry and Food and Drug
marketed. Under these acts, a product’s records indicate that the IND effective Administration Staff; Availability
asabaliauskas on DSK3SPTVN1PROD with NOTICES
regulatory review period forms the basis date was January 19, 2008, which was AGENCY: Food and Drug Administration,
for determining the amount of extension 30 days after FDA receipt of the IND. HHS.
an applicant may receive. 2. The date the application was ACTION: Notice of availability.
A regulatory review period consists of initially submitted with respect to the
two periods of time: A testing phase and human drug product under section SUMMARY: The Food and Drug
an approval phase. For human drug 505(b) of the FD&C Act: December 14, Administration (FDA or Agency) is
products, the testing phase begins when 2012. FDA has verified the applicant’s announcing the availability of the final
the exemption to permit the clinical claim that the new drug application guidance entitled ‘‘Leveraging Existing
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Document Created: 2016-06-21 01:30:38
Document Modified: 2016-06-21 01:30:38
| 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 (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by August 22, 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 19, 2016. 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 | 81 FR 40316 |
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