83 FR 2459 - Determination of Regulatory Review Period for Purposes of Patent Extension; AXUMIN
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 11 (January 17, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 11 (January 17, 2018)
| Page Range | 2459-2461 | |
| FR Document | 2018-00684 |
[Federal Register Volume 83, Number 11 (Wednesday, January 17, 2018)] [Notices] [Pages 2459-2461] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-00684] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-E-3619] Determination of Regulatory Review Period for Purposes of Patent Extension; AXUMIN AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for AXUMIN 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 March 19, 2018. 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 July 16, 2018. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before March 19, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of March 19, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// [[Page 2460]] 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 https://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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, 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-2016-E-3619 for ''Determination of Regulatory Review Period for Purposes of Patent Extension; AXUMIN.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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 Sec. 10.20 (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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 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 AXUMIN (fluciclovine F-18). AXUMIN is indicated for positron emission tomography imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen levels following prior treatment. Subsequent to this approval, the USPTO received a patent term restoration application for AXUMIN (U.S. Patent No. 5,808,146) from Emory University, and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated December 1, 2016, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of AXUMIN 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 AXUMIN is 4,006 days. Of this time, 3,763 days occurred during the testing phase of the regulatory review period, while 243 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 (FD&C Act) (21 U.S.C. 355(i)) became effective: June 10, 2005. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on June 10, 2005 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: September 28, 2015. FDA has verified the applicant's claim that the new drug application (NDA) for AXUMIN (NDA 208054) was initially submitted on September 28, 2015. 3. The date the application was approved: May 27, 2016. FDA has verified the applicant's claim that NDA 208054 was approved on May 27, 2016. [[Page 2461]] 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 5 years 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, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in Sec. 60.30 (21 CFR 60.30), 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 comply with all the requirements of Sec. 60.30, including but not limited to: must be timely (see DATES), must be filed in accordance with Sec. 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (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 https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: January 11, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-00684 Filed 1-16-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 11 / Wednesday, January 17, 2018 / Notices 2459
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
Number of disclosures Total annual
21 CFR section, activity Average burden per disclosure Total hours
respondents per disclosures
respondent
558.6(b)(3)–(5) and (b)(7)-(9); re- 3,050 246 750,000 .125 (7 minutes) ............................... 93,750
quired disclosures when a veteri-
narian issues a VFD.
558.6(c)(8); required disclosure (ac- 1,000 5 5,000 .125 (7 minutes) ............................... 625
knowledgement letter) from one
distributor to another.
Total ........................................... ........................ ........................ ........................ ........................................................... 94,375
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The VFD regulation also contains drug(s) as a component.’’ (List specific SUMMARY: The Food and Drug
several labeling provisions that are approved, conditionally approved, or Administration (FDA or the Agency) has
exempt from OMB review and approval indexed combination medicated feeds determined the regulatory review period
under the PRA because they are a following this statement. for AXUMIN and is publishing this
‘‘public disclosure of information § 558.6(b)(6)(ii).) notice of that determination as required
originally supplied by the Federal 3. ‘‘This VFD authorizes the use of the by law. FDA has made the
government to the recipient for the VFD drug(s) cited in this order in any determination because of the
purpose of disclosure to the public’’ (5 FDA-approved, conditionally approved, submission of an application to the
CFR 1320.3(c)(2)) and therefore do not or indexed combination(s) in medicated Director of the U.S. Patent and
constitute a ‘‘collection of information’’ feed that contains the VFD drug(s) as a Trademark Office (USPTO), Department
under the PRA (44 U.S.C. 3501, et seq.). component’’ (§ 558.6(b)(6)(iii)). of Commerce, for the extension of a
All labeling and advertising for VFD These labeling statements are not patent which claims that human drug
drugs, combination VFD drugs, and subject to review by OMB because, as product.
feeds containing VFD drugs or stated previously, they are a ‘‘public
combination VFD drugs must DATES: Anyone with knowledge that any
disclosure of information originally of the dates as published (in the
prominently and conspicuously display supplied by the Federal government to SUPPLEMENTARY INFORMATION section) are
the following cautionary statement: the recipient for the purpose of
‘‘Caution: Federal law restricts incorrect may submit either electronic
disclosure to the public’’ (5 CFR or written comments and ask for a
medicated feed containing this 1320.3(c)(2)) and therefore do not
veterinary feed directive (VFD) drug to redetermination by March 19, 2018.
constitute a ‘‘collection of information’’ Furthermore, any interested person may
use by or on the order of a licensed under the PRA (44 U.S.C. 3501, et seq.).
veterinarian’’ (§ 558.6(a)(6)). In addition, petition FDA for a determination
Our estimate of the annual burden for regarding whether the applicant for
the veterinarian must ensure that the this information collection has not
following statement is included on the extension acted with due diligence
changed since the last OMB approval, during the regulatory review period by
VFD (§ 558.6(b)(3)(xiii)): ‘‘Use of feed which was associated with the June 3,
containing this veterinary feed directive July 16, 2018. See ‘‘Petitions’’ in the
2015, final rule. However, the one-time SUPPLEMENTARY INFORMATION section for
(VFD) drug in a manner other than as burdens that we included in our
directed on the labeling (extralabel use) more information.
analysis of the June 3, 2015, final rule
is not permitted.’’ (80 FR 31708 at 31729 to 31732) are not ADDRESSES: You may submit comments
The veterinarian may restrict VFD included in our current estimate. as follows. Please note that late,
authorization to only include the VFD untimely filed comments will not be
Dated: January 11, 2018. considered. Electronic comments must
drug(s) cited on the VFD or such
authorization may be expanded to allow Leslie Kux, be submitted on or before March 19,
the use of the cited VFD drug(s) along Associate Commissioner for Policy. 2018. The https://www.regulations.gov
with one or more over-the-counter [FR Doc. 2018–00676 Filed 1–16–18; 8:45 am] electronic filing system will accept
animal drugs in an approved, BILLING CODE 4164–01–P comments until midnight Eastern Time
conditionally approved, or indexed at the end of March 19, 2018. Comments
combination VFD drug (§ 558.6(b)(6)). received by mail/hand delivery/courier
The veterinarian must affirm his or her DEPARTMENT OF HEALTH AND (for written/paper submissions) will be
intent regarding combination VFD drugs HUMAN SERVICES considered timely if they are
by including one of the following postmarked or the delivery service
statements on the VFD: Food and Drug Administration acceptance receipt is on or before that
1. ‘‘This VFD only authorizes the use date.
of the VFD drug(s) cited in this order [Docket No. FDA–2016–E–3619]
Electronic Submissions
and is not intended to authorize the use
ethrower on DSK3G9T082PROD with NOTICES
of such drug(s) in combination with any Determination of Regulatory Review Submit electronic comments in the
other animal drugs’’ (§ 558.6(b)(6)(i)). Period for Purposes of Patent following way:
2. ‘‘This VFD authorizes the use of the Extension; AXUMIN • Federal eRulemaking Portal:
VFD drug(s) cited in this order in the AGENCY: Food and Drug Administration, https://www.regulations.gov. Follow the
following FDA-approved, conditionally HHS. instructions for submitting comments.
approved, or indexed combination(s) in Comments submitted electronically,
ACTION: Notice.
medicated feed that contains the VFD including attachments, to https://
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![Federal Register / Vol. 83, No. 11 / Wednesday, January 17, 2018 / Notices 2461
This determination of the regulatory regulations, we, the U.S. Fish and population or the species, keeping in
review period establishes the maximum Wildlife Service, have developed a draft mind the carrying capacity of the habitat
potential length of a patent extension. revised marine mammal stock and the health of the ecosystem of
However, the USPTO applies several assessment report for the northern sea which they form a constituent element’’
statutory limitations in its calculations otter stock in the State of Washington. (16 U.S.C. 1362(9)).
of the actual period for patent extension. We now make the draft stock To help accomplish the goal of
In its application for patent extension, assessment report available for public maintaining marine mammal stocks at
this applicant seeks 5 years of patent review and comment. their OSPs, section 117 of the MMPA
term extension. DATES: We will consider comments that requires the Service and the National
are received or postmarked on or before Marine Fisheries Service (NMFS) to
III. Petitions prepare a SAR for each marine mammal
April 17, 2018.
Anyone with knowledge that any of ADDRESSES: If you wish to review the
stock that occurs in waters under U.S.
the dates as published are incorrect may draft revised stock assessment report for jurisdiction. A SAR must be based on
submit either electronic or written the northern sea otter stock in the best scientific information available;
comments and, under 21 CFR 60.24, ask Washington, you may obtain a copy therefore, we prepare it in consultation
for a redetermination (see DATES). from our website at http://www.fws.gov/ with established regional scientific
Furthermore, as specified in § 60.30 (21 wafwo. Alternatively, you may contact review groups established under 117(d)
CFR 60.30), any interested person may the Washington Fish and Wildlife of the MMPA. Each SAR must include:
petition FDA for a determination Office, 510 Desmond Dr., Suite 102, 1. A description of the stock and its
regarding whether the applicant for Lacey, WA 98503 (telephone: 360–753– geographic range;
extension acted with due diligence 9440). If you wish to comment on the 2. A minimum population estimate,
during the regulatory review period. To current and maximum net productivity rate,
stock assessment report, you may and current population trend;
meet its burden, the petition must submit your comments in writing by
comply with all the requirements of 3. An estimate of the annual human-caused
any one of the following methods: mortality and serious injury by source and,
§ 60.30, including but not limited to: • U.S. mail: State Supervisor, at the for a strategic stock, other factors that may be
must be timely (see DATES), must be above address; causing a decline or impeding recovery of the
filed in accordance with § 10.20, must • Hand delivery: Washington Fish stock;
contain sufficient facts to merit an FDA and Wildlife Office at the above address; 4. A description of commercial fishery
investigation, and must certify that a • Fax: 360–753–9565; or interactions;
true and complete copy of the petition • Email: fw1_waseaottersar@fws.gov. 5. A categorization of the status of the
has been served upon the patent stock; and
FOR FURTHER INFORMATION CONTACT: 6. An estimate of the potential biological
applicant. (See H. Rept. 857, part 1, 98th Deanna Lynch, at the above street removal (PBR) level.
Cong., 2d sess., pp. 41–42, 1984.) address, by telephone (360–753–9545),
Petitions should be in the format The MMPA defines the PBR as ‘‘the
or by email (deanna_lynch@fws.gov).
specified in 21 CFR 10.30. maximum number of animals, not
Persons who use a telecommunications
Submit petitions electronically to including natural mortalities, that may
device for the deaf (TDD) may call the
https://www.regulations.gov at Docket be removed from a marine mammal
Federal Relay Service at 800–877–8339.
No. FDA–2013–S–0610. Submit written stock while allowing that stock to reach
SUPPLEMENTARY INFORMATION: We or maintain its [OSP]’’ (16 U.S.C.
petitions (two copies are required) to the
announce the availability for review and 1362(20)). The PBR is the product of the
Dockets Management Staff (HFA–305),
comment of a draft revised marine minimum population estimate of the
Food and Drug Administration, 5630
mammal stock assessment report (SAR) stock (Nmin); one-half the maximum
Fishers Lane, Rm. 1061, Rockville, MD
for the northern sea otter (Enhydra lutris theoretical or estimated net productivity
20852.
kenyoni) stock in the State of rate of the stock at a small population
Dated: January 11, 2018. Washington. size (Rmax); and a recovery factor (Fr) of
Leslie Kux, between 0.1 and 1.0, which is intended
Background
Associate Commissioner for Policy. to compensate for uncertainty and
[FR Doc. 2018–00684 Filed 1–16–18; 8:45 am] Under the Marine Mammal Protection
unknown estimation errors. This can be
Act of 1972, as amended (MMPA; 16
BILLING CODE 4164–01–P written as:
U.S.C. 1361 et seq.), and its
implementing regulations in the Code of PBR = (Nmin)(1⁄2 of the Rmax)(Fr)
Federal Regulations (CFR) at 50 CFR Section 117 of the MMPA also
DEPARTMENT OF THE INTERIOR
part 18, the U.S. Fish and Wildlife requires the Service and NMFS to
Fish and Wildlife Service Service (Service) regulates the taking; review the SARs (a) at least annually for
import; and, under certain conditions, stocks that are specified as strategic
[FWS–R1–ES–2017–N135; FF01EWFW00– possession; transportation; purchasing; stocks, (b) at least annually for stocks for
FXES111601M000] selling; and offering for sale, purchase, which significant new information is
or export, of marine mammals. One of available, and (c) at least once every 3
Marine Mammal Protection Act; Stock
the goals of the MMPA is to ensure that years for all other stocks. If our review
Assessment Report for the Northern
stocks of marine mammals occurring in of the status of a stock indicates that it
Sea Otter in Washington
waters under U.S. jurisdiction do not has changed or may be more accurately
AGENCY: Fish and Wildlife Service, experience a level of human-caused determined, then the SAR must be
ethrower on DSK3G9T082PROD with NOTICES
Interior. mortality and serious injury that is revised accordingly.
ACTION: Notice of availability; request likely to cause the stock to be reduced A strategic stock is defined in the
for comments. below its optimum sustainable MMPA as a marine mammal stock ‘‘(A)
population (OSP) level. OSP is defined for which the level of direct human-
SUMMARY: In accordance with the under the MMPA as ‘‘the number of caused mortality exceeds the [PBR]
Marine Mammal Protection Act of 1972, animals which will result in the level; (B) which, based on the best
as amended, and its implementing maximum productivity of the available scientific information, is
VerDate Sep<11>2014 17:14 Jan 16, 2018 Jkt 244001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\17JAN1.SGM 17JAN1](https://thefederalregister.org/doc/83_FR_2470/page/3.svg)
Document Created: 2018-10-26 09:56:19
Document Modified: 2018-10-26 09:56:19
| 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 March 19, 2018. 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 July 16, 2018. 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 | 83 FR 2459 |
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