83_FR_7770 83 FR 7734 - Determination of Regulatory Review Period for Purposes of Patent Extension; LYMPHOSEEK

83 FR 7734 - Determination of Regulatory Review Period for Purposes of Patent Extension; LYMPHOSEEK

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 36 (February 22, 2018)

Page Range7734-7735
FR Document2018-03610

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LYMPHOSEEK 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 83 Issue 36 (Thursday, February 22, 2018) 
[Federal Register Volume 83, Number 36 (Thursday, February 22, 2018)]
[Notices]
[Pages 7734-7735]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-03610]



[[Page 7734]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-E-0940]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has 
determined the regulatory review period for LYMPHOSEEK 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 April 
23, 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 August 21, 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 April 23, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of April 23, 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://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-2014-E-0940 for ``Determination of Regulatory Review Period for 
Purposes of Patent Extension; LYMPHOSEEK.'' 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

[[Page 7735]]

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 LYMPHOSEEK 
(technetium (Tc 99m) tilmanocept). LYMPHOSEEK is indicated for 
lymphatic mapping with a hand-held gamma counter to assist in the 
localization of lymph nodes draining a primary tumor site in patients 
with breast cancer or melanoma. Subsequent to this approval, the USPTO 
received a patent term restoration application for LYMPHOSEEK (U.S. 
Patent No. 6,409,990) from Navidea Biopharmaceuticals, Inc., and the 
USPTO requested FDA's assistance in determining this patent's 
eligibility for patent term restoration. In a letter dated November 4, 
2015, FDA advised the USPTO that this human drug product had undergone 
a regulatory review period and that the approval of LYMPHOSEEK 
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 
LYMPHOSEEK is 4,398 days. Of this time, 3,816 days occurred during the 
testing phase of the regulatory review period, while 582 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: February 28, 2001. FDA has verified the applicant's claim 
that the date the investigational new drug application became effective 
was on February 28, 2001.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the FD&C Act: August 10, 
2011. FDA has verified the applicant's claim that the new drug 
application (NDA) for LYMPHOSEEK (NDA 202207) was initially submitted 
on August 10, 2011.
    3. The date the application was approved: March 13, 2013. FDA has 
verified the applicant's claim that NDA 202207 was approved on March 
13, 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 1,826 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 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: February 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03610 Filed 2-21-18; 8:45 am]
 BILLING CODE 4164-01-P

7734 Federal Register / Vol. 83, No. 36 / Thursday, February 22, 2018 / Notices DEPARTMENT OF HEALTH AND solely responsible for ensuring that your both copies to the Dockets Management HUMAN SERVICES comment does not include any Staff. If you do not wish your name and confidential information that you or a contact information to be made publicly Food and Drug Administration third party may not wish to be posted, available, you can provide this [Docket No. FDA–2014–E–0940] such as medical information, your or information on the cover sheet and not anyone else’s Social Security number, or in the body of your comments and you Determination of Regulatory Review confidential business information, such must identify this information as Period for Purposes of Patent as a manufacturing process. Please note ‘‘confidential.’’ Any information marked Extension; LYMPHOSEEK that if you include your name, contact as ‘‘confidential’’ will not be disclosed information, or other information that except in accordance with § 10.20 (21 AGENCY: Food and Drug Administration, identifies you in the body of your CFR 10.20) and other applicable HHS. comments, that information will be disclosure law. For more information ACTION: Notice. posted on https://www.regulations.gov. about FDA’s posting of comments to • If you want to submit a comment public dockets, see 80 FR 56469, SUMMARY: The Food and Drug with confidential information that you September 18, 2015, or access the Administration (FDA or the Agency) has do not wish to be made available to the information at: https://www.gpo.gov/ determined the regulatory review period public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015- for LYMPHOSEEK and is publishing written/paper submission and in the 23389.pdf. this notice of that determination as manner detailed (see ‘‘Written/Paper Docket: For access to the docket to required by law. FDA has made the Submissions’’ and ‘‘Instructions’’). read background documents or the determination because of the electronic and written/paper comments Written/Paper Submissions submission of an application to the received, go to https:// Director of the U.S. Patent and Submit written/paper submissions as www.regulations.gov and insert the Trademark Office (USPTO), Department follows: docket number, found in brackets in the of Commerce, for the extension of a • Mail/Hand delivery/Courier (for heading of this document, into the patent which claims that human drug written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts product. Management Staff (HFA–305), Food and and/or go to the Dockets Management Drug Administration, 5630 Fishers DATES: Anyone with knowledge that any Staff, 5630 Fishers Lane, Rm. 1061, Lane, Rm. 1061, Rockville, MD 20852. of the dates as published (in the • For written/paper comments Rockville, MD 20852. SUPPLEMENTARY INFORMATION section) are submitted to the Dockets Management FOR FURTHER INFORMATION CONTACT: incorrect may submit either electronic Staff, FDA will post your comment, as Beverly Friedman, Office of Regulatory or written comments and ask for a well as any attachments, except for Policy, Food and Drug Administration, redetermination by April 23, 2018. information submitted, marked and 10903 New Hampshire Ave., Bldg. 51, Furthermore, any interested person may identified, as confidential, if submitted Rm. 6250, Silver Spring, MD 20993, petition FDA for a determination as detailed in ‘‘Instructions.’’ 301–796–3600. regarding whether the applicant for Instructions: All submissions received SUPPLEMENTARY INFORMATION: extension acted with due diligence must include the Docket No. FDA– during the regulatory review period by 2014–E–0940 for ‘‘Determination of I. Background August 21, 2018. See ‘‘Petitions’’ in the Regulatory Review Period for Purposes The Drug Price Competition and SUPPLEMENTARY INFORMATION section for of Patent Extension; LYMPHOSEEK.’’ Patent Term Restoration Act of 1984 more information. Received comments, those filed in a (Pub. L. 98–417) and the Generic ADDRESSES: You may submit comments timely manner (see ADDRESSES), will be Animal Drug and Patent Term as follows. Please note that late, placed in the docket and, except for Restoration Act (Pub. L. 100–670) untimely filed comments will not be those submitted as ‘‘Confidential generally provide that a patent may be considered. Electronic comments must Submissions,’’ publicly viewable at extended for a period of up to 5 years be submitted on or before April 23, https://www.regulations.gov or at the so long as the patented item (human 2018. The https://www.regulations.gov Dockets Management Staff between 9 drug product, animal drug product, electronic filing system will accept a.m. and 4 p.m., Monday through medical device, food additive, or color comments until midnight Eastern Time Friday. additive) was subject to regulatory at the end of April 23, 2018. Comments • Confidential Submissions—To review by FDA before the item was received by mail/hand delivery/courier submit a comment with confidential marketed. Under these acts, a product’s (for written/paper submissions) will be information that you do not wish to be regulatory review period forms the basis considered timely if they are made publicly available, submit your for determining the amount of extension postmarked or the delivery service comments only as a written/paper an applicant may receive. acceptance receipt is on or before that submission. You should submit two A regulatory review period consists of date. 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 drug Electronic Submissions with a heading or cover note that states products, the testing phase begins when Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS the exemption to permit the clinical following way: CONFIDENTIAL INFORMATION.’’ The investigations of the drug becomes • Federal eRulemaking Portal: Agency will review this copy, including effective and runs until the approval daltland on DSKBBV9HB2PROD with NOTICES https://www.regulations.gov. Follow the the claimed confidential information, in phase begins. The approval phase starts instructions for submitting comments. its consideration of comments. The with the initial submission of an Comments submitted electronically, second copy, which will have the application to market the human drug including attachments, to https:// claimed confidential information product and continues until FDA grants www.regulations.gov will be posted to redacted/blacked out, will be available permission to market the drug product. the docket unchanged. Because your for public viewing and posted on Although only a portion of a regulatory comment will be made public, you are https://www.regulations.gov. Submit review period may count toward the VerDate Sep<11>2014 20:10 Feb 21, 2018 Jkt 244001 PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 E:\FR\FM\22FEN1.SGM 22FEN1

Federal Register / Vol. 83, No. 36 / Thursday, February 22, 2018 / Notices 7735 actual amount of extension that the 202207 was approved on March 13, announcing an opportunity for public Director of USPTO may award (for 2013. comment on the proposed collection of example, half the testing phase must be This determination of the regulatory certain information by the Agency. subtracted as well as any time that may review period establishes the maximum Under the Paperwork Reduction Act of have occurred before the patent was potential length of a patent extension. 1995 (PRA), Federal Agencies are issued), FDA’s determination of the However, the USPTO applies several required to publish notice in the length of a regulatory review period for statutory limitations in its calculations Federal Register concerning each a human drug product will include all of the actual period for patent extension. proposed collection of information, of the testing phase and approval phase In its application for patent extension, including each proposed extension of an as specified in 35 U.S.C. 156(g)(1)(B). this applicant seeks 1,826 days of patent existing collection of information, and FDA has approved for marketing the term extension. to allow 60 days for public comment in human drug product LYMPHOSEEK response to the notice. This notice III. Petitions (technetium (Tc 99m) tilmanocept). solicits comments on the reporting and LYMPHOSEEK is indicated for Anyone with knowledge that any of recordkeeping requirements of our lymphatic mapping with a hand-held the dates as published are incorrect may regulations concerning new animal gamma counter to assist in the submit either electronic or written comments and under 21 CFR 60.24, ask drugs for investigational use. localization of lymph nodes draining a primary tumor site in patients with for a redetermination (see DATES). DATES: Submit either electronic or breast cancer or melanoma. Subsequent Furthermore, as specified in § 60.30 (21 written comments on the collection of to this approval, the USPTO received a CFR 60.30), any interested person may information by April 23, 2018. patent term restoration application for petition FDA for a determination regarding whether the applicant for ADDRESSES: You may submit comments LYMPHOSEEK (U.S. Patent No. extension acted with due diligence as follows. Please note that late, 6,409,990) from Navidea during the regulatory review period. To untimely filed comments will not be Biopharmaceuticals, Inc., and the meet its burden, the petition must considered. Electronic comments must USPTO requested FDA’s assistance in determining this patent’s eligibility for comply with all the requirements of be submitted on or before April 23, patent term restoration. In a letter dated § 60.30, including but not limited to: 2018. The https://www.regulations.gov November 4, 2015, FDA advised the must be timely (see DATES), must be electronic filing system will accept USPTO that this human drug product filed in accordance with § 10.20, must comments until midnight Eastern Time had undergone a regulatory review contain sufficient facts to merit an FDA at the end of April 23, 2018. Comments period and that the approval of investigation, and must certify that a received by mail/hand delivery/courier LYMPHOSEEK represented the first true and complete copy of the petition (for written/paper submissions) will be permitted commercial marketing or use has been served upon the patent considered timely if they are of the product. Thereafter, the USPTO applicant. (See H. Rept. 857, part 1, 98th postmarked or the delivery service requested that FDA determine the Cong., 2d sess., pp. 41–42, 1984.) acceptance receipt is on or before that product’s regulatory review period. Petitions should be in the format date. specified in 21 CFR 10.30. Electronic Submissions II. Determination of Regulatory Review Submit petitions electronically to Period https://www.regulations.gov at Docket Submit electronic comments in the FDA has determined that the No. FDA–2013–S–0610. Submit written following way: applicable regulatory review period for petitions (two copies are required) to the • Federal eRulemaking Portal: LYMPHOSEEK is 4,398 days. Of this Dockets Management Staff (HFA–305), https://www.regulations.gov. Follow the time, 3,816 days occurred during the Food and Drug Administration, 5630 instructions for submitting comments. testing phase of the regulatory review Fishers Lane, Rm. 1061, Rockville, MD Comments submitted electronically, period, while 582 days occurred during 20852. including attachments, to https:// the approval phase. These periods of Dated: February 15, 2018. www.regulations.gov will be posted to time were derived from the following Leslie Kux, the docket unchanged. Because your dates: comment will be made public, you are Associate Commissioner for Policy. 1. The date an exemption under [FR Doc. 2018–03610 Filed 2–21–18; 8:45 am] solely responsible for ensuring that your section 505(i) of the Federal Food, Drug, comment does not include any and Cosmetic Act (the FD&C Act) (21 BILLING CODE 4164–01–P confidential information that you or a U.S.C. 355(i)) became effective: third party may not wish to be posted, February 28, 2001. FDA has verified the DEPARTMENT OF HEALTH AND such as medical information, your or applicant’s claim that the date the HUMAN SERVICES anyone else’s Social Security number, or investigational new drug application confidential business information, such became effective was on February 28, Food and Drug Administration as a manufacturing process. Please note 2001. 2. The date the application was [Docket No. FDA–2018–N–0341] that if you include your name, contact initially submitted with respect to the information, or other information that human drug product under section Agency Information Collection identifies you in the body of your 505(b) of the FD&C Act: August 10, Activities; Proposed Collection; comments, that information will be 2011. FDA has verified the applicant’s Comment Request; New Animal Drugs posted on https://www.regulations.gov. daltland on DSKBBV9HB2PROD with NOTICES claim that the new drug application for Investigational Use • If you want to submit a comment (NDA) for LYMPHOSEEK (NDA 202207) AGENCY: Food and Drug Administration, with confidential information that you was initially submitted on August 10, HHS. do not wish to be made available to the 2011. ACTION: Notice. public, submit the comment as a 3. The date the application was written/paper submission and in the approved: March 13, 2013. FDA has SUMMARY: The Food and Drug manner detailed (see ‘‘Written/Paper verified the applicant’s claim that NDA Administration (FDA, Agency, or we) is Submissions’’ and ‘‘Instructions’’). VerDate Sep<11>2014 20:10 Feb 21, 2018 Jkt 244001 PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 E:\FR\FM\22FEN1.SGM 22FEN1


Document Created: 2018-02-22 02:51:01
Document Modified: 2018-02-22 02:51:01
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 April 23, 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 August 21, 2018. 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 Citation83 FR 7734 
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