82_FR_56471 82 FR 56244 - Determination of Regulatory Review Period for Purposes of Patent Extension; RAPIVAB

82 FR 56244 - Determination of Regulatory Review Period for Purposes of Patent Extension; RAPIVAB

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 227 (November 28, 2017)

Page Range56244-56245
FR Document2017-25676

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for RAPIVAB and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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 82 Issue 227 (Tuesday, November 28, 2017) 
[Federal Register Volume 82, Number 227 (Tuesday, November 28, 2017)]
[Notices]
[Pages 56244-56245]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-25676]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2016-E-0533 and FDA-2016-E-0534]


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

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 RAPIVAB and is publishing 
this notice of that determination as required by law. FDA has made the 
determination because of the submission of applications 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 January 
29, 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 May 29, 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 January 29, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of January 29, 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 Nos. 
FDA-2016-E-0533 and FDA-2016-E-0534 for ''Determination of Regulatory 
Review Period for Purposes of Patent Extension; RAPIVAB.'' 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

[[Page 56245]]

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 RAPIVAB 
(peramivir). RAPIVAB is indicated for the treatment of acute 
uncomplicated influenza in patients 18 years and older who have been 
symptomatic for no more than two days. Subsequent to this approval, the 
USPTO received patent term restoration applications for RAPIVAB (U.S. 
Patent Nos. 6,503,745 and 6,562,861) from BioCryst Pharmaceuticals, 
Inc., and the USPTO requested FDA's assistance in determining the 
patents' eligibility for patent term restoration. In a letter dated 
April 29, 2016, FDA advised the USPTO that this human drug product had 
undergone a regulatory review period and that the approval of RAPIVAB 
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 
RAPIVAB is 3,287 days. Of this time, 2,925 days occurred during the 
testing phase of the regulatory review period, while 362 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: December 21, 2005. FDA has verified the BioCryst 
Pharmaceuticals, Inc. claims that December 21, 2005, is the date the 
investigational new drug application (IND) became effective.
    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 
23, 2013. FDA has verified the applicant's claims that the new drug 
application (NDA) for RAPIVAB (NDA 206426) was initially submitted on 
December 23, 2013.
    3. The date the application was approved: December 19, 2014. FDA 
has verified the applicant's claim that NDA 206426 was approved on 
December 19, 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 applications for patent extension, 
this applicant seeks 1,824 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: November 22, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-25676 Filed 11-27-17; 8:45 am]
 BILLING CODE 4164-01-P

56244 Federal Register / Vol. 82, No. 227 / Tuesday, November 28, 2017 / Notices Plan; Use: Under sections 1401, 1411, DEPARTMENT OF HEALTH AND comment will be made public, you are and 1412 of the Affordable Care Act and HUMAN SERVICES solely responsible for ensuring that your 45 CFR part 155 subpart D, an Exchange comment does not include any makes an advance determination of tax Food and Drug Administration confidential information that you or a credit eligibility for individuals who third party may not wish to be posted, [Docket Nos. FDA–2016–E–0533 and FDA– enroll in QHP coverage through the 2016–E–0534] such as medical information, your or Exchange and seek financial assistance. anyone else’s Social Security number, or Using information available at the time Determination of Regulatory Review confidential business information, such of enrollment, the Exchange determines Period for Purposes of Patent as a manufacturing process. Please note Extension; RAPIVAB that if you include your name, contact whether the individual meets the information, or other information that income and other requirements for AGENCY: Food and Drug Administration, identifies you in the body of your advance payments and the amount of HHS. comments, that information will be the advance payments that can be used posted on https://www.regulations.gov. ACTION: Notice. to pay premiums. Advance payments • If you want to submit a comment are made periodically under section SUMMARY: The Food and Drug with confidential information that you 1412 of the Affordable Care Act to the Administration (FDA or the Agency) has do not wish to be made available to the issuer of the QHP in which the determined the regulatory review period public, submit the comment as a individual enrolls. Section 1402 of the for RAPIVAB and is publishing this written/paper submission and in the Affordable Care Act provides for the notice of that determination as required manner detailed (see ‘‘Written/Paper reduction of cost sharing for certain by law. FDA has made the Submissions’’ and ‘‘Instructions’’). individuals enrolled in a QHP through determination because of the Written/Paper Submissions an Exchange, and section 1412 of the submission of applications to the Affordable Care Act provides for the Director of the U.S. Patent and Submit written/paper submissions as advance payment of these reductions to Trademark Office (USPTO), Department follows: of Commerce, for the extension of a • Mail/Hand delivery/Courier (for issuers. The statute directs issuers to patent which claims that human drug written/paper submissions): Dockets reduce cost sharing for essential health Management Staff (HFA–305), Food and benefits for individuals with household product. Drug Administration, 5630 Fishers incomes between 100 and 400 percent DATES: Anyone with knowledge that any Lane, Rm. 1061, Rockville, MD 20852. of the Federal poverty level (FPL) who of the dates as published (in the • For written/paper comments are enrolled in a silver level QHP SUPPLEMENTARY INFORMATION section) are submitted to the Dockets Management through an individual market Exchange incorrect may submit either electronic Staff, FDA will post your comment, as and are eligible for advance payments of or written comments and ask for a well as any attachments, except for the premium tax credit. The data redetermination by January 29, 2018. information submitted, marked and collection will be used by HHS to make Furthermore, any interested person may identified, as confidential, if submitted payments or collect charges from issuers petition FDA for a determination as detailed in ‘‘Instructions.’’ under the following programs: advance regarding whether the applicant for Instructions: All submissions received payments of the premium tax credit, extension acted with due diligence must include the Docket Nos. FDA– advanced cost-sharing reductions, and during the regulatory review period by 2016–E–0533 and FDA–2016–E–0534 Marketplace user fees. The template will May 29, 2018. See ‘‘Petitions’’ in the for ’’Determination of Regulatory SUPPLEMENTARY INFORMATION section for Review Period for Purposes of Patent be used to make payments in January more information. Extension; RAPIVAB.’’ Received 2014 and for a number of months thereafter, as may be required based on ADDRESSES: You may submit comments comments, those filed in a timely HHS’s operational progress. Form as follows. Please note that late, manner (see ADDRESSES), will be placed untimely filed comments will not be in the docket and, except for those Number: CMS–10515 (OMB control considered. Electronic comments must submitted as ‘‘Confidential number: 0938–1217); Frequency: be submitted on or before January 29, Submissions,’’ publicly viewable at Monthly; Affected Public: Private sector 2018. The https://www.regulations.gov https://www.regulations.gov or at the (Business or other for-profits and not- electronic filing system will accept Dockets Management Staff between 9 for-profit institutions); Number of comments until midnight Eastern Time a.m. and 4 p.m., Monday through Respondents: 575; Total Annual at the end of January 29, 2018. Friday. Responses: 7,475; Total Annual Hours: Comments received by mail/hand • Confidential Submissions—To 51,175. (For policy questions regarding delivery/courier (for written/paper submit a comment with confidential this collection contact Jaya Ghildiyal at submissions) will be considered timely information that you do not wish to be 301–492–5149). if they are postmarked or the delivery made publicly available, submit your Dated: November 21, 2017. service acceptance receipt is on or comments only as a written/paper William N. Parham, III, before that date. submission. You should submit two copies total. One copy will include the Director, Paperwork Reduction Staff, Office Electronic Submissions information you claim to be confidential of Strategic Operations and Regulatory Submit electronic comments in the with a heading or cover note that states Affairs. following way: ‘‘THIS DOCUMENT CONTAINS ethrower on DSK3G9T082PROD with NOTICES [FR Doc. 2017–25612 Filed 11–27–17; 8:45 am] • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The BILLING CODE 4120–01–P https://www.regulations.gov. Follow the Agency will review this copy, including instructions for submitting comments. the claimed confidential information, in Comments submitted electronically, its consideration of comments. The including attachments, to https:// second copy, which will have the www.regulations.gov will be posted to claimed confidential information the docket unchanged. Because your redacted/blacked out, will be available VerDate Sep<11>2014 19:51 Nov 27, 2017 Jkt 244001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\28NON1.SGM 28NON1

Federal Register / Vol. 82, No. 227 / Tuesday, November 28, 2017 / Notices 56245 for public viewing and posted on Although only a portion of a regulatory 206426 was approved on December 19, https://www.regulations.gov. Submit review period may count toward the 2014. both copies to the Dockets Management actual amount of extension that the This determination of the regulatory Staff. If you do not wish your name and Director of USPTO may award (for review period establishes the maximum contact information to be made publicly example, half the testing phase must be potential length of a patent extension. available, you can provide this subtracted as well as any time that may However, the USPTO applies several information on the cover sheet and not have occurred before the patent was statutory limitations in its calculations in the body of your comments and you issued), FDA’s determination of the of the actual period for patent extension. must identify this information as length of a regulatory review period for In its applications for patent extension, ‘‘confidential.’’ Any information marked a human drug product will include all this applicant seeks 1,824 days of patent as ‘‘confidential’’ will not be disclosed of the testing phase and approval phase term extension. except in accordance with § 10.20 (21 as specified in 35 U.S.C. 156(g)(1)(B). III. Petitions CFR 10.20) and other applicable FDA has approved for marketing the disclosure law. For more information human drug product RAPIVAB Anyone with knowledge that any of about FDA’s posting of comments to (peramivir). RAPIVAB is indicated for the dates as published are incorrect may public dockets, see 80 FR 56469, submit either electronic or written the treatment of acute uncomplicated September 18, 2015, or access the comments and, under 21 CFR 60.24, ask influenza in patients 18 years and older information at: https://www.gpo.gov/ for a redetermination (see DATES). who have been symptomatic for no fdsys/pkg/FR-2015-09-18/pdf/2015- Furthermore, as specified in § 60.30 (21 more than two days. Subsequent to this 23389.pdf. CFR 60.30), any interested person may approval, the USPTO received patent Docket: For access to the docket to petition FDA for a determination term restoration applications for read background documents or the regarding whether the applicant for RAPIVAB (U.S. Patent Nos. 6,503,745 electronic and written/paper comments extension acted with due diligence and 6,562,861) from BioCryst received, go to https:// during the regulatory review period. To Pharmaceuticals, Inc., and the USPTO www.regulations.gov and insert the meet its burden, the petition must requested FDA’s assistance in docket number, found in brackets in the comply with all the requirements of determining the patents’ eligibility for heading of this document, into the § 60.30, including but not limited to: patent term restoration. In a letter dated ‘‘Search’’ box and follow the prompts Must be timely (see DATES), must be April 29, 2016, FDA advised the USPTO and/or go to the Dockets Management filed in accordance with § 10.20, must that this human drug product had Staff, 5630 Fishers Lane, Rm. 1061, contain sufficient facts to merit an FDA undergone a regulatory review period Rockville, MD 20852. investigation, and must certify that a and that the approval of RAPIVAB true and complete copy of the petition FOR FURTHER INFORMATION CONTACT: represented the first permitted has been served upon the patent Beverly Friedman, Office of Regulatory commercial marketing or use of the applicant. (See H. Rept. 857, part 1, 98th Policy, Food and Drug Administration, product. Thereafter, the USPTO Cong., 2d sess., pp. 41–42, 1984.) 10903 New Hampshire Ave., Bldg. 51, requested that FDA determine the Petitions should be in the format Rm. 6250, Silver Spring, MD 20993, product’s regulatory review period. specified in 21 CFR 10.30. 301–796–3600. II. Determination of Regulatory Review Submit petitions electronically to SUPPLEMENTARY INFORMATION: Period https://www.regulations.gov at Docket I. Background No. FDA–2013–S–0610. Submit written FDA has determined that the petitions (two copies are required) to the The Drug Price Competition and applicable regulatory review period for Dockets Management Staff (HFA–305), Patent Term Restoration Act of 1984 RAPIVAB is 3,287 days. Of this time, Food and Drug Administration, 5630 (Pub. L. 98–417) and the Generic 2,925 days occurred during the testing Fishers Lane, Rm. 1061, Rockville, MD Animal Drug and Patent Term phase of the regulatory review period, 20852. Restoration Act (Pub. L. 100–670) while 362 days occurred during the approval phase. These periods of time Dated: November 22, 2017. generally provide that a patent may be extended for a period of up to 5 years were derived from the following dates: Leslie Kux, so long as the patented item (human 1. The date an exemption under Associate Commissioner for Policy. drug product, animal drug product, section 505(i) of the Federal Food, Drug, [FR Doc. 2017–25676 Filed 11–27–17; 8:45 am] medical device, food additive, or color and Cosmetic Act (the FD&C Act) (21 BILLING CODE 4164–01–P additive) was subject to regulatory U.S.C. 355(i)) became effective: review by FDA before the item was December 21, 2005. FDA has verified marketed. Under these acts, a product’s the BioCryst Pharmaceuticals, Inc. DEPARTMENT OF HEALTH AND regulatory review period forms the basis claims that December 21, 2005, is the HUMAN SERVICES for determining the amount of extension date the investigational new drug application (IND) became effective. Food and Drug Administration an applicant may receive. A regulatory review period consists of 2. The date the application was [Docket No. FDA–2017–N–0001] two periods of time: A testing phase and initially submitted with respect to the an approval phase. For human drug human drug product under section Weighing the Evidence: Variant products, the testing phase begins when 505(b) of the FD&C Act: December 23, Classification and Interpretation in the exemption to permit the clinical 2013. FDA has verified the applicant’s Precision Oncology; Public Workshop ethrower on DSK3G9T082PROD with NOTICES investigations of the drug becomes claims that the new drug application AGENCY: Food and Drug Administration, effective and runs until the approval (NDA) for RAPIVAB (NDA 206426) was HHS. phase begins. The approval phase starts initially submitted on December 23, ACTION: Notice of public workshop. with the initial submission of an 2013. application to market the human drug 3. The date the application was SUMMARY: The Food and Drug product and continues until FDA grants approved: December 19, 2014. FDA has Administration (FDA) is announcing the permission to market the drug product. verified the applicant’s claim that NDA following public workshop entitled VerDate Sep<11>2014 19:51 Nov 27, 2017 Jkt 244001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\28NON1.SGM 28NON1


Document Created: 2017-11-28 01:50:48
Document Modified: 2017-11-28 01:50:48
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 January 29, 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 May 29, 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 Citation82 FR 56244 
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