81 FR 95618 - Determination of Regulatory Review Period for Purposes of Patent Extension; IMLYGIC
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 249 (December 28, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 249 (December 28, 2016)
| Page Range | 95618-95620 | |
| FR Document | 2016-31322 |
[Federal Register Volume 81, Number 249 (Wednesday, December 28, 2016)] [Notices] [Pages 95618-95620] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-31322] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2016-E-1179; FDA-2016-E-1181; FDA-2016-E-1182] Determination of Regulatory Review Period for Purposes of Patent Extension; IMLYGIC AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for IMLYGIC 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 biological product. DATES: Anyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION section) are [[Page 95619]] incorrect may submit either electronic or written comments and ask for a redetermination by February 27, 2017. 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 June 26, 2017. 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: 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): 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 Nos. FDA-2016-E-1179, FDA-2016-E-1181, and FDA-2016-E-1182 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; IMLYGIC.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://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 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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600. SUPPLEMENTARY INFORMATION: I. Background The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological 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 biologic product IMLYGIC (talimogene laherparepvec). IMLYGIC is indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. Subsequent to this approval, the USPTO received patent term restoration applications for IMLYGIC (U.S. Patent Nos. 7,063,835; 7,223,593; and 7,537,924) from BioVex Limited, and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated July 12, 2016, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of IMLYGIC 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 IMLYGIC is 3,809 days. Of this time, 3,352 days occurred during the testing [[Page 95620]] phase of the regulatory review period, while 457 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: May 25, 2005. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on May 25, 2005. 2. The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C. 262): July 28, 2014. FDA has verified the applicant's claim that the biologics license application (BLA) for IMLYGIC (BLA 125518) was initially submitted on July 28, 2014. 3. The date the application was approved: October 27, 2015. FDA has verified the applicant's claim that BLA 125518 was approved on October 27, 2015. 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 1,826 days, 1,764 days, or 1400 days, respectively, 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 https://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: December 21, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-31322 Filed 12-27-16; 8:45 am] BILLING CODE 4164-01-P
![95618 Federal Register / Vol. 81, No. 249 / Wednesday, December 28, 2016 / Notices
Furthermore, Presidential Policy vulnerabilities with uncontrolled risk. collections of information are subject to
Directive 21—Critical Infrastructure Specifically, FDA does not intend to review by the Office of Management and
Security and Resilience (PPD–21) issued enforce the reporting requirements Budget (OMB) under the Paperwork
on February 12, 2013 tasks Federal when circumstances outlined in the Reduction Act of 1995 (44 U.S.C. 3501–
Government entities to strengthen the guidance are met within the predefined 3520). The collections of information in
security and resilience of critical periods of time (e.g., communicate 21 CFR part 803 (medical device
infrastructure against physical and vulnerability to customers and user reporting) have been approved under
cyber threats such that these efforts community and propose a timeline for OMB control number 0910–0437; the
reduce vulnerabilities, minimize remediation within 30 days after collections of information in 21 CFR
consequences, and identify and disrupt learning of the vulnerability; fix the part 806 (reports of corrections and
threats. PPD–21 encourages all public vulnerability and validate the change removals) have been approved under
and private stakeholders to share within 60 days after learning of the OMB control number 0910–0359; the
responsibility in achieving these vulnerability; actively participate in an collections of information in 21 CFR
outcomes. Information Sharing Analysis part 807, subpart E (premarket
In recognition of the shared Organization (ISAO)). The Agency notification) have been approved under
responsibility for cybersecurity, the considers voluntary participation in an OMB control number 0910–0120; the
security industry has established Information ISAO a critical component collections of information in 21 CFR
resources including standards, of a medical device manufacturer’s part 810 (medical device recall
guidelines, best practices and comprehensive proactive approach to authority) have been approved under
frameworks for stakeholders to adopt a management of postmarket OMB control number 0910–0432; the
culture of cybersecurity risk cybersecurity threats and vulnerabilities collections of information in 21 CFR
management. Best practices include and a significant step towards assuring part 814 (premarket approval) have been
collaboratively assessing cybersecurity the ongoing safety and effectiveness of approved under OMB control number
intelligence information for risks to marketed medical devices. 0910–0231; the collections of
device functionality and clinical risk. information in 21 CFR part 820 (quality
FDA believes that, in alignment with II. Significance of Guidance
system regulations) have been approved
Executive Order 13636 and PPD–21, This guidance is being issued under OMB control number 0910–0073;
public and private stakeholders should consistent with FDA’s good guidance and the collections of information in 21
collaborate to leverage available practices regulation (21 CFR 10.115). CFR part 822 (postmarket surveillance
resources and tools to establish a The guidance represents the current of medical devices) have been approved
common understanding that assesses thinking of FDA on ‘‘Postmarket under OMB control number 0910–0449.
risks for identified vulnerabilities in Management of Cybersecurity in
medical devices among the information Medical Devices.’’ It does not establish Dated: December 22, 2016.
technology community, healthcare any rights for any person and is not Leslie Kux,
delivery organizations, the clinical user binding on FDA or the public. You can Associate Commissioner for Policy.
community, and the medical device use an alternative approach if it satisfies [FR Doc. 2016–31406 Filed 12–27–16; 8:45 am]
community. These collaborations can the requirements of the applicable BILLING CODE 4164–01–P
lead to the consistent assessment and statutes and regulations.
mitigation of cybersecurity threats, and
III. Electronic Access
their impact on medical device safety DEPARTMENT OF HEALTH AND
and effectiveness, ultimately reducing Persons interested in obtaining a copy HUMAN SERVICES
potential risk of patient harm. of the guidance may do so by
Part 806 (21 CFR part 806) requires downloading an electronic copy from Food and Drug Administration
device manufacturers or importers to the Internet. A search capability for all [Docket Nos. FDA–2016–E–1179; FDA–
report promptly to FDA certain actions Center for Devices and Radiological 2016–E–1181; FDA–2016–E–1182]
concerning device corrections and Health guidance documents is available
removals. However, the majority of at http://www.fda.gov/MedicalDevices/ Determination of Regulatory Review
actions taken by manufacturers to DeviceRegulationandGuidance/ Period for Purposes of Patent
address cybersecurity vulnerabilities GuidanceDocuments/default.htm. Extension; IMLYGIC
and exploits, referred to as Guidance documents are also available
‘‘cybersecurity routine updates and at http://www.fda.gov/BiologicsBlood AGENCY: Food and Drug Administration,
patches,’’ are generally considered to be Vaccines/GuidanceCompliance HHS.
a type of device enhancement for which RegulatoryInformation/Guidances/ ACTION: Notice.
the FDA does not require advance default.htm or http://
notification or reporting under part 806. www.regulations.gov. Persons unable to SUMMARY: The Food and Drug
For a small subset of actions taken by download an electronic copy of Administration (FDA) has determined
manufacturers to correct device ‘‘Postmarket Management of the regulatory review period for
cybersecurity vulnerabilities and Cybersecurity in Medical Devices’’ may IMLYGIC and is publishing this notice
exploits that may pose a risk to health, send an email request to CDRH- of that determination as required by
the FDA would require medical device Guidance@fda.hhs.gov to receive an law. FDA has made the determination
manufacturers to notify the Agency. electronic copy of the document. Please because of the submission of
This guidance clarifies changes to applications to the Director of the U.S.
sradovich on DSK3GMQ082PROD with NOTICES
use the document number 1400044 to
devices to be considered cybersecurity identify the guidance you are Patent and Trademark Office (USPTO),
routine updates and patches (e.g., requesting. Department of Commerce, for the
certain actions to maintain a controlled extension of a patent which claims that
risk to health). In addition, the guidance IV. Paperwork Reduction Act of 1995 human biological product.
outlines circumstances in which FDA This guidance refers to previously DATES: Anyone with knowledge that any
does not intend to enforce reporting approved collections of information of the dates as published (see the
requirements under part 806 for specific found in FDA regulations. These SUPPLEMENTARY INFORMATION section) are
VerDate Sep<11>2014 18:54 Dec 27, 2016 Jkt 241001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 E:\FR\FM\28DEN1.SGM 28DEN1](https://thefederalregister.org/doc/81_FR_95867/page/1.svg)
![95620 Federal Register / Vol. 81, No. 249 / Wednesday, December 28, 2016 / Notices
phase of the regulatory review period, DEPARTMENT OF HEALTH AND Dated: December 22, 2016.
while 457 days occurred during the HUMAN SERVICES Leslie Kux,
approval phase. These periods of time Associate Commissioner for Policy.
were derived from the following dates: Food and Drug Administration [FR Doc. 2016–31391 Filed 12–27–16; 8:45 am]
1. The date an exemption under BILLING CODE 4164–01–P
section 505(i) of the Federal Food, Drug, [Docket No. FDA–2010–N–0067]
and Cosmetic Act (21 U.S.C. 355(i))
became effective: May 25, 2005. FDA Pharmaceutical Science and Clinical DEPARTMENT OF HEALTH AND
has verified the applicant’s claim that Pharmacology Advisory Committee; HUMAN SERVICES
the date the investigational new drug Notice of Meeting; Correction
application became effective was on Health Resources and Services
May 25, 2005. AGENCY: Food and Drug Administration, Administration
HHS.
2. The date the application was
ACTION: Notice; correction. Agency Information Collection
initially submitted with respect to the
Activities: Submission to OMB for
human biological product under section
SUMMARY: The Food and Drug Review and Approval; Public Comment
351 of the Public Health Service Act (42
Administration is correcting a notice Request; Evaluation and Assessment
U.S.C. 262): July 28, 2014. FDA has
entitled ‘‘Pharmaceutical Science and of HRSA Teaching Health Centers
verified the applicant’s claim that the
biologics license application (BLA) for Clinical Pharmacology Advisory AGENCY: Health Resources and Services
IMLYGIC (BLA 125518) was initially Committee; Notice of Meeting’’ that Administration (HRSA), Department of
submitted on July 28, 2014. appeared in the Federal Register of Health and Human Services (HHS).
3. The date the application was November 29, 2016 (81 FR 85978). The
ACTION: Notice.
approved: October 27, 2015. FDA has document announced the forthcoming
verified the applicant’s claim that BLA public advisory committee meeting of SUMMARY: In compliance with Section
125518 was approved on October 27, the Pharmaceutical Science and Clinical 3507(a)(1)(D) of the Paperwork
2015. Pharmacology Advisory Committee. The Reduction Act of 1995, HRSA has
This determination of the regulatory document was published with an error submitted an Information Collection
review period establishes the maximum in the DATES section. This document Request (ICR) to the Office of
potential length of a patent extension. corrects that error. Management and Budget (OMB) for
However, the USPTO applies several FOR FURTHER INFORMATION CONTACT: review and approval. Comments
statutory limitations in its calculations Jennifer Shepherd, Center for Drug submitted during the first public review
of the actual period for patent extension. Evaluation and Research, Food and of this ICR will be provided to OMB.
In its applications for patent extension, Drug Administration, 10903 New OMB will accept further comments from
this applicant seeks 1,826 days, 1,764 Hampshire Ave., Bldg. 31, Rm. 2417, the public during the review and
days, or 1400 days, respectively, of Silver Spring, MD 20993–0002, 301– approval period.
patent term extension. 796–9001, FAX: 301–847–8533, email: DATES: Comments on this ICR should be
ACPS-CP@fda.hhs.gov, or FDA received no later than January 27, 2017.
III. Petitions Advisory Committee Information Line, ADDRESSES: Submit your comments,
Anyone with knowledge that any of 1–800–741–8138 (301–443–0572 in the including the ICR Title, to the desk
the dates as published are incorrect may Washington, DC area). A notice in the officer for HRSA, either by email to
submit either electronic or written Federal Register about last minute OIRA_submission@omb.eop.gov or by
comments and ask for a redetermination modifications that impact a previously fax to 202–395–5806.
(see DATES). Furthermore, any interested announced advisory committee meeting
cannot always be published quickly FOR FURTHER INFORMATION CONTACT: To
person may petition FDA for a
determination regarding whether the enough to provide timely notice. request a copy of the clearance requests
applicant for extension acted with due Therefore, you should always check the submitted to OMB for review, email the
diligence during the regulatory review Agency’s Web site at http:// HRSA Information Collection Clearance
period. To meet its burden, the petition www.fda.gov/AdvisoryCommittees/ Officer at paperwork@hrsa.gov or call
must be timely (see DATES) and contain default.htm and scroll down to the (301) 443–1984.
sufficient facts to merit an FDA appropriate advisory committee meeting SUPPLEMENTARY INFORMATION:
investigation. (See H. Rept. 857, part 1, link, or call the advisory committee Information Collection Request Title:
98th Cong., 2d sess., pp. 41–42, 1984.) information line to learn about possible Evaluation and Assessment of HRSA
Petitions should be in the format modifications before coming to the Teaching Health Centers.
specified in 21 CFR 10.30. meeting. OMB No. 0915–0376—Extension.
Submit petitions electronically to Abstract: The Teaching Health Center
SUPPLEMENTARY INFORMATION: Graduate Medical Education (THCGME)
https://www.regulations.gov at Docket
In the Federal Register of Tuesday, program supports new and the
No. FDA–2013–S–0610. Submit written
November 29, 2016, in FR Doc. 2016– expansion of existing primary care
petitions (two copies are required) to the
28723, the following correction is made: residency training programs in
Division of Dockets Management (HFA–
305), Food and Drug Administration, On page 85978, in the third column, community-based settings. The primary
in the DATES section, the following goals of the THCGME program are to
sradovich on DSK3GMQ082PROD with NOTICES
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852. sentence is to be inserted after the first increase the production of primary care
sentence: ‘‘FDA is opening a docket for doctors and dentists who are well
Dated: December 21, 2016. public comment on this meeting. The prepared to practice in community
Leslie Kux, docket number is FDA–2010–N–0067. settings, particularly with underserved
Associate Commissioner for Policy. The docket will open for public populations, and to improve the overall
[FR Doc. 2016–31322 Filed 12–27–16; 8:45 am] comment on December 28, 2016. The number and geographic distribution of
BILLING CODE 4164–01–P docket will close on April 14, 2017.’’ primary care providers.
VerDate Sep<11>2014 18:54 Dec 27, 2016 Jkt 241001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 E:\FR\FM\28DEN1.SGM 28DEN1](https://thefederalregister.org/doc/81_FR_95867/page/3.svg)
Document Created: 2016-12-28 02:16:29
Document Modified: 2016-12-28 02:16:29
| 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 (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by February 27, 2017. 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 June 26, 2017. 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 95618 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR