81 FR 72062 - Determination of Regulatory Review Period for Purposes of Patent Extension; PLEGRIDY
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 202 (October 19, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 202 (October 19, 2016)
| Page Range | 72062-72063 | |
| FR Document | 2016-25222 |
[Federal Register Volume 81, Number 202 (Wednesday, October 19, 2016)] [Notices] [Pages 72062-72063] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-25222] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2015-E-2780; FDA-2015-E-2778; FDA-2015-E-2779] Determination of Regulatory Review Period for Purposes of Patent Extension; PLEGRIDY AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for PLEGRIDY 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 incorrect may submit either electronic or written comments and ask for a redetermination by December 19, 2016. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by April 17, 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: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket Nos. FDA-2015-E-2780; FDA-2015-E-2778; and FDA-2015-E-2779 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; PLEGRIDY.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600. SUPPLEMENTARY INFORMATION: I. Background The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis [[Page 72063]] 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 PLEGRIDY (peginterferon beta-1a). PLEGRIDY is indicated for treatment of patients with relapsing forms of multiple sclerosis. Subsequent to this approval, the USPTO received patent term restoration applications for PLEGRIDY (U.S. Patent Nos. 7,446,173; 8,017,733; and 8,524,660) from Biogen Idec MA Inc., and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated October 15, 2015, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of PLEGRIDY 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 PLEGRIDY is 2,643 days. Of this time, 2,186 days occurred during the testing 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 23, 2007. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on May 23, 2007. 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): May 16, 2013. FDA has verified the applicant's claim that the biologics license application (BLA) for PLEGRIDY (BLA 125499) was initially submitted on May 16, 2013. 3. The date the application was approved: August 15, 2014. FDA has verified the applicant's claim that BLA 125499 was approved on August 15, 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 1,284 days, 762 days, or 346 days of patent term extension, respectively. III. Petitions Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and ask for a redetermination (see DATES). Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must be timely (see DATES) and contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Submit petitions electronically to http://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: October 13, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-25222 Filed 10-18-16; 8:45 am] BILLING CODE 4164-01-P
![72062 Federal Register / Vol. 81, No. 202 / Wednesday, October 19, 2016 / Notices
comments and ask for a redetermination ADDRESSES: You may submit comments comments only as a written/paper
(see DATES). Furthermore, any interested as follows: submission. You should submit two
person may petition FDA for a copies total. One copy will include the
Electronic Submissions
determination regarding whether the information you claim to be confidential
applicant for extension acted with due Submit electronic comments in the with a heading or cover note that states
diligence during the regulatory review following way: ‘‘THIS DOCUMENT CONTAINS
period. To meet its burden, the petition • Federal eRulemaking Portal: http:// CONFIDENTIAL INFORMATION.’’ The
must be timely (see DATES) and contain www.regulations.gov. Follow the Agency will review this copy, including
sufficient facts to merit an FDA instructions for submitting comments. the claimed confidential information, in
investigation. (See H. Rept. 857, part 1, Comments submitted electronically, its consideration of comments. The
98th Cong., 2d sess., pp. 41–42, 1984.) including attachments, to http:// second copy, which will have the
Petitions should be in the format www.regulations.gov will be posted to claimed confidential information
specified in 21 CFR 10.30. the docket unchanged. Because your redacted/blacked out, will be available
Submit petitions electronically to comment will be made public, you are for public viewing and posted on http://
http://www.regulations.gov at Docket solely responsible for ensuring that your www.regulations.gov. Submit both
No. FDA–2013–S–0610. Submit written comment does not include any copies to the Division of Dockets
petitions (two copies are required) to the confidential information that you or a Management. If you do not wish your
Division of Dockets Management (HFA– third party may not wish to be posted, name and contact information to be
305), Food and Drug Administration, such as medical information, your or made publicly available, you can
5630 Fishers Lane, Rm. 1061, Rockville, anyone else’s Social Security number, or provide this information on the cover
MD 20852. confidential business information, such sheet and not in the body of your
Dated: October 13, 2016. as a manufacturing process. Please note comments and you must identify this
Leslie Kux, that if you include your name, contact information as ‘‘confidential.’’ Any
Associate Commissioner for Policy.
information, or other information that information marked as ‘‘confidential’’
identifies you in the body of your will not be disclosed except in
[FR Doc. 2016–25220 Filed 10–18–16; 8:45 am]
comments, that information will be accordance with 21 CFR 10.20 and other
BILLING CODE 4164–01–P
posted on http://www.regulations.gov. applicable disclosure law. For more
• If you want to submit a comment information about FDA’s posting of
with confidential information that you comments to public dockets, see 80 FR
DEPARTMENT OF HEALTH AND
do not wish to be made available to the 56469, September 18, 2015, or access
HUMAN SERVICES
public, submit the comment as a the information at: http://www.fda.gov/
Food and Drug Administration written/paper submission and in the regulatoryinformation/dockets/
manner detailed (see ‘‘Written/Paper default.htm.
[Docket Nos. FDA–2015–E–2780; FDA– Submissions’’ and ‘‘Instructions’’).
2015–E–2778; FDA–2015–E–2779] Docket: For access to the docket to
Written/Paper Submissions read background documents or the
Determination of Regulatory Review Submit written/paper submissions as electronic and written/paper comments
Period for Purposes of Patent received, go to http://
follows:
Extension; PLEGRIDY • Mail/Hand delivery/Courier (for www.regulations.gov and insert the
AGENCY: Food and Drug Administration, written/paper submissions): Division of docket number, found in brackets in the
HHS. Dockets Management (HFA–305), Food heading of this document, into the
ACTION: Notice. and Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Division of Dockets
SUMMARY: The Food and Drug • For written/paper comments Management, 5630 Fishers Lane, Rm.
Administration (FDA) has determined submitted to the Division of Dockets 1061, Rockville, MD 20852.
the regulatory review period for Management, FDA will post your FOR FURTHER INFORMATION CONTACT:
PLEGRIDY and is publishing this notice comment, as well as any attachments, Beverly Friedman, Office of Regulatory
of that determination as required by except for information submitted, Policy, Food and Drug Administration,
law. FDA has made the determination marked and identified, as confidential, 10903 New Hampshire Ave., Bldg. 51,
because of the submission of if submitted as detailed in Rm. 6250, Silver Spring, MD 20993,
applications to the Director of the U.S. ‘‘Instructions.’’ 301–796–3600.
Patent and Trademark Office (USPTO), Instructions: All submissions received
Department of Commerce, for the must include the Docket Nos. FDA– SUPPLEMENTARY INFORMATION:
extension of a patent which claims that 2015–E–2780; FDA–2015–E–2778; and I. Background
human biological product. FDA–2015–E–2779 for ‘‘Determination
DATES: Anyone with knowledge that any of Regulatory Review Period for The Drug Price Competition and
of the dates as published (see the Purposes of Patent Extension; Patent Term Restoration Act of 1984
SUPPLEMENTARY INFORMATION section) are PLEGRIDY.’’ Received comments will (Pub. L. 98–417) and the Generic
incorrect may submit either electronic be placed in the docket and, except for Animal Drug and Patent Term
or written comments and ask for a those submitted as ‘‘Confidential Restoration Act (Pub. L. 100–670)
redetermination by December 19, 2016. Submissions,’’ publicly viewable at generally provide that a patent may be
Furthermore, any interested person may extended for a period of up to 5 years
sradovich on DSK3GMQ082PROD with NOTICES
http://www.regulations.gov or at the
petition FDA for a determination Division of Dockets Management so long as the patented item (human
regarding whether the applicant for between 9 a.m. and 4 p.m., Monday drug product, animal drug product,
extension acted with due diligence through Friday. medical device, food additive, or color
during the regulatory review period by • Confidential Submissions—To additive) was subject to regulatory
April 17, 2017. See ‘‘Petitions’’ in the submit a comment with confidential review by FDA before the item was
SUPPLEMENTARY INFORMATION section for information that you do not wish to be marketed. Under these acts, a product’s
more information. made publicly available, submit your regulatory review period forms the basis
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![Federal Register / Vol. 81, No. 202 / Wednesday, October 19, 2016 / Notices 72063
for determining the amount of extension 2. The date the application was DEPARTMENT OF HEALTH AND
an applicant may receive. initially submitted with respect to the HUMAN SERVICES
A regulatory review period consists of human biological product under section
two periods of time: A testing phase and 351 of the Public Health Service Act (42 Food and Drug Administration
an approval phase. For human U.S.C. 262): May 16, 2013. FDA has
biological products, the testing phase [Docket No. FDA–2013–N–0825]
verified the applicant’s claim that the
begins when the exemption to permit biologics license application (BLA) for Agency Information Collection
the clinical investigations of the PLEGRIDY (BLA 125499) was initially Activities; Proposed Collection;
biological becomes effective and runs
submitted on May 16, 2013. Comment Request; Premarket
until the approval phase begins. The
3. The date the application was Approval of Medical Devices
approval phase starts with the initial
submission of an application to market approved: August 15, 2014. FDA has AGENCY: Food and Drug Administration,
the human biological product and verified the applicant’s claim that BLA HHS.
continues until FDA grants permission 125499 was approved on August 15, ACTION: Notice.
to market the biological product. 2014.
Although only a portion of a regulatory This determination of the regulatory SUMMARY: The Food and Drug
review period may count toward the review period establishes the maximum Administration (FDA) is announcing an
actual amount of extension that the potential length of a patent extension. opportunity for public comment on the
Director of USPTO may award (for proposed collection of certain
However, the USPTO applies several
example, half the testing phase must be information by the Agency. Under the
subtracted as well as any time that may statutory limitations in its calculations
of the actual period for patent extension. Paperwork Reduction Act of 1995 (the
have occurred before the patent was PRA), Federal Agencies are required to
issued), FDA’s determination of the In its applications for patent extension,
publish notice in the Federal Register
length of a regulatory review period for this applicant seeks 1,284 days, 762
concerning each proposed collection of
a human biological product will include days, or 346 days of patent term
information, including each proposed
all of the testing phase and approval extension, respectively. extension of an existing collection of
phase as specified in 35 U.S.C. III. Petitions information, and to allow 60 days for
156(g)(1)(B). public comment in response to the
FDA has approved for marketing the Anyone with knowledge that any of notice. This notice solicits comments on
human biologic product PLEGRIDY the dates as published are incorrect may requirements for premarket approval of
(peginterferon beta–1a). PLEGRIDY is submit either electronic or written medical devices.
indicated for treatment of patients with comments and ask for a redetermination DATES: Submit either electronic or
relapsing forms of multiple sclerosis. (see DATES). Furthermore, any interested
Subsequent to this approval, the USPTO written comments on the collection of
person may petition FDA for a information by December 19, 2016.
received patent term restoration
determination regarding whether the ADDRESSES: You may submit comments
applications for PLEGRIDY (U.S. Patent
Nos. 7,446,173; 8,017,733; and applicant for extension acted with due as follows:
8,524,660) from Biogen Idec MA Inc., diligence during the regulatory review
period. To meet its burden, the petition Electronic Submissions
and the USPTO requested FDA’s
assistance in determining the patents’ must be timely (see DATES) and contain Submit electronic comments in the
eligibility for patent term restoration. In sufficient facts to merit an FDA following way:
a letter dated October 15, 2015, FDA investigation. (See H. Rept. 857, part 1, • Federal eRulemaking Portal: http://
advised the USPTO that this human 98th Cong., 2d sess., pp. 41–42, 1984.) www.regulations.gov. Follow the
biological product had undergone a Petitions should be in the format instructions for submitting comments.
regulatory review period and that the specified in 21 CFR 10.30. Comments submitted electronically,
approval of PLEGRIDY represented the including attachments, to http://
Submit petitions electronically to
first permitted commercial marketing or www.regulations.gov will be posted to
http://www.regulations.gov at Docket
use of the product. Thereafter, the the docket unchanged. Because your
No. FDA–2013–S–0610. Submit written comment will be made public, you are
USPTO requested that FDA determine petitions (two copies are required) to the
the product’s regulatory review period. solely responsible for ensuring that your
Division of Dockets Management (HFA– comment does not include any
II. Determination of Regulatory Review 305), Food and Drug Administration, confidential information that you or a
Period 5630 Fishers Lane, Rm. 1061, Rockville, third party may not wish to be posted,
FDA has determined that the MD 20852. such as medical information, your or
applicable regulatory review period for Dated: October 13, 2016. anyone else’s Social Security number, or
PLEGRIDY is 2,643 days. Of this time, Leslie Kux, confidential business information, such
2,186 days occurred during the testing as a manufacturing process. Please note
Associate Commissioner for Policy.
phase of the regulatory review period, that if you include your name, contact
[FR Doc. 2016–25222 Filed 10–18–16; 8:45 am]
while 457 days occurred during the information, or other information that
approval phase. These periods of time BILLING CODE 4164–01–P identifies you in the body of your
were derived from the following dates: comments, that information will be
1. The date an exemption under posted on http://www.regulations.gov.
sradovich on DSK3GMQ082PROD with NOTICES
section 505(i) of the Federal Food, Drug, • If you want to submit a comment
and Cosmetic Act (21 U.S.C. 355(i)) with confidential information that you
became effective: May 23, 2007. FDA do not wish to be made available to the
has verified the applicant’s claim that public, submit the comment as a
the date the investigational new drug written/paper submission and in the
application became effective was on manner detailed (see ‘‘Written/Paper
May 23, 2007. Submissions’’ and ‘‘Instructions’’).
VerDate Sep<11>2014 17:39 Oct 18, 2016 Jkt 241001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\FR\FM\19OCN1.SGM 19OCN1](https://thefederalregister.org/doc/81_FR_72264/page/2.svg)
Document Created: 2016-10-19 02:11:43
Document Modified: 2016-10-19 02:11:43
| 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 December 19, 2016. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by April 17, 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 72062 |
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