81 FR 87041 - Determination of Regulatory Review Period for Purposes of Patent Extension; TRUMENBA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 232 (December 2, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 232 (December 2, 2016)
| Page Range | 87041-87042 | |
| FR Document | 2016-28916 |
[Federal Register Volume 81, Number 232 (Friday, December 2, 2016)] [Notices] [Pages 87041-87042] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-28916] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2015-E-3158; FDA-2015-E-3159] Determination of Regulatory Review Period for Purposes of Patent Extension; TRUMENBA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for TRUMENBA 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 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 January 31, 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 May 31, 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-2015-E-3158 and FDA-2015-E-3159 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; TRUMENBA.'' 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 [[Page 87042]] 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 product 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 TRUMENBA (Meningococcal Group B Vaccine). TRUMENBA is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. Meningococcal Group B Vaccine is approved for use in individuals 10 through 25 years of age. Subsequent to this approval, the USPTO received patent term restoration applications for TRUMENBA (U.S. Patent Nos. 8,101,194 and 8,563,007) from Wyeth Holdings LLC, and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated October 19, 2015, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of TRUMENBA 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 TRUMENBA is 2,079 days. Of this time, 1,943 days occurred during the testing phase of the regulatory review period, while 136 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: February 20, 2009. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on February 20, 2009. 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): June 16, 2014. FDA has verified the applicant's claim that the biologics license application (BLA) for TRUMENBA (BLA 125549/0) was initially submitted on June 16, 2014. 3. The date the application was approved: October 29, 2014. FDA has verified the applicant's claim that BLA 125549/0 was approved on October 29, 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 application for patent extension, this applicant seeks 255 days or 573 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 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: November 23, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-28916 Filed 12-1-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 232 / Friday, December 2, 2016 / Notices 87041
Level I and Level II into PACE quality CMS has developed an audit protocol SUPPLEMENTARY INFORMATION section for
data. Additionally, we are establishing and will post it to the CMS Web site more information.
three PACE Quality measures adopted each year for use by POs to prepare for ADDRESSES: You may submit comments
from the National Quality Forum (NQF) their audit. The data collected for audit as follows:
and modified for PACE use. These is detailed in this protocol and the exact
modified PACE quarterly measures are fields are located in the record layouts, Electronic Submissions
Falls, Falls with Injury, and Pressure at the end of the protocol. In addition, Submit electronic comments in the
Injury Prevalence/Prevention. Currently, a questionnaire will be distributed as following way:
the existing Level I and Level II part of our audit. This questionnaire is • Federal eRulemaking Portal:
elements have not been tested for also included in this package. Form https://www.regulations.gov. Follow the
reliability or feasibility. By adopting Number: CMS–10630 (OMB control instructions for submitting comments.
NQF defined reliable data collection number: 0938—New); Frequency: Comments submitted electronically,
process for these elements, certain Yearly; Affected Public: Private sector including attachments, to https://
existing Level I and Level II elements (Business or other for-profits and Not- www.regulations.gov will be posted to
will then officially meet quality for-profits institutions); Number of the docket unchanged. Because your
measures collection standards. These Respondents: 72; Total Annual comment will be made public, you are
measures will be used to improve Responses: 72; Total Annual Hours: solely responsible for ensuring that your
quality of care for participants in PACE. 12,960. (For policy questions regarding comment does not include any
PACE Quality measures will be this collection contact Caroline Zeman confidential information that you or a
implemented via the existing HPMS. at 410–786–0116.) third party may not wish to be posted,
POs will be educated on data criteria, Dated: November 29, 2016. such as medical information, your or
entry and will report quarterly. Form William N. Parham, III, anyone else’s Social Security number, or
Number: CMS–10525 (OMB control confidential business information, such
Director, Paperwork Reduction Staff, Office
number: 0938–1264); Frequency: of Strategic Operations and Regulatory as a manufacturing process. Please note
Quarterly and occasionally; Affected Affairs. that if you include your name, contact
Public: Private sector (Business or other [FR Doc. 2016–29007 Filed 12–1–16; 8:45 am] information, or other information that
for-profits and Not-for-profit identifies you in the body of your
BILLING CODE 4120–01–P
institutions); Number of Respondents: comments, that information will be
100; Total Annual Responses: 29,500; posted on https://www.regulations.gov.
Total Annual Hours: 211,500. (For DEPARTMENT OF HEALTH AND • If you want to submit a comment
policy questions regarding this HUMAN SERVICES with confidential information that you
collection contact Tamika Gladney at do not wish to be made available to the
410–786–0648.) Food and Drug Administration public, submit the comment as a
4. Type of Information Collection written/paper submission and in the
Request: New collection (Request for a [Docket Nos. FDA–2015–E–3158; FDA–
2015–E–3159] manner detailed (see ‘‘Written/Paper
new OMB control number); Title of Submissions’’ and ‘‘Instructions’’).
Information Collection: The PACE Determination of Regulatory Review
Organization (PO) Monitoring and Audit Written/Paper Submissions
Period for Purposes of Patent
Process in 42 CFR part 460; Use: Extension; TRUMENBA Submit written/paper submissions as
Historically, the Programs of All- follows:
Inclusive Care for the Elderly (PACE) AGENCY: Food and Drug Administration, • Mail/Hand delivery/Courier (for
audit protocols have been included in HHS. written/paper submissions): Division of
the Medicare Advantage (MA) and ACTION: Notice. Dockets Management (HFA–305), Food
Medicare Part D audit protocol’s and Drug Administration, 5630 Fishers
information collection request (CMS– SUMMARY: The Food and Drug Lane, Rm. 1061, Rockville, MD 20852.
10191, OMB 0938–1000). However, in Administration (FDA) has determined • For written/paper comments
examining previous submissions, we do the regulatory review period for submitted to the Division of Dockets
not believe that including it with the TRUMENBA and is publishing this Management, FDA will post your
MA and Part D audit protocols allowed notice of that determination as required comment, as well as any attachments,
for an accurate representation of the by law. FDA has made the except for information submitted,
PACE burden. Due to PACE audits being determination because of the marked and identified, as confidential,
substantially different from our MA and submission of an application to the if submitted as detailed in
Part D audits, we have separated the Director of the U.S. Patent and ‘‘Instructions.’’
PACE audit protocols from the MA and Trademark Office (USPTO), Department Instructions: All submissions received
Part D protocols and created this of Commerce, for the extension of a must include the Docket Nos. FDA–
information collection request which patent which claims that human 2015–E–3158 and FDA–2015–E–3159
seeks OMB approval under a new biological product. for ‘‘Determination of Regulatory
control number. DATES: Anyone with knowledge that any Review Period for Purposes of Patent
POs are required to comply with all of the dates as published (see the Extension; TRUMENBA.’’ Received
PACE program requirements. The SUPPLEMENTARY INFORMATION section) are comments will be placed in the docket
growth of these PACE organizations incorrect may submit either electronic and, except for those submitted as
asabaliauskas on DSK3SPTVN1PROD with NOTICES
forced CMS to develop an audit strategy or written comments and ask for a ‘‘Confidential Submissions,’’ publicly
to ensure we continue to obtain redetermination by January 31, 2017. viewable at https://www.regulations.gov
meaningful audit results. As a result, Furthermore, any interested person may or at the Division of Dockets
CMS’ audit strategy reflected a move to petition FDA for a determination Management between 9 a.m. and 4 p.m.,
a more targeted, data-driven and regarding whether the applicant for Monday through Friday.
outcomes-based audit approach. We extension acted with due diligence • Confidential Submissions—To
focused on high-risk areas that have the during the regulatory review period by submit a comment with confidential
greatest potential for participant harm. May 31, 2017. See ‘‘Petitions’’ in the information that you do not wish to be
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![87042 Federal Register / Vol. 81, No. 232 / Friday, December 2, 2016 / Notices
made publicly available, submit your for determining the amount of extension became effective: February 20, 2009.
comments only as a written/paper an applicant may receive. FDA has verified the applicant’s claim
submission. You should submit two A regulatory review period consists of that the date the investigational new
copies total. One copy will include the two periods of time: A testing phase and drug application became effective was
information you claim to be confidential an approval phase. For human on February 20, 2009.
with a heading or cover note that states biological products, the testing phase
begins when the exemption to permit 2. The date the application was
‘‘THIS DOCUMENT CONTAINS
the clinical investigations of the initially submitted with respect to the
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including biological product becomes effective human biological product under section
the claimed confidential information, in and runs until the approval phase 351 of the Public Health Service Act (42
its consideration of comments. The begins. The approval phase starts with U.S.C. 262): June 16, 2014. FDA has
second copy, which will have the the initial submission of an application verified the applicant’s claim that the
claimed confidential information to market the human biological product biologics license application (BLA) for
redacted/blacked out, will be available and continues until FDA grants TRUMENBA (BLA 125549/0) was
for public viewing and posted on permission to market the biological initially submitted on June 16, 2014.
https://www.regulations.gov. Submit product. Although only a portion of a 3. The date the application was
both copies to the Division of Dockets regulatory review period may count approved: October 29, 2014. FDA has
Management. If you do not wish your toward the actual amount of extension verified the applicant’s claim that BLA
name and contact information to be that the Director of USPTO may award
125549/0 was approved on October 29,
made publicly available, you can (for example, half the testing phase must
be subtracted as well as any time that 2014.
provide this information on the cover
sheet and not in the body of your may have occurred before the patent This determination of the regulatory
comments and you must identify this was issued), FDA’s determination of the review period establishes the maximum
information as ‘‘confidential.’’ Any length of a regulatory review period for potential length of a patent extension.
information marked as ‘‘confidential’’ a human biological product will include However, the USPTO applies several
will not be disclosed except in all of the testing phase and approval statutory limitations in its calculations
accordance with 21 CFR 10.20 and other phase as specified in 35 U.S.C. of the actual period for patent extension.
applicable disclosure law. For more 156(g)(1)(B). In its application for patent extension,
information about FDA’s posting of FDA has approved for marketing the this applicant seeks 255 days or 573
comments to public dockets, see 80 FR human biologic product TRUMENBA days of patent term extension.
56469, September 18, 2015, or access (Meningococcal Group B Vaccine).
TRUMENBA is indicated for active III. Petitions
the information at: http://www.fda.gov/
immunization to prevent invasive
regulatoryinformation/dockets/ Anyone with knowledge that any of
disease caused by Neisseria
default.htm. the dates as published are incorrect may
Docket: For access to the docket to meningitidis serogroup B.
Meningococcal Group B Vaccine is submit either electronic or written
read background documents or the comments and ask for a redetermination
approved for use in individuals 10
electronic and written/paper comments (see DATES). Furthermore, any interested
through 25 years of age. Subsequent to
received, go to https://
this approval, the USPTO received person may petition FDA for a
www.regulations.gov and insert the
patent term restoration applications for determination regarding whether the
docket number, found in brackets in the
TRUMENBA (U.S. Patent Nos. 8,101,194 applicant for extension acted with due
heading of this document, into the
and 8,563,007) from Wyeth Holdings diligence during the regulatory review
‘‘Search’’ box and follow the prompts
LLC, and the USPTO requested FDA’s period. To meet its burden, the petition
and/or go to the Division of Dockets
assistance in determining the patents’ must be timely (see DATES) and contain
Management, 5630 Fishers Lane, Rm.
eligibility for patent term restoration. In sufficient facts to merit an FDA
1061, Rockville, MD 20852.
a letter dated October 19, 2015, FDA investigation. (See H. Rept. 857, part 1,
FOR FURTHER INFORMATION CONTACT: advised the USPTO that this human
Beverly Friedman, Office of Regulatory 98th Cong., 2d sess., pp. 41–42, 1984.)
biological product had undergone a Petitions should be in the format
Policy, Food and Drug Administration, regulatory review period and that the
10903 New Hampshire Ave., Bldg. 51, specified in 21 CFR 10.30.
approval of TRUMENBA represented
Rm. 6250, Silver Spring, MD 20993, the first permitted commercial Submit petitions electronically to
301–796–3600. marketing or use of the product. https://www.regulations.gov at Docket
SUPPLEMENTARY INFORMATION: Thereafter, the USPTO requested that No. FDA–2013–S–0610. Submit written
FDA determine the product’s regulatory petitions (two copies are required) to the
I. Background
review period. Division of Dockets Management (HFA–
The Drug Price Competition and 305), Food and Drug Administration,
Patent Term Restoration Act of 1984 II. Determination of Regulatory Review 5630 Fishers Lane, Rm. 1061, Rockville,
(Pub. L. 98–417) and the Generic Period
MD 20852.
Animal Drug and Patent Term FDA has determined that the
Restoration Act (Pub. L. 100–670) Dated: November 23, 2016.
applicable regulatory review period for
generally provide that a patent may be TRUMENBA is 2,079 days. Of this time, Leslie Kux,
asabaliauskas on DSK3SPTVN1PROD with NOTICES
extended for a period of up to 5 years 1,943 days occurred during the testing Associate Commissioner for Policy.
so long as the patented item (human phase of the regulatory review period, [FR Doc. 2016–28916 Filed 12–1–16; 8:45 am]
drug product, animal drug product, while 136 days occurred during the BILLING CODE 4164–01–P
medical device, food additive, or color approval phase. These periods of time
additive) was subject to regulatory were derived from the following dates:
review by FDA before the item was 1. The date an exemption under
marketed. Under these acts, a product’s section 505(i) of the Federal Food, Drug,
regulatory review period forms the basis and Cosmetic Act (21 U.S.C. 355(i))
VerDate Sep<11>2014 17:55 Dec 01, 2016 Jkt 241001 PO 00000 Frm 00026 Fmt 4703 Sfmt 9990 E:\FR\FM\02DEN1.SGM 02DEN1](https://thefederalregister.org/doc/81_FR_87273/page/2.svg)
Document Created: 2018-02-14 09:02:00
Document Modified: 2018-02-14 09:02:00
| 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 January 31, 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 May 31, 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 87041 |
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