82 FR 36790 - Determination of Regulatory Review Period for Purposes of Patent Extension; CINQAIR
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 150 (August 7, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 150 (August 7, 2017)
| Page Range | 36790-36792 | |
| FR Document | 2017-16516 |
[Federal Register Volume 82, Number 150 (Monday, August 7, 2017)] [Notices] [Pages 36790-36792] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-16516] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-E-2531] Determination of Regulatory Review Period for Purposes of Patent Extension; CINQAIR AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for CINQAIR 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 (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by October 6, 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 February 5, 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 October 6, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of October 6, 2017. 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''). [[Page 36791]] Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2016-E-2531 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; CINQAIR.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 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 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 CINQAIR (reslizumab). CINQAIR is indicated for add-on maintenance treatment of patients with severe asthma aged 18 years and older, and with an eosinophilic phenotype. Subsequent to this approval, the USPTO received a patent term restoration application for CINQAIR (U.S. Patent No. RE39,548) from UCB Celltech, and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated September 26, 2016, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of CINQAIR 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 CINQAIR is 5,685 days. Of this time, 5,325 days occurred during the testing phase of the regulatory review period, while 360 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: August 31, 2000. The applicant claims February 15, 2008, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was August 31, 2000, which was 30 days after FDA receipt of the first IND. 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): March 30, 2015. FDA has verified the applicant's claim that the biologics license application (BLA) for CINQAIR (BLA 761033) was initially submitted on March 30, 2015. 3. The date the application was approved: March 23, 2016. FDA has verified the applicant's claim that BLA 761033 was approved on March 23, 2016. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,660 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 21 CFR 60.30, any interested person may petition FDA for a determination [[Page 36792]] 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 Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: August 1, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-16516 Filed 8-4-17; 8:45 am] BILLING CODE 4164-01-P
![36790 Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / Notices
Staff, 5630 Fishers Lane, Rm. 1061, statement of the general nature of the submission of an application to the
Rockville, MD 20852. evidence or arguments they wish to Director of the U.S. Patent and
FOR FURTHER INFORMATION CONTACT: present, the names and addresses of Trademark Office (USPTO), Department
Cindy Chee, Center for Drug Evaluation proposed participants, and an of Commerce, for the extension of a
and Research, Food and Drug indication of the approximate time patent which claims that human
Administration, 10903 New Hampshire requested to make their presentation on biological product.
Ave., Bldg. 31, Rm. 2417, Silver Spring, or before August 25, 2017. Time allotted DATES: Anyone with knowledge that any
MD 20993–0002, 301–796–9001, FAX: for each presentation may be limited. If
of the dates as published (in the
301–847–8533, email: ODAC@ the number of registrants requesting to
SUPPLEMENTARY INFORMATION section) are
fda.hhs.gov, or FDA Advisory speak is greater than can be reasonably
incorrect may submit either electronic
Committee Information Line, 1–800– accommodated during the scheduled
or written comments and ask for a
741–8138 (301–443–0572 in the open public hearing session, FDA may
redetermination by October 6, 2017.
Washington, DC area). A notice in the conduct a lottery to determine the
Furthermore, any interested person may
Federal Register about last minute speakers for the scheduled open public
petition FDA for a determination
modifications that impact a previously hearing session. The contact person will
regarding whether the applicant for
announced advisory committee meeting notify interested persons regarding their
extension acted with due diligence
cannot always be published quickly request to speak by August 28, 2017.
during the regulatory review period by
enough to provide timely notice. Persons attending FDA’s advisory
February 5, 2018. See ‘‘Petitions’’ in the
Therefore, you should always check the committee meetings are advised that the
SUPPLEMENTARY INFORMATION section for
Agency’s Web site at https:// Agency is not responsible for providing
more information.
www.fda.gov/AdvisoryCommittees/ access to electrical outlets.
default.htm and scroll down to the FDA welcomes the attendance of the ADDRESSES: You may submit comments
appropriate advisory committee meeting public at its advisory committee as follows. Please note that late,
link, or call the advisory committee meetings and will make every effort to untimely filed comments will not be
information line to learn about possible accommodate persons with disabilities. considered. Electronic comments must
modifications before coming to the If you require special accommodations be submitted on or before October 6,
meeting. due to a disability, please contact Cindy 2017. The https://www.regulations.gov
Chee at least 7 days in advance of the electronic filing system will accept
SUPPLEMENTARY INFORMATION: Agenda:
meeting. comments until midnight Eastern Time
The committee will discuss FDA is committed to the orderly at the end of October 6, 2017. Comments
supplemental new drug application conduct of its advisory committee received by mail/hand delivery/courier
(sNDA) 021938/033 SUTENT (sunitinib meetings. Please visit our Web site at (for written/paper submissions) will be
malate) oral capsules, submitted by C.P. https://www.fda.gov/Advisory considered timely if they are
Pharmaceuticals International C.V., Committees/AboutAdvisoryCommittees/ postmarked or the delivery service
represented by Pfizer, Inc. (authorized ucm111462.htm for procedures on acceptance receipt is on or before that
U.S. agent). The proposed indication public conduct during advisory date.
(use) for this product is for the adjuvant committee meetings.
treatment of adult patients at high risk Notice of this meeting is given under Electronic Submissions
of recurrent renal cell carcinoma the Federal Advisory Committee Act (5 Submit electronic comments in the
following nephrectomy. U.S.C. app. 2).
FDA intends to make background following way:
material available to the public no later Dated: August 1, 2017. • Federal eRulemaking Portal:
than 2 business days before the meeting. Anna K. Abram, https://www.regulations.gov. Follow the
If FDA is unable to post the background Deputy Commissioner for Policy, Planning, instructions for submitting comments.
material on its Web site prior to the Legislation, and Analysis. Comments submitted electronically,
meeting, the background material will [FR Doc. 2017–16518 Filed 8–4–17; 8:45 am] including attachments, to https://
be made publicly available at the BILLING CODE 4164–01–P www.regulations.gov will be posted to
location of the advisory committee the docket unchanged. Because your
meeting, and the background material comment will be made public, you are
will be posted on FDA’s Web site after DEPARTMENT OF HEALTH AND solely responsible for ensuring that your
the meeting. Background material is HUMAN SERVICES comment does not include any
available at https://www.fda.gov/ confidential information that you or a
Food and Drug Administration third party may not wish to be posted,
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the [Docket No. FDA–2016–E–2531] such as medical information, your or
appropriate advisory committee meeting anyone else’s Social Security number, or
link. Determination of Regulatory Review confidential business information, such
Procedure: Interested persons may Period for Purposes of Patent as a manufacturing process. Please note
present data, information, or views, Extension; CINQAIR that if you include your name, contact
orally or in writing, on issues pending AGENCY: Food and Drug Administration, information, or other information that
before the committee. All electronic and HHS. identifies you in the body of your
written submissions submitted to the comments, that information will be
ACTION: Notice. posted on https://www.regulations.gov.
docket (see ADDRESSES) on or before
mstockstill on DSK30JT082PROD with NOTICES
September 5, 2017, will be provided to SUMMARY: The Food and Drug • If you want to submit a comment
the committee. Oral presentations from Administration (FDA or the Agency) has with confidential information that you
the public will be scheduled between determined the regulatory review period do not wish to be made available to the
approximately 11 a.m. and noon. Those for CINQAIR and is publishing this public, submit the comment as a
individuals interested in making formal notice of that determination as required written/paper submission and in the
oral presentations should notify the by law. FDA has made the manner detailed (see ‘‘Written/Paper
contact person and submit a brief determination because of the Submissions’’ and ‘‘Instructions’’).
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![36792 Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / Notices
regarding whether the applicant for including each proposed extension of an drug applications (ANDAs). In the
extension acted with due diligence existing collection of information, and Federal Register of June 11, 2010, FDA
during the regulatory review period. To to allow 60 days for public comment in announced the availability of a guidance
meet its burden, the petition must be response to the notice. for industry entitled ‘‘Bioequivalence
timely (see DATES) and contain sufficient In the March 15, 2017, Federal Recommendations for Specific
facts to merit an FDA investigation. (See Register notice, FDA proposed to extend Products’’ that explained the process
H. Rept. 857, part 1, 98th Cong., 2d the information collection related to that would be used to make product-
sess., pp. 41–42, 1984.) Petitions should SACs (OMB control number 0910– specific BE recommendations available
be in the format specified in 21 CFR 0766). However, we are withdrawing the to the public on FDA’s Web site. The
10.30. notice because, upon further review of product-specific guidances identified in
Submit petitions electronically to the information collection request (ICR) this notice were developed using the
http://www.regulations.gov at Docket associated with the notice and process described in that guidance.
No. FDA–2013–S–0610. Submit written comments received on the information DATES: Submit either electronic or
petitions (two copies are required) to the collection, we have determined that the written comments on Agency guidances
Dockets Management Staff (HFA–305), estimated burden expressed in the SAC at any time.
Food and Drug Administration, 5630 ICR is included as part of the estimated
burden for the information collections ADDRESSES: You may submit comments
Fishers Lane, Rm. 1061, Rockville, MD
in the premarket notification (510(k)) as follows:
20852.
ICR (OMB control number 0910–0120). Electronic Submissions
Dated: August 1, 2017.
Because the information collected for
Anna K. Abram, safety assurance cases is already Submit electronic comments in the
Deputy Commissioner for Policy, Planning, included under another information following way:
Legislation, and Analysis. collection approval, we have • Federal eRulemaking Portal:
[FR Doc. 2017–16516 Filed 8–4–17; 8:45 am] discontinued the ICR and we are https://www.regulations.gov. Follow the
BILLING CODE 4164–01–P withdrawing the March 15, 2017, notice instructions for submitting comments.
requesting comment on the information Comments submitted electronically,
collection. including attachments, to https://
DEPARTMENT OF HEALTH AND The guidance entitled ‘‘Infusion www.regulations.gov will be posted to
HUMAN SERVICES Pumps Total Product Life Cycle; the docket unchanged. Because your
Guidance for Industry and FDA Staff’’ comment will be made public, you are
Food and Drug Administration (https://www.fda.gov/ucm/groups/ solely responsible for ensuring that your
[Docket No. FDA–2017–N–0041] fdagov-public/@fdagov-meddev-gen/ comment does not include any
documents/document/ucm209337.pdf), confidential information that you or a
Agency Information Collection which provides recommendations on third party may not wish to be posted,
Activities; Proposed Collection; the inclusion of safety assurance cases such as medical information, your or
Comment Request; Safety Assurance as part of the premarket submissions for anyone else’s Social Security number, or
Case; Withdrawal of Notice new, changed, or modified infusion confidential business information, such
pumps submitted by device as a manufacturing process. Please note
AGENCY: Food and Drug Administration, that if you include your name, contact
HHS. manufacturers, continues to provide the
Agency’s current thinking on this topic. information, or other information that
ACTION: Notice; withdrawal. identifies you in the body of your
Dated: August 2, 2017.
SUMMARY: The Food and Drug comments, that information will be
Anna K. Abram, posted on https://www.regulations.gov.
Administration (FDA) is announcing the
withdrawal of a notice that was
Deputy Commissioner for Policy, Planning, • If you want to submit a comment
Legislation, and Analysis. with confidential information that you
published in the Federal Register of [FR Doc. 2017–16561 Filed 8–4–17; 8:45 am]
March 15, 2017. do not wish to be made available to the
BILLING CODE 4164–01–P public, submit the comment as a
DATES: August 7, 2017.
written/paper submission and in the
FOR FURTHER INFORMATION CONTACT: manner detailed (see ‘‘Written/Paper
Amber Sanford, Office of Operations, DEPARTMENT OF HEALTH AND Submissions’’ and ‘‘Instructions’’).
Food and Drug Administration, Three HUMAN SERVICES
White Flint North, 10A63, 11601 Written/Paper Submissions
Landsdown St., North Bethesda, MD Food and Drug Administration
Submit written/paper submissions as
20852, 301–796–8867, PRAStaff@ [Docket No. FDA–2007–D–0369] follows:
fda.hhs.gov. • Mail/Hand delivery/Courier (for
SUPPLEMENTARY INFORMATION: In a notice Product-Specific Guidances; Final written/paper submissions): Dockets
published in the Federal Register of Guidances for Industry; Availability Management Staff (HFA–305), Food and
March 15, 2017 (82 FR 13817), ‘‘Agency AGENCY: Food and Drug Administration, Drug Administration, 5630 Fishers
Information Collection Activities; HHS. Lane, Rm. 1061, Rockville, MD 20852.
Proposed Collection; Comment Request; ACTION: Notice of availability. • For written/paper comments
Safety Assurance Case,’’ FDA requested submitted to the Dockets Management
comment on the information collection SUMMARY: The Food and Drug Staff, FDA will post your comment, as
mstockstill on DSK30JT082PROD with NOTICES
associated with safety assurance cases Administration (FDA or Agency) is well as any attachments, except for
(SACs). announcing the availability of final information submitted, marked and
Under the Paperwork Reduction Act product-specific guidances. The identified, as confidential, if submitted
of 1995 (PRA), Federal Agencies are guidances provide product-specific as detailed in ‘‘Instructions.’’
required to publish notice in the recommendations on, among other Instructions: All submissions received
Federal Register concerning each things, the design of bioequivalence must include the Docket No. FDA–
proposed collection of information, (BE) studies to support abbreviated new 2007–D–0369 for ‘‘Product-Specific
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Document Created: 2017-08-05 03:00:15
Document Modified: 2017-08-05 03:00:15
| 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 (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by October 6, 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 February 5, 2018. 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 | 82 FR 36790 |
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