83 FR 52839 - Determination of Regulatory Review Period for Purposes of Patent Extension; AFSTYLA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 202 (October 18, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 202 (October 18, 2018)
| Page Range | 52839-52840 | |
| FR Document | 2018-22696 |
[Federal Register Volume 83, Number 202 (Thursday, October 18, 2018)] [Notices] [Pages 52839-52840] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-22696] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-E-3918] Determination of Regulatory Review Period for Purposes of Patent Extension; AFSTYLA 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 AFSTYLA 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 December 17, 2018. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by April 16, 2019. 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 December 17, 2018. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of December 17, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2016-E-3918 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; AFSTYLA.'' 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 Sec. 10.20 (21 CFR 10.20) and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600. SUPPLEMENTARY INFORMATION: I. Background The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human 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 [[Page 52840]] 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 AFSTYLA (Antihemophilic Factor (Recombinant), Single Chain). AFSTYLA is indicated in children and adults with hemophilia A (congenital Factor VIII deficiency) for: (1) On-demand treatment and control of bleeding episodes, (2) routine prophylaxis to reduce the frequency of bleeding episodes, and (3) perioperative management of bleeding. Subsequent to this approval, the USPTO received a patent term restoration application for AFSTYLA (U.S. Patent No. 7,041,635) from SK Chemicals Co, LTD., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated August 1, 2017, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of AFSTYLA 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 AFSTYLA is 1,734 days. Of this time, 1,371 days occurred during the testing phase of the regulatory review period, while 363 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 28, 2011. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on August 28, 2011. 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 29, 2015. FDA has verified the applicant's claim that the biologics license application (BLA) for AFSTYLA (BLA 125591) was initially submitted on May 29, 2015. 3. The date the application was approved: May 25, 2016. FDA has verified the applicant's claim that BLA 125591 was approved on May 25, 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 1,047 days of patent term extension. III. Petitions Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in Sec. 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of Sec. 60.30, including but not limited to: Must be timely (see DATES), must be filed in accordance with Sec. 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: October 12, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-22696 Filed 10-17-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 202 / Thursday, October 18, 2018 / Notices 52839
Dated: October 12, 2018. instructions for submitting comments. its consideration of comments. The
Leslie Kux, Comments submitted electronically, second copy, which will have the
Associate Commissioner for Policy. including attachments, to https:// claimed confidential information
[FR Doc. 2018–22699 Filed 10–17–18; 8:45 am] www.regulations.gov will be posted to redacted/blacked out, will be available
BILLING CODE 4164–01–P the docket unchanged. Because your for public viewing and posted on
comment will be made public, you are https://www.regulations.gov. Submit
solely responsible for ensuring that your both copies to the Dockets Management
DEPARTMENT OF HEALTH AND comment does not include any Staff. If you do not wish your name and
HUMAN SERVICES confidential information that you or a contact information to be made publicly
third party may not wish to be posted, available, you can provide this
Food and Drug Administration such as medical information, your or information on the cover sheet and not
[Docket No. FDA–2016–E–3918] anyone else’s Social Security number, or in the body of your comments and you
confidential business information, such must identify this information as
Determination of Regulatory Review as a manufacturing process. Please note ‘‘confidential.’’ Any information marked
Period for Purposes of Patent that if you include your name, contact as ‘‘confidential’’ will not be disclosed
Extension; AFSTYLA information, or other information that except in accordance with § 10.20 (21
identifies you in the body of your CFR 10.20) and other applicable
AGENCY: Food and Drug Administration, comments, that information will be disclosure law. For more information
HHS. posted on https://www.regulations.gov. about FDA’s posting of comments to
ACTION: Notice. • If you want to submit a comment public dockets, see 80 FR 56469,
with confidential information that you September 18, 2015, or access the
SUMMARY: The Food and Drug do not wish to be made available to the
Administration (FDA or the Agency) has information at: https://www.gpo.gov/
public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015-
determined the regulatory review period
written/paper submission and in the 23389.pdf.
for AFSTYLA and is publishing this
manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
notice of that determination as required
Submissions’’ and ‘‘Instructions’’). read background documents or the
by law. FDA has made the
determination because of the Written/Paper Submissions electronic and written/paper comments
submission of an application to the received, go to https://
Submit written/paper submissions as
Director of the U.S. Patent and www.regulations.gov and insert the
follows:
docket number, found in brackets in the
Trademark Office (USPTO), Department • Mail/Hand delivery/Courier (for
of Commerce, for the extension of a heading of this document, into the
written/paper submissions): Dockets
patent which claims that human ‘‘Search’’ box and follow the prompts
Management Staff (HFA–305), Food and
biological product. and/or go to the Dockets Management
Drug Administration, 5630 Fishers
DATES: Anyone with knowledge that any
Staff, 5630 Fishers Lane, Rm. 1061,
Lane, Rm. 1061, Rockville, MD 20852.
of the dates as published (see the • For written/paper comments Rockville, MD 20852.
SUPPLEMENTARY INFORMATION section) are submitted to the Dockets Management FOR FURTHER INFORMATION CONTACT:
incorrect may submit either electronic Staff, FDA will post your comment, as Beverly Friedman, Office of Regulatory
or written comments and ask for a well as any attachments, except for Policy, Food and Drug Administration,
redetermination by December 17, 2018. information submitted, marked and 10903 New Hampshire Ave., Bldg. 51,
Furthermore, any interested person may identified, as confidential, if submitted Rm. 6250, Silver Spring, MD 20993,
petition FDA for a determination as detailed in ‘‘Instructions.’’ 301–796–3600.
regarding whether the applicant for Instructions: All submissions received SUPPLEMENTARY INFORMATION:
extension acted with due diligence must include the Docket No. FDA–
2016–E–3918 for ‘‘Determination of I. Background
during the regulatory review period by
April 16, 2019. See ‘‘Petitions’’ in the Regulatory Review Period for Purposes The Drug Price Competition and
SUPPLEMENTARY INFORMATION section for of Patent Extension; AFSTYLA.’’ Patent Term Restoration Act of 1984
more information. Received comments, those filed in a (Pub. L. 98–417) and the Generic
ADDRESSES: You may submit comments timely manner (see ADDRESSES), will be Animal Drug and Patent Term
as follows. Please note that late, placed in the docket and, except for Restoration Act (Pub. L. 100–670)
untimely filed comments will not be those submitted as ‘‘Confidential generally provide that a patent may be
considered. Electronic comments must Submissions,’’ publicly viewable at extended for a period of up to 5 years
be submitted on or before December 17, https://www.regulations.gov or at the so long as the patented item (human
2018. The https://www.regulations.gov Dockets Management Staff between 9 drug product, animal drug product,
electronic filing system will accept a.m. and 4 p.m., Monday through medical device, food additive, or color
comments until 11:59 p.m. Eastern Time Friday. additive) was subject to regulatory
at the end of December 17, 2018. • Confidential Submissions—To review by FDA before the item was
Comments received by mail/hand submit a comment with confidential marketed. Under these acts, a product’s
delivery/courier (for written/paper information that you do not wish to be regulatory review period forms the basis
submissions) will be considered timely made publicly available, submit your for determining the amount of extension
if they are postmarked or the delivery comments only as a written/paper an applicant may receive.
submission. You should submit two A regulatory review period consists of
khammond on DSK30JT082PROD with NOTICES
service acceptance receipt is on or
before that date. copies total. One copy will include the two periods of time: A testing phase and
information you claim to be confidential an approval phase. For human
Electronic Submissions with a heading or cover note that states biological products, the testing phase
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS begins when the exemption to permit
following way: CONFIDENTIAL INFORMATION.’’ The the clinical investigations of the
• Federal eRulemaking Portal: Agency will review this copy, including biological product becomes effective
https://www.regulations.gov. Follow the the claimed confidential information, in and runs until the approval phase
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![52840 Federal Register / Vol. 83, No. 202 / Thursday, October 18, 2018 / Notices
begins. The approval phase starts with verified the applicant’s claim that the DEPARTMENT OF HEALTH AND
the initial submission of an application biologics license application (BLA) for HUMAN SERVICES
to market the human biological product AFSTYLA (BLA 125591) was initially
and continues until FDA grants submitted on May 29, 2015. Health Resources and Services
permission to market the biological Administration
3. The date the application was
product. Although only a portion of a
approved: May 25, 2016. FDA has Agency Information Collection
regulatory review period may count
toward the actual amount of extension verified the applicant’s claim that BLA Activities: Proposed Collection: Public
that the Director of USPTO may award 125591 was approved on May 25, 2016. Comment Request: Information
(for example, half the testing phase must This determination of the regulatory Collection Request Title: Bureau of
be subtracted as well as any time that review period establishes the maximum Health Workforce Performance Data
may have occurred before the patent potential length of a patent extension. Collection, OMB No. 0915–0061—
was issued), FDA’s determination of the However, the USPTO applies several Revision
length of a regulatory review period for statutory limitations in its calculations AGENCY: Health Resources and Services
a human biological product will include of the actual period for patent extension. Administration (HRSA), Department of
all of the testing phase and approval In its application for patent extension, Health and Human Services (HHS).
phase as specified in 35 U.S.C. this applicant seeks 1,047 days of patent
156(g)(1)(B). ACTION: Notice.
term extension.
FDA has approved for marketing the
SUMMARY: In compliance with the
human biologic product AFSTYLA III. Petitions requirement for opportunity for public
(Antihemophilic Factor (Recombinant),
Anyone with knowledge that any of comment on proposed data collection
Single Chain). AFSTYLA is indicated in
the dates as published are incorrect may projects of the Paperwork Reduction Act
children and adults with hemophilia A
submit either electronic or written of 1995, HRSA announces plans to
(congenital Factor VIII deficiency) for:
comments and, under 21 CFR 60.24, ask submit an Information Collection
(1) On-demand treatment and control of
Request (ICR), described below, to the
bleeding episodes, (2) routine for a redetermination (see DATES).
Office of Management and Budget
prophylaxis to reduce the frequency of Furthermore, as specified in § 60.30 (21
(OMB). Prior to submitting the ICR to
bleeding episodes, and (3) perioperative CFR 60.30), any interested person may
OMB, HRSA seeks comments from the
management of bleeding. Subsequent to petition FDA for a determination
this approval, the USPTO received a public regarding the burden estimate,
regarding whether the applicant for below, or any other aspect of the ICR.
patent term restoration application for extension acted with due diligence
AFSTYLA (U.S. Patent No. 7,041,635) DATES: Comments on this ICR should be
during the regulatory review period. To
from SK Chemicals Co, LTD., and the received no later than December 17,
meet its burden, the petition must
USPTO requested FDA’s assistance in 2018.
comply with all the requirements of
determining this patent’s eligibility for § 60.30, including but not limited to: ADDRESSES: Submit your comments to
patent term restoration. In a letter dated paperwork@hrsa.gov or mail the HRSA
Must be timely (see DATES), must be
August 1, 2017, FDA advised the Information Collection Clearance
filed in accordance with § 10.20, must
USPTO that this human biological Officer, Room 14N39, 5600 Fishers
product had undergone a regulatory contain sufficient facts to merit an FDA
investigation, and must certify that a Lane, Rockville, MD 20857.
review period and that the approval of FOR FURTHER INFORMATION CONTACT: To
AFSTYLA represented the first true and complete copy of the petition
has been served upon the patent request more information on the
permitted commercial marketing or use proposed project or to obtain a copy of
of the product. Thereafter, the USPTO applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.) the data collection plans and draft
requested that FDA determine the instruments, email paperwork@hrsa.gov
product’s regulatory review period. Petitions should be in the format
specified in 21 CFR 10.30. or call Lisa Wright-Solomon, the HRSA
II. Determination of Regulatory Review Information Collection Clearance Officer
Period Submit petitions electronically to at (301) 443–1984.
https://www.regulations.gov at Docket SUPPLEMENTARY INFORMATION: When
FDA has determined that the
No. FDA–2013–S–0610. Submit written submitting comments or requesting
applicable regulatory review period for
petitions (two copies are required) to the information, please include the
AFSTYLA is 1,734 days. Of this time,
Dockets Management Staff (HFA–305), information request collection title for
1,371 days occurred during the testing
phase of the regulatory review period, Food and Drug Administration, 5630 reference.
while 363 days occurred during the Fishers Lane, Rm. 1061, Rockville, MD Information Collection Request Title:
approval phase. These periods of time 20852. Bureau of Health Workforce
were derived from the following dates: Dated: October 12, 2018. Performance Data Collection, OMB No.
1. The date an exemption under Leslie Kux, 0915–0061—Revision.
section 505(i) of the Federal Food, Drug, Abstract: Over 40 Bureau of Health
Associate Commissioner for Policy.
and Cosmetic Act (21 U.S.C. 355(i)) Workforce (BHW) programs award
[FR Doc. 2018–22696 Filed 10–17–18; 8:45 am] grants to health professions schools and
became effective: August 28, 2011. FDA
has verified the applicant’s claim that BILLING CODE 4164–01–P training programs across the United
States to develop, expand, and enhance
khammond on DSK30JT082PROD with NOTICES
the date the investigational new drug
application became effective was on training, and to strengthen the
August 28, 2011. distribution of the health workforce.
2. The date the application was These programs are governed by the
initially submitted with respect to the Public Health Service Act (42 U.S.C. 201
human biological product under section et seq.), specifically Titles III, VII, and
351 of the Public Health Service Act (42 VIII. Performance information about
U.S.C. 262): May 29, 2015. FDA has these health professions programs is
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Document Created: 2018-10-18 03:05:46
Document Modified: 2018-10-18 03:05:46
| 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 | |
| Contact | Beverly Friedman, Office of Regulatory | |
| FR Citation | 83 FR 52839 |
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