80 FR 79903 - Determination of Regulatory Review Period for Purposes of Patent Extension; JETREA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 246 (December 23, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 246 (December 23, 2015)
| Page Range | 79903-79905 | |
| FR Document | 2015-32247 |
[Federal Register Volume 80, Number 246 (Wednesday, December 23, 2015)] [Notices] [Pages 79903-79905] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-32247] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2013-E-1433; FDA-2013-E-1435; FDA-2013-E-1437] Determination of Regulatory Review Period for Purposes of Patent Extension; JETREA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for JETREA 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 February 22, 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 June 20, 2016. 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''). [[Page 79904]] 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-2013-E-1433; FDA-2013-E-1435; and FDA-2013-E-1437 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; JETREA.'' 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 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 JETREA (ocriplasmin). JETREA is indicated for the treatment of symptomatic vitreomacular adhesion. Subsequent to this approval, USPTO received patent term restoration applications for JETREA (U.S. Patent Nos. 7,445,775; 7,547,435; and 7,914,783) from ThromboGenics NV, and the USPTO requested FDA's assistance in determining these patents' eligibility for patent term restoration. In a letter dated January 31, 2014, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of JETREA 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 JETREA is 2,171 days. Of this time, 1,987 days occurred during the testing phase of the regulatory review period, while 184 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: November 9, 2006. The applicant claims November 11, 2006, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was November 9, 2006, when the investigational studies were allowed to proceed. 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): April 17, 2012. FDA has verified the applicant's claim that the biologics license application (BLA) for JETREA (BLA 125422/0) was initially submitted on April 17, 2012. 3. The date the application was approved: October 17, 2012. FDA has verified the applicant's claim that BLA 125422/0 was approved on October 17, 2012. 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 2,169 days; 761 days; or 435 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 [[Page 79905]] 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. Petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: December 15, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-32247 Filed 12-22-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 246 / Wednesday, December 23, 2015 / Notices 79903
Management and Budget, Paperwork DEPARTMENT OF HEALTH AND to provide information that is requested
Reduction Project, Email: OIRA_ HUMAN SERVICES from all Head Start and Early Head Start
SUBMISSION@OMB.EOP.GOV, Attn: grantees applying for continuation
Desk Officer for the Administration for Administration for Children and grants. The application and budget
Children and Families. Families forms are available in the Head Start
Enterprise System (HSES), a secure
Robert Sargis, Proposed Information Collection Web-based system, which transmits
Reports Clearance Officer. Activity; Comment Request completed applications to Regional and
[FR Doc. 2015–32097 Filed 12–22–15; 8:45 am] Proposed Projects Central Offices. The Administration for
BILLING CODE 4184–01–P Children and Families believes that this
Title: Head Start Grant Application
application instrument has made the
and Budget Instruments.
OMB No.: 0970–0207. process of applying for a Head Start
Description: The Office of Head Start continuation grant more efficient for
is proposing to renew, without changes, applicants.
the Head Start Grant Application and Respondents: Head Start and Early
Budget Instrument, which grantees use Head Start grantees.
ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response
HS grant and budget instrument ..................................................................... 2,000 1 33 66,000
Estimated Total Annual Burden comments and suggestions submitted petition FDA for a determination
Hours: 66,000. within 60 days of this publication. regarding whether the applicant for
In compliance with the requirements extension acted with due diligence
Robert Sargis,
of Section 506(c)(2)(A) of the Paperwork during the regulatory review period by
Reports Clearance Officer.
Reduction Act of 1995, the June 20, 2016. See ‘‘Petitions’’ in the
[FR Doc. 2015–32241 Filed 12–22–15; 8:45 am] SUPPLEMENTARY INFORMATION section for
Administration for Children and BILLING CODE 4184–01–P more information.
Families is soliciting public comment
on the specific aspects of the ADDRESSES: You may submit comments
information collection described above. DEPARTMENT OF HEALTH AND as follows:
Copies of the proposed collection of HUMAN SERVICES
Electronic Submissions
information can be obtained and
comments may be forwarded by writing Food and Drug Administration Submit electronic comments in the
to the Administration for Children and [Docket Nos. FDA–2013–E–1433; FDA– following way:
Families, Office of Planning, Research 2013–E–1435; FDA–2013–E–1437] • Federal eRulemaking Portal: http://
and Evaluation, 370 L’Enfant www.regulations.gov. Follow the
Promenade SW., Washington, DC 20447, Determination of Regulatory Review instructions for submitting comments.
Attn: ACF Reports Clearance Officer. Period for Purposes of Patent Comments submitted electronically,
Email address: infocollection@ Extension; JETREA including attachments, to http://
acf.hhs.gov. All requests should be AGENCY: Food and Drug Administration, www.regulations.gov will be posted to
identified by the title of the information HHS. the docket unchanged. Because your
collection. comment will be made public, you are
ACTION: Notice.
The Department specifically requests solely responsible for ensuring that your
comments on: (a) Whether the proposed SUMMARY: The Food and Drug comment does not include any
collection of information is necessary Administration (FDA) has determined confidential information that you or a
for the proper performance of the the regulatory review period for JETREA third party may not wish to be posted,
functions of the agency, including and is publishing this notice of that such as medical information, your or
determination as required by law. FDA anyone else’s Social Security number, or
whether the information shall have
has made the determination because of confidential business information, such
practical utility; (b) the accuracy of the
the submission of an application to the as a manufacturing process. Please note
agency’s estimate of the burden of the
Director of the U.S. Patent and that if you include your name, contact
proposed collection of information; (c) information, or other information that
Trademark Office (USPTO), Department
the quality, utility, and clarity of the identifies you in the body of your
of Commerce, for the extension of a
information to be collected; and (d) comments, that information will be
patent which claims that human
ways to minimize the burden biological product. posted on http://www.regulations.gov.
information to be collected; and (e)
• If you want to submit a comment
tkelley on DSK3SPTVN1PROD with NOTICES
DATES: Anyone with knowledge that any
ways to minimize the burden of the
of the dates as published (see the with confidential information that you
collection of information on
SUPPLEMENTARY INFORMATION section) are do not wish to be made available to the
respondents, including through the use
incorrect may submit either electronic public, submit the comment as a
of automated collection techniques or or written comments and ask for a written/paper submission and in the
other forms of information technology. redetermination by February 22, 2016. manner detailed (see ‘‘Written/Paper
Consideration will be given to Furthermore, any interested person may Submissions’’ and ‘‘Instructions’’).
VerDate Sep<11>2014 18:05 Dec 22, 2015 Jkt 238001 PO 00000 Frm 00087 Fmt 4703 Sfmt 4703 E:\FR\FM\23DEN1.SGM 23DEN1](https://thefederalregister.org/doc/80_FR_80149/page/1.svg)
![Federal Register / Vol. 80, No. 246 / Wednesday, December 23, 2015 / Notices 79905
person may petition FDA for a ADDRESSES: You may submit comments made publicly available, submit your
determination regarding whether the as follows: comments only as a written/paper
applicant for extension acted with due submission. You should submit two
Electronic Submissions
diligence during the regulatory review copies total. One copy will include the
period. To meet its burden, the petition Submit electronic comments in the information you claim to be confidential
must be timely (see DATES) and contain following way: with a heading or cover note that states
sufficient facts to merit an FDA • Federal eRulemaking Portal: http:// ‘‘THIS DOCUMENT CONTAINS
investigation. (See H. Rept. 857, part 1, www.regulations.gov. Follow the CONFIDENTIAL INFORMATION’’. The
98th Cong., 2d sess., pp. 41–42, 1984.) instructions for submitting comments. Agency will review this copy, including
Petitions should be in the format Comments submitted electronically, the claimed confidential information, in
specified in 21 CFR 10.30. including attachments, to http:// its consideration of comments. The
Submit petitions electronically to www.regulations.gov will be posted to second copy, which will have the
http://www.regulations.gov at Docket the docket unchanged. Because your claimed confidential information
No. FDA–2013–S–0610. Submit written comment will be made public, you are redacted/blacked out, will be available
petitions (two copies are required) to the solely responsible for ensuring that your for public viewing and posted on
Division of Dockets Management (HFA– comment does not include any http://www.regulations.gov. Submit
305), Food and Drug Administration, confidential information that you or a both copies to the Division of Dockets
5630 Fishers Lane, Rm. 1061, Rockville, third party may not wish to be posted, Management. If you do not wish your
MD 20852. Petitions that have not been such as medical information, your or name and contact information to be
made publicly available on http:// anyone else’s Social Security number, or made publicly available, you can
www.regulations.gov may be viewed in confidential business information, such provide this information on the cover
the Division of Dockets Management as a manufacturing process. Please note sheet and not in the body of your
between 9 a.m. and 4 p.m., Monday that if you include your name, contact comments and you must identify this
through Friday. information, or other information that information as ‘‘confidential.’’ Any
identifies you in the body of your information marked as ‘‘confidential’’
Dated: December 15, 2015.
comments, that information will be will not be disclosed except in
Leslie Kux, posted on http://www.regulations.gov. accordance with 21 CFR 10.20 and other
Associate Commissioner for Policy. • If you want to submit a comment applicable disclosure law. For more
[FR Doc. 2015–32247 Filed 12–22–15; 8:45 am] with confidential information that you information about FDA’s posting of
BILLING CODE 4164–01–P do not wish to be made available to the comments to public dockets, see 80 FR
public, submit the comment as a 56469, September 18, 2015, or access
written/paper submission and in the the information at: http://www.fda.gov/
DEPARTMENT OF HEALTH AND manner detailed (see ‘‘Written/Paper regulatoryinformation/dockets/
HUMAN SERVICES Submissions’’ and ‘‘Instructions’’). default.htm.
Written/Paper Submissions Docket: For access to the docket to
Food and Drug Administration read background documents or the
Submit written/paper submissions as electronic and written/paper comments
[Docket No. FDA–2012–N–0976] follows: received, go to http://
• Mail/Hand delivery/Courier (for www.regulations.gov and insert the
Agency Information Collection written/paper submissions): Division of docket number, found in brackets in the
Activities; Proposed Collection; Dockets Management (HFA–305), Food heading of this document, into the
Comment Request; Guidance: and Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
Emergency Use Authorization of Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Division of Dockets
Medical Products • For written/paper comments Management, 5630 Fishers Lane, Rm.
submitted to the Division of Dockets 1061, Rockville, MD 20852.
AGENCY: Food and Drug Administration, Management, FDA will post your
HHS. FOR FURTHER INFORMATION CONTACT: FDA
comment, as well as any attachments,
ACTION: Notice. PRA Staff, Office of Operations, Food
except for information submitted,
and Drug Administration, 8455
marked and identified, as confidential,
SUMMARY: The Food and Drug Colesville Rd., COLE–14526, Silver
if submitted as detailed in
Administration (FDA) is announcing an Spring, MD 20993–0002, PRAStaff@
‘‘Instructions.’’
opportunity for public comment on the Instructions: All submissions received fda.hhs.gov.
proposed collection of certain must include the Docket No. FDA– SUPPLEMENTARY INFORMATION: Under the
information by the Agency. Under the 2012–N–0976 for ‘‘Agency Information PRA (44 U.S.C. 3501–3520), Federal
Paperwork Reduction Act of 1995 (the Collection Activities; Proposed Agencies must obtain approval from the
PRA), Federal Agencies are required to Collection; Comment Request; Office of Management and Budget
publish notice in the Federal Register Guidance: Emergency Use (OMB) for each collection of
concerning each proposed collection of Authorization of Medical Products.’’ information they conduct or sponsor.
information, including each proposed Received comments will be placed in ‘‘Collection of information’’ is defined
extension of an existing collection of the docket and, except for those in 44 U.S.C. 3502(3) and 5 CFR
information, and to allow 60 days for submitted as ‘‘Confidential 1320.3(c) and includes Agency requests
public comment in response to the Submissions,’’ publicly viewable at or requirements that members of the
notice. This notice solicits comments on
tkelley on DSK3SPTVN1PROD with NOTICES
http://www.regulations.gov or at the public submit reports, keep records, or
the proposed extension of the collection Division of Dockets Management provide information to a third party.
of information related to emergency use between 9 a.m. and 4 p.m., Monday Section 3506(c)(2)(A) of the PRA (44
authorizations by the Agency. through Friday. U.S.C. 3506(c)(2)(A)) requires Federal
DATES: Submit either electronic or • Confidential Submissions—To Agencies to provide a 60-day notice in
written comments on the collection of submit a comment with confidential the Federal Register concerning each
information by February 22, 2016. information that you do not wish to be proposed collection of information,
VerDate Sep<11>2014 18:05 Dec 22, 2015 Jkt 238001 PO 00000 Frm 00089 Fmt 4703 Sfmt 4703 E:\FR\FM\23DEN1.SGM 23DEN1](https://thefederalregister.org/doc/80_FR_80149/page/3.svg)
Document Created: 2018-03-02 09:20:14
Document Modified: 2018-03-02 09:20:14
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Anyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by February 22, 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 June 20, 2016. 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 | 80 FR 79903 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR