81 FR 35026 - Determination of Regulatory Review Period for Purposes of Patent Extension; OSPHENA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 105 (June 1, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 105 (June 1, 2016)
| Page Range | 35026-35028 | |
| FR Document | 2016-12823 |
[Federal Register Volume 81, Number 105 (Wednesday, June 1, 2016)] [Notices] [Pages 35026-35028] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-12823] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-E-1235] Determination of Regulatory Review Period for Purposes of Patent Extension; OSPHENA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for OSPHENA 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 drug 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 August 1, 2016. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence [[Page 35027]] during the regulatory review period by November 28, 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''). 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 No. FDA-2014-E-1235 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; OSPHENA.'' 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 drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug 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 drug 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 drug product OSPHENA (ospemifene). OSPHENA is indicated for treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause. Subsequent to this approval, the USPTO received a patent term restoration application for OSPHENA (U.S. Patent No. 6,245,819) from Hormos Medical Ltd., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated May 11, 2015, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of OSPHENA 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 OSPHENA is 3,585 days. Of this time, 3,278 days occurred during the testing phase of the regulatory review period, while 307 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 (the FD&C Act) (21 U.S.C. 355(i)) became effective: May 7, 2003. FDA has verified the Hormos Medical Ltd. claim that May 7, 2003, is [[Page 35028]] the date the investigational new drug application (IND) became effective. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: April 26, 2012. FDA has verified the applicant's claim that the new drug application (NDA) for OSPHENA (NDA 203505) was initially submitted on April 26, 2012. 3. The date the application was approved: February 26, 2013. FDA has verified the applicant's claim that NDA 203505 was approved on February 26, 2013. 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 1,826 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 http://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: May 25, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-12823 Filed 5-31-16; 8:45 am] BILLING CODE 4164-01-P
![35026 Federal Register / Vol. 81, No. 105 / Wednesday, June 1, 2016 / Notices
with a heading or cover note that states evaluating the adhesive performance of sensitization) that may be necessary to
‘‘THIS DOCUMENT CONTAINS a TDS submitted in support of an support the bioequivalence (BE) of a
CONFIDENTIAL INFORMATION.’’ The ANDA. The recommendations in this proposed generic TDS drug product to
Agency will review this copy, including guidance relate exclusively to TDS its RLD.
the claimed confidential information, in adhesion studies submitted in support This draft guidance is being issued
its consideration of comments. The of an ANDA. consistent with FDA’s good guidance
second copy, which will have the The amount of drug delivered into practices regulation (21 CFR 10.115).
claimed confidential information and through the skin from a TDS is The draft guidance, when finalized, will
redacted/blacked out, will be available dependent, in part, on the surface area represent the current thinking of FDA
for public viewing and posted on http:// dosed. It is expected that the entire on ‘‘Assessing Adhesion with
www.regulations.gov. Submit both surface area of a TDS should remain Transdermal Delivery Systems and
copies to the Division of Dockets consistently and uniformly adhered to Topical Patches for ANDAs.’’ It does not
Management. If you do not wish your the skin throughout the duration of wear establish any rights for any person and
name and contact information to be under the conditions of use included in is not binding on FDA or the public.
made publicly available, you can the product label. Under circumstances You can use an alternative approach if
provide this information on the cover in which a TDS loses its adherence it satisfies the requirements of the
sheet and not in the body of your during wear, the amount of drug applicable statutes and regulations.
comments and you must identify this delivered to the patient may be reduced.
During the course of the product’s II. Electronic Access
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’ labeled wear period, a TDS is Persons with access to the Internet
will not be disclosed except in reasonably expected to encounter may obtain the draft guidance at either
accordance with 21 CFR 10.20 and other torsional strains arising from anatomical http://www.fda.gov/Drugs/Guidance
applicable disclosure law. For more movements, changes in environmental ComplianceRegulatoryInformation/
information about FDA’s posting of temperature or humidity such as the Guidances/default.htm or http://
comments to public dockets, see 80 FR daily exposure to water (e.g., during www.regulations.gov.
56469, September 18, 2015, or access routine showering), and contact with
clothing, bedding or other surfaces. TDS Dated: May 26, 2016.
the information at: http://www.fda.gov/ Leslie Kux,
regulatoryinformation/dockets/ products that do not maintain consistent
and uniform adhesion with the skin Associate Commissioner for Policy.
default.htm.
Docket: For access to the docket to under the range of conditions [FR Doc. 2016–12822 Filed 5–31–16; 8:45 am]
read background documents or the experienced during the labeled wear BILLING CODE 4164–01–P
electronic and written/paper comments period for the TDS can result in varying
received, go to http:// degrees of TDS detachment, including
complete detachment, at different times DEPARTMENT OF HEALTH AND
www.regulations.gov and insert the
during the course of product wear. HUMAN SERVICES
docket number, found in brackets in the
When the adhesion characteristics of
heading of this document, into the Food and Drug Administration
a TDS are not sufficiently robust, as
‘‘Search’’ box and follow the prompts evaluated against its labeled conditions
and/or go to the Division of Dockets [Docket No. FDA–2014–E–1235]
of use, the TDS may exhibit variability
Management, 5630 Fishers Lane, Rm. in the area that is in contact with the Determination of Regulatory Review
1061, Rockville, MD 20852. skin. In such situations where a TDS is Period for Purposes of Patent
Submit written requests for single partially detached, there may be Extension; OSPHENA
copies of the draft guidance to the uncertainty about the resulting drug
Division of Drug Information, Center for delivery profile and, hence, uncertainty AGENCY: Food and Drug Administration,
Drug Evaluation and Research, Food about the rate and extent of drug HHS.
and Drug Administration, 10001 New absorption from the TDS. In addition, as ACTION: Notice.
Hampshire Ave., Hillandale Building, the potential for complete detachment
4th Floor, Silver Spring, MD 20993– of the TDS increases, so does the risk of SUMMARY: The Food and Drug
0002. Send one self-addressed adhesive unintentional exposure of the drug Administration (FDA) has determined
label to assist that office in processing product to an unintended recipient (e.g., the regulatory review period for
your requests. See the SUPPLEMENTARY a household member who may OSPHENA and is publishing this notice
INFORMATION section for electronic potentially be a child). of that determination as required by
access to the draft guidance document. This guidance describes the law. FDA has made the determination
FOR FURTHER INFORMATION CONTACT: Kris recommended approach to the adhesion because of the submission of an
Andre, Center for Drug Evaluation and clinical study design and, therefore, will application to the Director of the U.S.
Research, Food and Drug supersede the recommendations related Patent and Trademark Office (USPTO),
Administration, 10903 New Hampshire to adhesion studies provided in Department of Commerce, for the
Ave., Bldg. 75, Rm. 4726, Silver Spring, individual product-specific guidances extension of a patent which claims that
MD 20993–0002, 240–402–7959. published prior to the date of human drug product.
SUPPLEMENTARY INFORMATION: publication of this guidance. This DATES: Anyone with knowledge that any
guidance, once finalized, is intended to of the dates as published (in the
I. Background provide updated recommendations for SUPPLEMENTARY INFORMATION section) are
sradovich on DSK3TPTVN1PROD with NOTICES
FDA is announcing the availability of the design and conduct of adhesion incorrect may submit either electronic
a draft guidance for industry entitled studies submitted in support of an or written comments and ask for a
‘‘Assessing Adhesion with Transdermal ANDA for a TDS. FDA recommends that redetermination by August 1, 2016.
Delivery Systems and Topical Patches applicants consult this guidance in Furthermore, any interested person may
for ANDAs.’’ This draft guidance conjunction with any relevant product- petition FDA for a determination
provides recommendations for the specific guidance documents when regarding whether the applicant for
design and conduct of clinical studies considering other studies (e.g. irritation, extension acted with due diligence
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![35028 Federal Register / Vol. 81, No. 105 / Wednesday, June 1, 2016 / Notices
the date the investigational new drug ACTION: Notice. and Drug Administration, 5630 Fishers
application (IND) became effective. Lane, Rm. 1061, Rockville, MD 20852.
2. The date the application was SUMMARY: The Food and Drug • For written/paper comments
initially submitted with respect to the Administration (FDA) has determined submitted to the Division of Dockets
human drug product under section the regulatory review period for Management, FDA will post your
505(b) of the FD&C Act: April 26, 2012. MEKINIST and is publishing this notice comment, as well as any attachments,
FDA has verified the applicant’s claim of that determination as required by except for information submitted,
that the new drug application (NDA) for law. FDA has made the determination marked and identified, as confidential,
OSPHENA (NDA 203505) was initially because of the submission of an if submitted as detailed in
submitted on April 26, 2012. application to the Director of the U.S. ‘‘Instructions.’’
3. The date the application was Patent and Trademark Office (USPTO), Instructions: All submissions received
approved: February 26, 2013. FDA has Department of Commerce, for the must include the Docket No. FDA–
verified the applicant’s claim that NDA extension of a patent which claims that 2014–E–2340 for ‘‘Determination of
203505 was approved on February 26, human drug product. Regulatory Review Period for Purposes
2013. DATES: Anyone with knowledge that any of Patent Extension; MEKINIST.’’
This determination of the regulatory of the dates as published (in the Received comments will be placed in
review period establishes the maximum SUPPLEMENTARY INFORMATION section) are the docket and, except for those
potential length of a patent extension. incorrect may submit either electronic submitted as ‘‘Confidential
However, the USPTO applies several or written comments and ask for a Submissions,’’ publicly viewable at
statutory limitations in its calculations redetermination by August 1, 2016. http://www.regulations.gov or at the
of the actual period for patent extension. Furthermore, any interested person may Division of Dockets Management
In its application for patent extension, petition FDA for a determination between 9 a.m. and 4 p.m., Monday
this applicant seeks 1,826 days of patent regarding whether the applicant for through Friday.
term extension. extension acted with due diligence • Confidential Submissions—To
during the regulatory review period by submit a comment with confidential
III. Petitions
November 28, 2016. See ‘‘Petitions’’ in information that you do not wish to be
Anyone with knowledge that any of the SUPPLEMENTARY INFORMATION section made publicly available, submit your
the dates as published are incorrect may for more information. comments only as a written/paper
submit either electronic or written submission. You should submit two
ADDRESSES: You may submit comments
comments and ask for a redetermination copies total. One copy will include the
as follows:
(see DATES). Furthermore, any interested information you claim to be confidential
person may petition FDA for a Electronic Submissions with a heading or cover note that states
determination regarding whether the Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
applicant for extension acted with due following way: CONFIDENTIAL INFORMATION’’. The
diligence during the regulatory review • Federal eRulemaking Portal: http:// Agency will review this copy, including
period. To meet its burden, the petition www.regulations.gov. Follow the the claimed confidential information, in
must be timely (see DATES) and contain instructions for submitting comments. its consideration of comments. The
sufficient facts to merit an FDA Comments submitted electronically, second copy, which will have the
investigation. (See H. Rept. 857, part 1, including attachments, to http:// claimed confidential information
98th Cong., 2d sess., pp. 41–42, 1984.) www.regulations.gov will be posted to redacted/blacked out, will be available
Petitions should be in the format the docket unchanged. Because your for public viewing and posted on http://
specified in 21 CFR 10.30. comment will be made public, you are www.regulations.gov. Submit both
Submit petitions electronically to solely responsible for ensuring that your copies to the Division of Dockets
http://www.regulations.gov at Docket comment does not include any Management. If you do not wish your
No. FDA–2013–S–0610. Submit written confidential information that you or a name and contact information to be
petitions (two copies are required) to the third party may not wish to be posted, made publicly available, you can
Division of Dockets Management (HFA– such as medical information, your or provide this information on the cover
305), Food and Drug Administration, anyone else’s Social Security number, or sheet and not in the body of your
5630 Fishers Lane, Rm. 1061, Rockville, confidential business information, such comments and you must identify this
MD 20852. as a manufacturing process. Please note information as ‘‘confidential.’’ Any
Dated: May 25, 2016. that if you include your name, contact information marked as ‘‘confidential’’
Leslie Kux, information, or other information that will not be disclosed except in
Associate Commissioner for Policy. identifies you in the body of your accordance with 21 CFR 10.20 and other
comments, that information will be applicable disclosure law. For more
[FR Doc. 2016–12823 Filed 5–31–16; 8:45 am]
posted on http://www.regulations.gov. information about FDA’s posting of
BILLING CODE 4164–01–P
• If you want to submit a comment comments to public dockets, see 80 FR
with confidential information that you 56469, September 18, 2015, or access
DEPARTMENT OF HEALTH AND do not wish to be made available to the the information at: http://www.fda.gov/
HUMAN SERVICES public, submit the comment as a regulatoryinformation/dockets/
written/paper submission and in the default.htm.
Food and Drug Administration manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
read background documents or the
sradovich on DSK3TPTVN1PROD with NOTICES
[Docket No. FDA–2014–E–2340]
Submissions’’ and ‘‘Instructions’’).
electronic and written/paper comments
Written/Paper Submissions received, go to http://
Determination of Regulatory Review
Submit written/paper submissions as www.regulations.gov and insert the
Period for Purposes of Patent
follows: docket number, found in brackets in the
Extension; MEKINIST
• Mail/Hand delivery/Courier (for heading of this document, into the
AGENCY: Food and Drug Administration, written/paper submissions): Division of ‘‘Search’’ box and follow the prompts
HHS. Dockets Management (HFA–305), Food and/or go to the Division of Dockets
VerDate Sep<11>2014 21:59 May 31, 2016 Jkt 238001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\01JNN1.SGM 01JNN1](https://thefederalregister.org/doc/81_FR_35131/page/3.svg)
Document Created: 2018-02-08 07:27:04
Document Modified: 2018-02-08 07:27:04
| 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 August 1, 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 November 28, 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 | 81 FR 35026 |
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