81 FR 65658 - Determination of Regulatory Review Period for Purposes of Patent Extension; BELVIQ
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 185 (September 23, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 185 (September 23, 2016)
| Page Range | 65658-65660 | |
| FR Document | 2016-22937 |
[Federal Register Volume 81, Number 185 (Friday, September 23, 2016)] [Notices] [Pages 65658-65660] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-22937] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2012-E-1231; FDA-2012-E-1232; and FDA-2012-E-1247] Determination of Regulatory Review Period for Purposes of Patent Extension; BELVIQ AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for BELVIQ and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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 November 22, 2016. Furthermore, any interested person may [[Page 65659]] petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by March 22, 2017. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: 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 Nos. FDA-2012-E-1231; FDA-2012-E-1232; and FDA-2012-E-1247, for ``Determination of Regulatory Review Period for Purposes of Patent Extension; BELVIQ.'' 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, BELVIQ (lorcaserin hydrochloride hemihydrate). BELVIQ is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults. Subsequent to this approval, the USPTO received patent term restoration applications for BELVIQ (U.S. Patent Nos. 6,953,787; 7,514,422; and 7,977,329) from Arena Pharmaceuticals, Inc., and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated February 13, 2013, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of BELVIQ 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 BELVIQ is 2,928 days. Of this time, 2,009 days occurred during the testing phase of the regulatory review period, while 919 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, [[Page 65660]] and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became effective: June 23, 2004. FDA has verified the Arena Pharmaceuticals, Inc. claim that June 23, 2004, is the date the investigational new drug application 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: December 22, 2009. The applicant claims December 18, 2009, as the date the NDA for BELVIQ was initially submitted. However, FDA records indicate that NDA 22-529 was submitted on December 22, 2009. 3. The date the application was approved: June 27, 2012. FDA has verified the applicant's claim that NDA 22-529 was approved on June 27, 2012. FDA has verified the applicant's claim that NDA 22-529 was approved on June 27, 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 1,174 days; 1,051 days; or 352 days of patent term extension, respectively. 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: September 19, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-22937 Filed 9-22-16; 8:45 am] BILLING CODE 4164-01-P
![65658 Federal Register / Vol. 81, No. 185 / Friday, September 23, 2016 / Notices
sufficient facts to merit an FDA 741–8138 (301–443–0572 in the notify interested persons regarding their
investigation. (See H. Rept. 857, part 1, Washington, DC area). A notice in the request to speak by November 14, 2016.
98th Cong., 2d sess., pp. 41–42, 1984.) Federal Register about last minute Persons attending FDA’s advisory
Petitions should be in the format modifications that impact a previously committee meetings are advised that the
specified in 21 CFR 10.30. announced advisory committee meeting Agency is not responsible for providing
Submit petitions electronically to cannot always be published quickly access to electrical outlets.
http://www.regulations.gov at Docket enough to provide timely notice. FDA welcomes the attendance of the
No. FDA–2013–S–0610. Submit written Therefore, you should always check the public at its advisory committee
petitions (two copies are required) to the Agency’s Web site at http:// meetings and will make every effort to
Division of Dockets Management (HFA– www.fda.gov/AdvisoryCommittees/ accommodate persons with disabilities.
305), Food and Drug Administration, default.htm and scroll down to the If you require accommodations due to a
5630 Fishers Lane, Rm. 1061, Rockville, appropriate advisory committee meeting disability, please contact Kalyani Bhatt
MD 20852. link, or call the advisory committee at least 7 days in advance of the
Dated: September 19, 2016. information line to learn about possible meeting.
Leslie Kux, modifications before coming to the FDA is committed to the orderly
Associate Commissioner for Policy. meeting. conduct of its advisory committee
SUPPLEMENTARY INFORMATION:
meetings. Please visit our Web site at
[FR Doc. 2016–22935 Filed 9–22–16; 8:45 am]
Agenda: The committee will discuss http://www.fda.gov/
BILLING CODE 4164–01–P
appropriate clinical trial design features, AdvisoryCommittees/
including acceptable endpoints for AboutAdvisoryCommittees/
DEPARTMENT OF HEALTH AND demonstrating clinical benefit, for drugs ucm111462.htm for procedures on
HUMAN SERVICES intended to treat secondary public conduct during advisory
hypogonadism while preserving or committee meetings.
Food and Drug Administration improving testicular function, including Notice of this meeting is given under
spermatogenesis. the Federal Advisory Committee Act (5
[Docket No. FDA–2016–N–0001] U.S.C. app. 2).
FDA intends to make background
Bone, Reproductive and Urologic material available to the public no later Dated: September 20, 2016.
Drugs Advisory Committee; Notice of than 2 business days before the meeting. Janice M. Soreth,
Meeting If FDA is unable to post the background Acting Associate Commissioner, Special
material on its Web site prior to the Medical Programs.
AGENCY: Food and Drug Administration, meeting, the background material will [FR Doc. 2016–22925 Filed 9–22–16; 8:45 am]
HHS. be made publicly available at the BILLING CODE 4164–01–P
ACTION: Notice. location of the advisory committee
SUMMARY: The Food and Drug meeting, and the background material
Administration (FDA) announces a will be posted on FDA’s Web site after DEPARTMENT OF HEALTH AND
forthcoming public advisory committee the meeting. Background material is HUMAN SERVICES
meeting of the Bone, Reproductive and available at http://www.fda.gov/
AdvisoryCommittees/Calendar/ Food and Drug Administration
Urologic Drugs Advisory Committee.
The general function of the committee is default.htm. Scroll down to the [Docket Nos. FDA–2012–E–1231; FDA–
to provide advice and recommendations appropriate advisory committee meeting 2012–E–1232; and FDA–2012–E–1247]
to the Agency on FDA’s regulatory link.
issues. The meeting will be open to the Procedure: Interested persons may Determination of Regulatory Review
public. present data, information, or views, Period for Purposes of Patent
orally or in writing, on issues pending Extension; BELVIQ
DATES: The meeting will be held on
before the committee. Written
December 6, 2016, from 8 a.m. to 5 p.m. submissions may be made to the contact AGENCY: Food and Drug Administration,
ADDRESSES: Tommy Douglas Conference person on or before November 21, 2016. HHS.
Center, 10000 New Hampshire Ave., Oral presentations from the public will ACTION: Notice.
Silver Spring, MD 20903. The be scheduled between approximately 1
conference center’s telephone number is p.m. and 2 p.m. Those individuals SUMMARY: The Food and Drug
240–645–4000. Answers to commonly interested in making formal oral Administration (FDA) has determined
asked questions including information presentations should notify the contact the regulatory review period for BELVIQ
regarding accommodations due to a person and submit a brief statement of and is publishing this notice of that
disability, visitor parking, and the general nature of the evidence or determination as required by law. FDA
transportation may be accessed at: arguments they wish to present, the has made the determination because of
http://www.fda.gov/ names and addresses of proposed the submission of applications to the
AdvisoryCommittees/ participants, and an indication of the Director of the U.S. Patent and
AboutAdvisoryCommittees/ approximate time requested to make Trademark Office (USPTO), Department
ucm408555.htm. their presentation on or before of Commerce, for the extension of a
FOR FURTHER INFORMATION CONTACT: November 10, 2016. Time allotted for patent which claims that human drug
Kalyani Bhatt, Center for Drug each presentation may be limited. If the product.
sradovich on DSK3GMQ082PROD with NOTICES
Evaluation and Research, Food and number of registrants requesting to DATES: Anyone with knowledge that any
Drug Administration, 10903 New speak is greater than can be reasonably of the dates as published (in the
Hampshire Ave., Bldg. 31, Rm. 2417, accommodated during the scheduled SUPPLEMENTARY INFORMATION section) are
Silver Spring, MD 20993–0002, 301– open public hearing session, FDA may incorrect may submit either electronic
796–9001, Fax: 301–847–8533, email: conduct a lottery to determine the or written comments and ask for a
BRUDAC@fda.hhs.gov, or FDA Advisory speakers for the scheduled open public redetermination by November 22, 2016.
Committee Information Line, 1–800– hearing session. The contact person will Furthermore, any interested person may
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![65660 Federal Register / Vol. 81, No. 185 / Friday, September 23, 2016 / Notices
and Cosmetic Act (the FD&C Act) (21 DEPARTMENT OF HEALTH AND do not wish to be made available to the
U.S.C. 355(i)) became effective: June 23, HUMAN SERVICES public, submit the comment as a
2004. FDA has verified the Arena written/paper submission and in the
Pharmaceuticals, Inc. claim that June Food and Drug Administration manner detailed (see ‘‘Written/Paper
23, 2004, is the date the investigational [Docket No. FDA–2012–D–0881] Submissions’’ and ‘‘Instructions’’).
new drug application became effective. Written/Paper Submissions
2. The date the application was Self-Identification of Generic Drug
Facilities, Sites, and Organizations; Submit written/paper submissions as
initially submitted with respect to the follows:
Guidance for Industry; Availability
human drug product under section • Mail/Hand delivery/Courier (for
505(b) of the FD&C Act: December 22, AGENCY: Food and Drug Administration, written/paper submissions): Division of
2009. The applicant claims December HHS. Dockets Management (HFA–305), Food
18, 2009, as the date the NDA for ACTION: Notice of availability. and Drug Administration, 5630 Fishers
BELVIQ was initially submitted. Lane, Rm. 1061, Rockville, MD 20852.
However, FDA records indicate that SUMMARY: The Food and Drug • For written/paper comments
Administration (FDA or Agency) is submitted to the Division of Dockets
NDA 22–529 was submitted on
announcing the availability of a Management, FDA will post your
December 22, 2009.
guidance for industry entitled ‘‘Self- comment, as well as any attachments,
3. The date the application was Identification of Generic Drug Facilities, except for information submitted,
approved: June 27, 2012. FDA has Sites, and Organizations.’’ On July 9, marked and identified, as confidential,
verified the applicant’s claim that NDA 2012, the Generic Drug User Fee if submitted as detailed in
22–529 was approved on June 27, 2012. Amendments of 2012 (GDUFA) was ‘‘Instructions.’’
FDA has verified the applicant’s claim signed into law by the President. Instructions: All submissions received
that NDA 22–529 was approved on June GDUFA, designed to speed the delivery must include the Docket No. FDA–
27, 2012. of safe and effective generic drugs to the 2012–D–0881 for ‘‘Self-Identification of
This determination of the regulatory public and reduce costs to industry, Generic Drug Facilities, Sites, and
review period establishes the maximum requires that generic drug facilities, Organizations.’’ Received comments
potential length of a patent extension. sites, and organizations around the will be placed in the docket and, except
However, the USPTO applies several world provide identification for those submitted as ‘‘Confidential
statutory limitations in its calculations information annually to FDA. This Submissions,’’ publicly viewable at
guidance is intended to assist industry http://www.regulations.gov or at the
of the actual period for patent extension.
to meet the self-identification Division of Dockets Management
In its applications for patent extension,
requirement. It explains who is required between 9 a.m. and 4 p.m., Monday
this applicant seeks 1,174 days; 1,051
to self-identify, what information must through Friday.
days; or 352 days of patent term • Confidential Submissions—To
be requested, how the information
extension, respectively. should be submitted to FDA, and what submit a comment with confidential
III. Petitions the penalty is for failure to self-identify. information that you do not wish to be
DATES: Submit either electronic or made publicly available, submit your
Anyone with knowledge that any of written comments on Agency guidances comments only as a written/paper
the dates as published are incorrect may at any time. submission. You should submit two
submit either electronic or written ADDRESSES: You may submit comments copies total. One copy will include the
comments and ask for a redetermination as follows: information you claim to be confidential
(see DATES). Furthermore, any interested with a heading or cover note that states
person may petition FDA for a Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
determination regarding whether the Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
applicant for extension acted with due following way: Agency will review this copy, including
diligence during the regulatory review • Federal eRulemaking Portal: http:// the claimed confidential information, in
period. To meet its burden, the petition www.regulations.gov. Follow the its consideration of comments. The
must be timely (see DATES) and contain instructions for submitting comments. second copy, which will have the
sufficient facts to merit an FDA Comments submitted electronically, claimed confidential information
investigation. (See H. Rept. 857, part 1, including attachments, to http:// redacted/blacked out, will be available
98th Cong., 2d sess., pp. 41–42, 1984.) www.regulations.gov will be posted to for public viewing and posted on http://
Petitions should be in the format the docket unchanged. Because your www.regulations.gov. Submit both
comment will be made public, you are copies to the Division of Dockets
specified in 21 CFR 10.30.
solely responsible for ensuring that your Management. If you do not wish your
Submit petitions electronically to comment does not include any name and contact information to be
http://www.regulations.gov at Docket confidential information that you or a made publicly available, you can
No. FDA–2013–S–0610. Submit written third party may not wish to be posted, provide this information on the cover
petitions (two copies are required) to the such as medical information, your or sheet and not in the body of your
Division of Dockets Management (HFA– anyone else’s Social Security number, or comments and you must identify this
305), Food and Drug Administration, confidential business information, such information as ‘‘confidential.’’ Any
5630 Fishers Lane, Rm. 1061, Rockville, information marked as ‘‘confidential’’
sradovich on DSK3GMQ082PROD with NOTICES
as a manufacturing process. Please note
MD 20852. that if you include your name, contact will not be disclosed except in
Dated: September 19, 2016. information, or other information that accordance with 21 CFR 10.20 and other
identifies you in the body of your applicable disclosure law. For more
Leslie Kux,
comments, that information will be information about FDA’s posting of
Associate Commissioner for Policy. posted on http://www.regulations.gov. comments to public dockets, see 80 FR
[FR Doc. 2016–22937 Filed 9–22–16; 8:45 am] • If you want to submit a comment 56469, September 18, 2015, or access
BILLING CODE 4164–01–P with confidential information that you the information at: http://www.fda.gov/
VerDate Sep<11>2014 18:22 Sep 22, 2016 Jkt 238001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\23SEN1.SGM 23SEN1](https://thefederalregister.org/doc/81_FR_65843/page/3.svg)
Document Created: 2016-09-23 01:43:24
Document Modified: 2016-09-23 01:43:24
| 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 November 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 March 22, 2017. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information. | |
| Contact | Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600. | |
| FR Citation | 81 FR 65658 |
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