83 FR 7196 - Determination of Regulatory Review Period for Purposes of Patent Extension; MAESTRO RECHARGEABLE SYSTEM
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 34 (February 20, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 34 (February 20, 2018)
| Page Range | 7196-7198 | |
| FR Document | 2018-03343 |
[Federal Register Volume 83, Number 34 (Tuesday, February 20, 2018)] [Notices] [Pages 7196-7198] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-03343] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-E-1187] Determination of Regulatory Review Period for Purposes of Patent Extension; MAESTRO RECHARGEABLE SYSTEM 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 MAESTRO RECHARGEABLE SYSTEM 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 medical device. 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 April 23, 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 August 20, 2018. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 23, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 23, 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-1187 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; MAESTRO RECHARGEABLE SYSTEM.'' 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 [[Page 7197]] 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 medical devices, the testing phase begins with a clinical investigation of the device and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the device and continues until permission to market the device is granted. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (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 medical device will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(3)(B). FDA has approved for marketing the medical device MAESTRO RECHARGEABLE SYSTEM. MAESTRO RECHARGEABLE SYSTEM is indicated for use in weight reduction in patients aged 18 years through adulthood who have a body mass index (BMI) of 40 to 45 kg/m2, or a BMI of 35 to 39.9 kg/m2 with one or more obesity related co-morbid conditions, and have failed at least one or more obesity related co-morbid conditions, and have failed at least one supervised weight management program within the past 5 years. Subsequent to this approval, the USPTO received a patent term restoration application for MAESTRO RECHARGEABLE SYSTEM (U.S. Patent No. 7,672,727) from EnteroMedics Inc., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated July 12, 2016, FDA advised the USPTO that this medical device had undergone a regulatory review period and that the approval of MAESTRO RECHARGEABLE SYSTEM 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 MAESTRO RECHARGEABLE SYSTEM is 2,866 days. Of this time, 2,296 days occurred during the testing phase of the regulatory review period, while 570 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 520(g) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(g)) involving this device became effective: March 13, 2007. The applicant claims that the investigational device exemption (IDE) required under section 520(g) of the FD&C Act for human tests to begin became effective on March 14, 2007. However, FDA records indicate that the IDE was determined substantially complete for clinical studies to have begun on March 13, 2007, which represents the IDE effective date. 2. The date an application was initially submitted with respect to the device under section 515 of the FD&C Act (21 U.S.C. 360e): June 24, 2013. The applicant claims June 20, 2013, as the date the premarket approval application (PMA) for MAESTRO RECHARGEABLE SYSTEM (PMA P130019) was initially submitted. However, FDA records indicate that PMA P130019 was submitted on June 24, 2013. 3. The date the application was approved: January 14, 2015. FDA has verified the applicant's claim that PMA P130019 was approved on January 14, 2015. 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 385 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. [[Page 7198]] Dated: February 13, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-03343 Filed 2-16-18; 8:45 am] BILLING CODE 4164-01-P
![7196 Federal Register / Vol. 83, No. 34 / Tuesday, February 20, 2018 / Notices
FDA will continue to rely on self- center, but also at the time that they In the Federal Register of November
certification by manufacturers for the submit the certification to the foreign 27, 2017 (82 FR 56031), FDA published
first three types of certificates listed in government. a 60-day notice requesting public
table 1. Manufacturers are requested to The appropriate FDA centers will comment on the proposed collection of
self-certify that they are in compliance review product information submitted information. No comments were
with all applicable requirements of the by firms in support of their certificate received. The burden hours have
FD&C Act, not only at the time that they and any suspected case of fraud will be decreased from the previous approval.
submit their request to the appropriate referred to the appropriate offices.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Total Average
Number of responses
FDA Center annual burden per Total hours
respondents per responses response
respondent
Center for Biologics Evaluation and Research .................... 2,651 1 2,651 1 2,651
Center for Devices and Radiological Health ....................... 11,175 1 11,175 2 22,350
Center for Drug Evaluation and Research .......................... 3,680 1 3,680 1 3,680
Center for Veterinary Medicine ............................................ 1,925 1 1,925 1 1,925
Total .............................................................................. ........................ ........................ ........................ ........................ 30,606
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: February 13, 2018. during the regulatory review period by • If you want to submit a comment
Leslie Kux, August 20, 2018. See ‘‘Petitions’’ in the with confidential information that you
Associate Commissioner for Policy. SUPPLEMENTARY INFORMATION section for do not wish to be made available to the
[FR Doc. 2018–03346 Filed 2–16–18; 8:45 am] more information. public, submit the comment as a
BILLING CODE 4164–01–P ADDRESSES: You may submit comments written/paper submission and in the
as follows. Please note that late, manner detailed (see ‘‘Written/Paper
untimely filed comments will not be Submissions’’ and ‘‘Instructions’’).
DEPARTMENT OF HEALTH AND considered. Electronic comments must Written/Paper Submissions
HUMAN SERVICES be submitted on or before April 23, Submit written/paper submissions as
2018. The https://www.regulations.gov follows:
Food and Drug Administration
electronic filing system will accept • Mail/Hand delivery/Courier (for
[Docket No. FDA–2016–E–1187] comments until midnight Eastern Time written/paper submissions): Dockets
at the end of April 23, 2018. Comments Management Staff (HFA–305), Food and
Determination of Regulatory Review received by mail/hand delivery/courier
Period for Purposes of Patent Drug Administration, 5630 Fishers
(for written/paper submissions) will be Lane, Rm. 1061, Rockville, MD 20852.
Extension; MAESTRO considered timely if they are
RECHARGEABLE SYSTEM • For written/paper comments
postmarked or the delivery service submitted to the Dockets Management
AGENCY: Food and Drug Administration, acceptance receipt is on or before that Staff, FDA will post your comment, as
HHS. date. well as any attachments, except for
ACTION: Notice. Electronic Submissions information submitted, marked and
identified, as confidential, if submitted
SUMMARY: The Food and Drug Submit electronic comments in the as detailed in ‘‘Instructions.’’
Administration (FDA or the Agency) has following way: Instructions: All submissions received
determined the regulatory review period • Federal eRulemaking Portal: must include the Docket No. FDA–
for MAESTRO RECHARGEABLE https://www.regulations.gov. Follow the 2016–E–1187 for ‘‘Determination of
SYSTEM and is publishing this notice instructions for submitting comments. Regulatory Review Period for Purposes
of that determination as required by Comments submitted electronically, of Patent Extension; MAESTRO
law. FDA has made the determination including attachments, to https:// RECHARGEABLE SYSTEM.’’ Received
because of the submission of an www.regulations.gov will be posted to comments, those filed in a timely
application to the Director of the U.S. the docket unchanged. Because your manner (see ADDRESSES), will be placed
Patent and Trademark Office (USPTO), comment will be made public, you are in the docket and, except for those
Department of Commerce, for the solely responsible for ensuring that your submitted as ‘‘Confidential
extension of a patent which claims that comment does not include any Submissions,’’ publicly viewable at
medical device. confidential information that you or a https://www.regulations.gov or at the
DATES: Anyone with knowledge that any third party may not wish to be posted, Dockets Management Staff between 9
of the dates as published (in the such as medical information, your or a.m. and 4 p.m., Monday through
SUPPLEMENTARY INFORMATION section) are anyone else’s Social Security number, or Friday.
sradovich on DSK3GMQ082PROD with NOTICES
incorrect may submit either electronic confidential business information, such • Confidential Submissions—To
or written comments and ask for a as a manufacturing process. Please note submit a comment with confidential
redetermination by April 23, 2018. that if you include your name, contact information that you do not wish to be
Furthermore, any interested person may information, or other information that made publicly available, submit your
petition FDA for a determination identifies you in the body of your comments only as a written/paper
regarding whether the applicant for comments, that information will be submission. You should submit two
extension acted with due diligence posted on https://www.regulations.gov. copies total. One copy will include the
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![7198 Federal Register / Vol. 83, No. 34 / Tuesday, February 20, 2018 / Notices
Dated: February 13, 2018. the docket unchanged. Because your https://www.regulations.gov. Submit
Leslie Kux, comment will be made public, you are both copies to the Dockets Management
Associate Commissioner for Policy. solely responsible for ensuring that your Staff. If you do not wish your name and
[FR Doc. 2018–03343 Filed 2–16–18; 8:45 am] comment does not include any contact information to be made publicly
BILLING CODE 4164–01–P confidential information that you or a available, you can provide this
third party may not wish to be posted, information on the cover sheet and not
such as medical information, your or in the body of your comments and you
DEPARTMENT OF HEALTH AND anyone else’s Social Security number, or must identify this information as
HUMAN SERVICES confidential business information, such ‘‘confidential.’’ Any information marked
as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed
Food and Drug Administration that if you include your name, contact except in accordance with 21 CFR 10.20
[Docket No. FDA–2009–N–0025] information, or other information that and other applicable disclosure law. For
identifies you in the body of your more information about FDA’s posting
Agency Information Collection comments, that information will be of comments to public dockets, see 80
Activities; Proposed Collection; posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access
Comment Request; Animal Food • If you want to submit a comment the information at: https://www.gpo.gov/
Labeling; Declaration of Certifiable with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015-
Color Additives do not wish to be made available to the 23389.pdf.
public, submit the comment as a Docket: For access to the docket to
AGENCY: Food and Drug Administration, written/paper submission and in the read background documents or the
HHS. manner detailed (see ‘‘Written/Paper electronic and written/paper comments
ACTION: Notice. Submissions’’ and ‘‘Instructions’’). received, go to https://
SUMMARY: The Food and Drug Written/Paper Submissions www.regulations.gov and insert the
Administration (FDA, Agency, or we) is docket number, found in brackets in the
Submit written/paper submissions as heading of this document, into the
announcing an opportunity for public follows: ‘‘Search’’ box and follow the prompts
comment on the proposed collection of • Mail/Hand delivery/Courier (for and/or go to the Dockets Management
certain information by the Agency. written/paper submissions): Dockets
Under the Paperwork Reduction Act of Staff, 5630 Fishers Lane, Rm. 1061,
Management Staff (HFA–305), Food and Rockville, MD 20852.
1995 (PRA), Federal Agencies are Drug Administration, 5630 Fishers
required to publish notice in the FOR FURTHER INFORMATION CONTACT: Ila
Lane, Rm. 1061, Rockville, MD 20852.
Federal Register concerning each • For written/paper comments S. Mizrachi, Office of Operations, Food
proposed collection of information, submitted to the Dockets Management and Drug Administration, Three White
including each proposed extension of an Staff, FDA will post your comment, as Flint North, 10A–12M, 11601
existing collection of information, and well as any attachments, except for Landsdown St., North Bethesda, MD
to allow 60 days for public comment in information submitted, marked and 20852, 301–796–7726, PRAStaff@
response to the notice. This notice identified, as confidential, if submitted fda.hhs.gov.
solicits comments on the information as detailed in ‘‘Instructions.’’ SUPPLEMENTARY INFORMATION: Under the
collection provisions of FDA regulations Instructions: All submissions received PRA (44 U.S.C. 3501–3520), Federal
requiring the declaration of color must include the Docket No. FDA– Agencies must obtain approval from the
additives on animal food labels. 2009–N–0025 for ‘‘Animal Food Office of Management and Budget
DATES: Submit either electronic or Labeling; Declaration of Certifiable (OMB) for each collection of
written comments on the collection of Color Additives.’’ Received comments, information they conduct or sponsor.
information by April 23, 2018. those filed in a timely manner (see ‘‘Collection of information’’ is defined
ADDRESSES: You may submit comments ADDRESSES), will be placed in the docket in 44 U.S.C. 3502(3) and 5 CFR
as follows. Please note that late, and, except for those submitted as 1320.3(c) and includes Agency requests
untimely filed comments will not be ‘‘Confidential Submissions,’’ publicly or requirements that members of the
considered. Electronic comments must viewable at https://www.regulations.gov public submit reports, keep records, or
be submitted on or before April 23, or at the Dockets Management Staff provide information to a third party.
2018. The https://www.regulations.gov between 9 a.m. and 4 p.m., Monday Section 3506(c)(2)(A) of the PRA (44
electronic filing system will accept through Friday. U.S.C. 3506(c)(2)(A)) requires Federal
comments until midnight Eastern Time • Confidential Submissions—To Agencies to provide a 60-day notice in
at the end of April 23, 2018. Comments submit a comment with confidential the Federal Register concerning each
received by mail/hand delivery/courier information that you do not wish to be proposed collection of information,
(for written/paper submissions) will be made publicly available, submit your including each proposed extension of an
considered timely if they are comments only as a written/paper existing collection of information,
postmarked or the delivery service submission. You should submit two before submitting the collection to OMB
acceptance receipt is on or before that copies total. One copy will include the for approval. To comply with this
date. information you claim to be confidential requirement, FDA is publishing notice
with a heading or cover note that states of the proposed collection of
Electronic Submissions ‘‘THIS DOCUMENT CONTAINS information set forth in this document.
CONFIDENTIAL INFORMATION.’’ The With respect to the following
sradovich on DSK3GMQ082PROD with NOTICES
Submit electronic comments in the
following way: Agency will review this copy, including collection of information, FDA invites
• Federal eRulemaking Portal: the claimed confidential information, in comments on these topics: (1) Whether
https://www.regulations.gov. Follow the its consideration of comments. The the proposed collection of information
instructions for submitting comments. second copy, which will have the is necessary for the proper performance
Comments submitted electronically, claimed confidential information of FDA’s functions, including whether
including attachments, to https:// redacted/blacked out, will be available the information will have practical
www.regulations.gov will be posted to for public viewing and posted on utility; (2) the accuracy of FDA’s
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Document Created: 2018-02-17 02:29:21
Document Modified: 2018-02-17 02:29:21
| 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 April 23, 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 August 20, 2018. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information. | |
| Contact | Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600. | |
| FR Citation | 83 FR 7196 |
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