83 FR 6034 - Determination of Regulatory Review Period for Purposes of Patent Extension; BELSOMRA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 29 (February 12, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 29 (February 12, 2018)
| Page Range | 6034-6036 | |
| FR Document | 2018-02763 |
[Federal Register Volume 83, Number 29 (Monday, February 12, 2018)] [Notices] [Pages 6034-6036] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-02763] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-E-2725] Determination of Regulatory Review Period for Purposes of Patent Extension; BELSOMRA 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 BELSOMRA 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 (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by April 13, 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 13, 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 13, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 13, 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 [[Page 6035]] 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-2015-E-2725 for ``Determination of Regulatory Review Period for Purposes of Patent Extension; BELSOMRA.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with Sec. 10.20 (21 CFR 10.20) and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600. SUPPLEMENTARY INFORMATION: I. Background The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human 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 BELSOMRA (suvorexant). BELSOMRA is indicated for treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. Subsequent to this approval, the USPTO received a patent term restoration application for BELSOMRA (U.S. Patent No. 7,951,797) from Merck Sharp & Dohme Corp., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated October 15, 2015, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of BELSOMRA 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 BELSOMRA is 2,291 days. Of this time, 1,577 days occurred during the testing phase of the regulatory review period, while 714 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 (FD&C Act) (21 U.S.C. 355(i)) became effective: May 7, 2008. The applicant claims May 10, 2008, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was May 7, 2008, which was the date FDA notified the applicant that the IND studies may proceed. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: August 30, 2012. FDA has verified the applicant's claim that the new drug application (NDA) for BELSOMRA (NDA 204569) [[Page 6036]] was initially submitted on August 30, 2012. 3. The date the application was approved: August 13, 2014. FDA has verified the applicant's claim that NDA 204569 was approved on August 13, 2014. 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 zero days of patent term extension. III. Petitions Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in Sec. 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of Sec. 60.30, including but not limited to: Must be timely (see DATES), must be filed in accordance with Sec. 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: February 7, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-02763 Filed 2-9-18; 8:45 am] BILLING CODE 4164-01-P
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U.S.C. 360b(j)) became effective and new animal drug application (INAD) Dated: February 7, 2018.
runs until the approval phase begins. became effective. However, FDA records Leslie Kux,
The approval phase starts with the indicate that the INAD effective date Associate Commissioner for Policy.
initial submission of an application to was August 4, 2011, which was the date [FR Doc. 2018–02761 Filed 2–9–18; 8:45 am]
market the animal drug product and a major health or environmental effects BILLING CODE 4164–01–P
continues until FDA grants permission test was begun or the date on which the
to market the drug product. Although Agency acknowledged the filing of a
only a portion of a regulatory review notice of claimed investigational DEPARTMENT OF HEALTH AND
period may count toward the actual exemption for a new animal drug, HUMAN SERVICES
amount of extension that the Director of whichever was earlier.
USPTO may award (for example, half Food and Drug Administration
the testing phase must be subtracted as 2. The date the application was
initially submitted with respect to the [Docket No. FDA–2015–E–2725]
well as any time that may have occurred
before the patent was issued), FDA’s animal drug product under section 512
of the FD&C Act: April 8, 2014. FDA has Determination of Regulatory Review
determination of the length of a Period for Purposes of Patent
regulatory review period for an animal verified the applicant’s claim that the
Extension; BELSOMRA
drug product will include all of the new animal drug application (NADA)
testing phase and approval phase as for BRAVECTO (NADA 141–426) was AGENCY: Food and Drug Administration,
specified in 35 U.S.C. 156(g)(4)(B). submitted on April 8, 2014. HHS.
FDA has approved for marketing the 3. The date the application was ACTION: Notice.
animal drug product BRAVECTO approved: May 15, 2014. FDA has
(fluralaner). BRAVECTO is indicated for SUMMARY: The Food and Drug
verified the applicant’s claim that Administration (FDA or the Agency) has
treatment and control of flea infestations NADA 141–426 was approved on May
(Ctenocephalides felis), and the determined the regulatory review period
15, 2014. for BELSOMRA and is publishing this
treatment and control of tick
This determination of the regulatory notice of that determination as required
infestations (Ixodes scapularis (black
review period establishes the maximum by law. FDA has made the
legged tick), Dermacentor variabilis
(American dog tick), and Rhipicephalus potential length of a patent extension. determination because of the
sanguineus (brown dog tick)) for 12 However, the USPTO applies several submission of an application to the
weeks in dogs and puppies 6 months of statutory limitations in its calculations Director of the U.S. Patent and
age and older, and weighing 4.4 pounds of the actual period for patent extension. Trademark Office (USPTO), Department
or greater. It is also indicated for the In its application for patent extension, of Commerce, for the extension of a
treatment and control of Amblyomma this applicant seeks 792 days of patent patent which claims that human drug
americanum (lone star tick) infestations term extension. product.
for 8 weeks in dogs and puppies 6 DATES: Anyone with knowledge that any
III. Petitions
months of age and older and weighing of the dates as published (see the
4.4 pounds or greater. Subsequent to Anyone with knowledge that any of SUPPLEMENTARY INFORMATION section) are
this approval, the USPTO received a the dates as published are incorrect may incorrect may submit either electronic
patent term restoration application for submit either electronic or written or written comments and ask for a
BRAVECTO (U.S. Patent No. 7,662,972) comments and, under 21 CFR 60.24, ask redetermination by April 13, 2018.
from Nissan Chemical Industries, Ltd., for a redetermination (see DATES). Furthermore, any interested person may
and the USPTO requested FDA’s Furthermore, as specified in § 60.30 (21 petition FDA for a determination
assistance in determining this patent’s CFR 60.30), any interested person may regarding whether the applicant for
eligibility for patent term restoration. In petition FDA for a determination extension acted with due diligence
a letter dated October 19, 2015, FDA regarding whether the applicant for during the regulatory review period by
advised the USPTO that this animal extension acted with due diligence August 13, 2018. See ‘‘Petitions’’ in the
drug product had undergone a during the regulatory review period. To SUPPLEMENTARY INFORMATION section for
regulatory review period and that the meet its burden, the petition must more information.
approval of BRAVECTO represented the comply with all the requirements of ADDRESSES: You may submit comments
first permitted commercial marketing or § 60.30, including but not limited to: as follows. Please note that late,
use of the product. Thereafter, the Must be timely (see DATES), must be untimely filed comments will not be
USPTO requested that FDA determine filed in accordance with § 10.20, must considered. Electronic comments must
the product’s regulatory review period. contain sufficient facts to merit an FDA be submitted on or before April 13,
investigation, and must certify that a 2018. The https://www.regulations.gov
II. Determination of Regulatory Review
true and complete copy of the petition electronic filing system will accept
Period
has been served upon the patent comments until midnight Eastern Time
FDA has determined that the at the end of April 13, 2018. Comments
applicant. (See H. Rept. 857, part 1, 98th
applicable regulatory review period for received by mail/hand delivery/courier
Cong., 2d sess., pp. 41–42, 1984.)
BRAVECTO is 1,017 days. Of this time, (for written/paper submissions) will be
Petitions should be in the format
979 days occurred during the testing considered timely if they are
specified in 21 CFR 10.30.
phase of the regulatory review period, postmarked or the delivery service
while 38 days occurred during the Submit petitions electronically to acceptance receipt is on or before that
daltland on DSKBBV9HB2PROD with NOTICES
approval phase. These periods of time https://www.regulations.gov at Docket date.
were derived from the following dates: No. FDA–2013–S–0610. Submit written
1. The date an exemption under petitions (two copies are required) to the Electronic Submissions
section 505(i) of the FD&C Act (21 Dockets Management Staff (HFA–305), Submit electronic comments in the
U.S.C. 355(i)) became effective: August Food and Drug Administration, 5630 following way:
4, 2011. The applicant claims February Fishers Lane, Rm. 1061, Rockville, MD • Federal eRulemaking Portal:
19, 2010, as the date the investigational 20852. https://www.regulations.gov. Follow the
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![6036 Federal Register / Vol. 83, No. 29 / Monday, February 12, 2018 / Notices
was initially submitted on August 30, DEPARTMENT OF HEALTH AND rule entitled ‘‘Content and Format of
2012. HUMAN SERVICES Labeling for Human Prescription Drug
3. The date the application was and Biological Products; Requirements
Food and Drug Administration for Pregnancy and Lactation Labeling.’’
approved: August 13, 2014. FDA has
[Docket No. FDA–2017–N–5624] The final rule amended FDA regulations
verified the applicant’s claim that NDA
concerning the content and format of
204569 was approved on August 13,
Agency Information Collection the ‘‘Pregnancy,’’ ‘‘Labor and delivery,’’
2014. and ‘‘Nursing mothers’’ subsections of
Activities; Submission for Office of
This determination of the regulatory Management and Budget Review; the ‘‘Use in Specific Populations’’
review period establishes the maximum Comment Request; Content and section of the labeling for human
potential length of a patent extension. Format of Labeling for Human prescription drugs. The regulations now
However, the USPTO applies several Prescription Drugs and Biological require, among other things, a summary
statutory limitations in its calculations Products; Requirements for Pregnancy of the risks of using a drug during
of the actual period for patent extension. and Lactation Labeling pregnancy and lactation and a
In its application for patent extension, discussion of the data supporting that
this applicant seeks zero days of patent AGENCY: Food and Drug Administration, summary. The labeling must also
term extension. HHS. include relevant information to help
ACTION: Notice. health care providers make prescribing
III. Petitions decisions and counsel women about the
SUMMARY: The Food and Drug use of drugs during pregnancy and
Anyone with knowledge that any of Administration (FDA) is announcing lactation. The final rule eliminated the
the dates as published are incorrect may that a proposed collection of pregnancy categories A, B, C, D, and X.
submit either electronic or written information has been submitted to the In addition, FDA eliminated the ‘‘Labor
comments and, under 21 CFR 60.24, ask Office of Management and Budget and delivery’’ subsection because the
for a redetermination (see DATES). (OMB) for review and clearance under ‘‘Pregnancy’’ subsection includes
Furthermore, as specified in § 60.30 (21 the Paperwork Reduction Act of 1995. information on labor and delivery. The
CFR 60.30), any interested person may DATES: Fax written comments on the final rule also required that the labeling
petition FDA for a determination collection of information by March 14, include relevant information about
regarding whether the applicant for 2018. pregnancy testing, contraception, and
extension acted with due diligence ADDRESSES: To ensure that comments on infertility for health care providers
during the regulatory review period. To the information collection are received, prescribing for females and males of
meet its burden, the petition must OMB recommends that written reproductive potential. In addition, the
comply with all the requirements of comments be faxed to the Office of final rule provided for a 10-year
§ 60.30, including but not limited to: Information and Regulatory Affairs, implementation schedule for
Must be timely (see DATES), must be OMB, Attn: FDA Desk Officer, Fax: 202– compliance with the relevant
filed in accordance with § 10.20, must 395–7285, or emailed to oira_ regulations. As the implementation
contain sufficient facts to merit an FDA submission@omb.eop.gov. All schedule is realized, FDA plans to
comments should be identified with the discontinue this separate information
investigation, and must certify that a
OMB control number 0910–0624. Also collection and incorporate the
true and complete copy of the petition
include the FDA docket number found provisions into existing collections as
has been served upon the patent
in brackets in the heading of this appropriate.
applicant. (See H. Rept. 857, part 1, 98th The content and format requirements
Cong., 2d sess., pp. 41–42, 1984.) document.
apply to:
Petitions should be in the format FOR FURTHER INFORMATION CONTACT: • Applications submitted on or after
specified in 21 CFR 10.30. Domini Bean, Office of Operations, June 30, 2015 (§§ 314.50 (21 CFR
Submit petitions electronically to Food and Drug Administration, Three 314.50), 314.70(b) (21 CFR 314.70(b)),
https://www.regulations.gov at Docket White Flint North, 10A–12M, 11601 601.2 (21 CFR 601.2), and 601.12(f)(1))
No. FDA–2013–S–0610. Submit written Landsdown St., North Bethesda, MD (21 CFR 601.12(f)(1));
petitions (two copies are required) to the 20852, 301–796–5733, PRAStaff@ • amendments to applications
fda.hhs.gov. pending on June 30, 2015 (§§ 314.60 (21
Dockets Management Staff (HFA–305),
SUPPLEMENTARY INFORMATION: In CFR 314.60), 601.2, and 601.12(f)(1));
Food and Drug Administration, 5630
compliance with 44 U.S.C. 3507, FDA • supplements to applications
Fishers Lane, Rm. 1061, Rockville, MD approved from June 30, 2001, to June
20852. has submitted the following proposed
collection of information to OMB for 30, 2015 (§§ 314.70(b) and 601.12(f)(1));
Dated: February 7, 2018.
review and clearance. and
Leslie Kux, • annual reports for applications
Associate Commissioner for Policy.
Content and Format of Labeling for approved before June 30, 2001, that
Human Prescription Drugs and contain a pregnancy category, to report
[FR Doc. 2018–02763 Filed 2–9–18; 8:45 am]
Biological Products; Requirements for removal of the pregnancy category letter
BILLING CODE 4164–01–P Pregnancy and Lactation Labeling in their labeling (§§ 314.70(d) and
601.12(f)(3)).
OMB Control Number 0910–0624— Under § 201.57(c)(9)(i) and (ii) (21
daltland on DSKBBV9HB2PROD with NOTICES
Extension CFR 201.57(c)(9)(i) and (ii)), holders of
This information collection supports approved applications must provide
Agency regulations regarding the new labeling content in a new format—
content and format requirements for that is, to rewrite the pregnancy and
pregnancy and lactation labeling. In the lactation portions of each drug’s
Federal Register of December 4, 2014 labeling. Section 201.57(c)(9)(iii)
(79 FR 72064), FDA published a final requires that labeling must include the
VerDate Sep<11>2014 19:23 Feb 09, 2018 Jkt 244001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\12FEN1.SGM 12FEN1](https://thefederalregister.org/doc/83_FR_6063/page/3.svg)
Document Created: 2018-11-01 08:43:26
Document Modified: 2018-11-01 08:43:26
| 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 April 13, 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 13, 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 6034 |
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