83 FR 7056 - Migraine: Developing Drugs for Acute Treatment; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 33 (February 16, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 33 (February 16, 2018)
| Page Range | 7056-7057 | |
| FR Document | 2018-03224 |
[Federal Register Volume 83, Number 33 (Friday, February 16, 2018)] [Notices] [Pages 7056-7057] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-03224] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-D-1540] Migraine: Developing Drugs for Acute Treatment; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Migraine: Developing Drugs for Acute Treatment.'' The purpose of this guidance is to assist sponsors in the clinical development of prescription drugs for the acute treatment of migraine. This guidance focuses on specific drug development and trial design issues that are unique to the study of prescription drugs for the acute treatment of migraine. This guidance finalizes the draft guidance of the same name issued October 22, 2014. DATES: The announcement of the guidance is published in the Federal Register on February 16, 2018. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: 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-2014-D-1540 for ``Migraine: Developing Drugs for Acute Treatment; Guidance for Industry; Availability.'' Received comments 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 [[Page 7057]] ``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 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. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self- addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Eric Bastings, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4334, Silver Spring, MD 20993-0002, 301- 796-1039. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ``Migraine: Developing Drugs for Acute Treatment.'' The purpose of this guidance is to assist sponsors in the clinical development of prescription drugs for the acute treatment of migraine. This guidance focuses on specific drug development and trial design issues that are unique to the study of prescription drugs for the acute treatment of migraine, including trial population, trial design, dose selection, efficacy endpoints, and statistical considerations. The guidance also discusses safety considerations, pediatric studies, and labeling considerations. This guidance finalizes the draft guidance of the same name issued October 22, 2014 (79 FR 63129). It reflects FDA's consideration of public comments on the draft guidance and makes minor clarifying changes. This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on developing drugs for the acute treatment of migraine. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866. II. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR parts 201, 312, and 314 have been approved under OMB control numbers 0910-0572, 0910-0014, and 0910-0001, respectively. III. Electronic Access Persons with access to the internet may obtain the guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Dated: February 12, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-03224 Filed 2-15-18; 8:45 am] BILLING CODE 4164-01-P
![7056 Federal Register / Vol. 83, No. 33 / Friday, February 16, 2018 / Notices
in combination with vemurafenib. extension acted with due diligence Electronic Submissions
Subsequent to this approval, the USPTO during the regulatory review period. To Submit electronic comments in the
received patent term restoration meet its burden, the petition must following way:
applications for COTELLIC (U.S. Patent comply with all the requirements of • Federal eRulemaking Portal:
Nos. 7,803,839 and 8,362,002) from § 60.30, including but not limited to: https://www.regulations.gov. Follow the
Exelixis, Inc., and the USPTO requested Must be timely (see DATES), must be instructions for submitting comments.
FDA’s assistance in determining the filed in accordance with § 10.20, must Comments submitted electronically,
patents’ eligibility for patent term contain sufficient facts to merit an FDA including attachments, to https://
restoration. In a letter dated September investigation, and must certify that a www.regulations.gov will be posted to
26, 2016, FDA advised the USPTO that true and complete copy of the petition the docket unchanged. Because your
this human drug product had undergone has been served upon the patent comment will be made public, you are
a regulatory review period and that the applicant. (See H. Rept. 857, part 1, 98th solely responsible for ensuring that your
approval of COTELLIC represented the Cong., 2d sess., pp. 41–42, 1984.) comment does not include any
first permitted commercial marketing or Petitions should be in the format confidential information that you or a
use of the product. Thereafter, the specified in 21 CFR 10.30. third party may not wish to be posted,
USPTO requested that FDA determine Submit petitions electronically to such as medical information, your or
the product’s regulatory review period. https://www.regulations.gov at Docket anyone else’s Social Security number, or
II. Determination of Regulatory Review No. FDA–2013–S–0610. Submit written confidential business information, such
Period petitions (two copies are required) to the as a manufacturing process. Please note
Dockets Management Staff (HFA–305), that if you include your name, contact
FDA has determined that the Food and Drug Administration, 5630
applicable regulatory review period for information, or other information that
Fishers Lane, Rm. 1061, Rockville, MD identifies you in the body of your
COTELLIC is 3,219 days. Of this time, 20852.
2,884 days occurred during the testing comments, that information will be
phase of the regulatory review period, Dated: February 12, 2018. posted on https://www.regulations.gov.
while 335 days occurred during the Leslie Kux, • If you want to submit a comment
approval phase. These periods of time Associate Commissioner for Policy. with confidential information that you
were derived from the following dates: [FR Doc. 2018–03218 Filed 2–15–18; 8:45 am] do not wish to be made available to the
1. The date an exemption under BILLING CODE 4164–01–P
public, submit the comment as a
section 505(i) of the Federal Food, Drug, written/paper submission and in the
and Cosmetic Act (FD&C Act) (21 U.S.C. manner detailed (see ‘‘Written/Paper
355(i)) became effective: January 19, DEPARTMENT OF HEALTH AND Submissions’’ and ‘‘Instructions’’).
2007. FDA has verified the Exelixis, Inc. HUMAN SERVICES Written/Paper Submissions
claim that January 19, 2007, is the date
the investigational new drug application Food and Drug Administration Submit written/paper submissions as
became effective. follows:
2. The date the application was [Docket No. FDA–2014–D–1540] • Mail/Hand delivery/Courier (for
initially submitted with respect to the written/paper submissions): Dockets
human drug product under section 505 Migraine: Developing Drugs for Acute Management Staff (HFA–305), Food and
of the FD&C Act: December 11, 2014. Treatment; Guidance for Industry; Drug Administration, 5630 Fishers
FDA has verified the applicant’s claim Availability Lane, Rm. 1061, Rockville, MD 20852.
that the new drug application (NDA) for • For written/paper comments
AGENCY: Food and Drug Administration, submitted to the Dockets Management
COTELLIC (NDA 206192) was initially HHS.
submitted on December 11, 2014. Staff, FDA will post your comment, as
3. The date the application was ACTION: Notice of availability. well as any attachments, except for
approved: November 10, 2015. FDA has information submitted, marked and
SUMMARY: The Food and Drug identified, as confidential, if submitted
verified the applicant’s claim that NDA Administration (FDA or Agency) is
206192 was approved on November 10, as detailed in ‘‘Instructions.’’
announcing the availability of a Instructions: All submissions received
2015. guidance for industry entitled
This determination of the regulatory must include the Docket No. FDA–
‘‘Migraine: Developing Drugs for Acute 2014–D–1540 for ‘‘Migraine: Developing
review period establishes the maximum Treatment.’’ The purpose of this
potential length of a patent extension. Drugs for Acute Treatment; Guidance
guidance is to assist sponsors in the for Industry; Availability.’’ Received
However, the USPTO applies several clinical development of prescription
statutory limitations in its calculations comments will be placed in the docket
drugs for the acute treatment of and, except for those submitted as
of the actual period for patent extension. migraine. This guidance focuses on
In its applications for patent extension, ‘‘Confidential Submissions,’’ publicly
specific drug development and trial viewable at https://www.regulations.gov
this applicant seeks 1,013 days or 676 design issues that are unique to the
days of patent term extension. or at the Dockets Management Staff
study of prescription drugs for the acute between 9 a.m. and 4 p.m., Monday
III. Petitions treatment of migraine. This guidance through Friday.
Anyone with knowledge that any of finalizes the draft guidance of the same • Confidential Submissions—To
the dates as published are incorrect may name issued October 22, 2014. submit a comment with confidential
daltland on DSKBBV9HB2PROD with NOTICES
submit either electronic or written DATES: The announcement of the information that you do not wish to be
comments and, under 21 CFR 60.24, ask guidance is published in the Federal made publicly available, submit your
for a redetermination (see DATES). Register on February 16, 2018. comments only as a written/paper
Furthermore, as specified in § 60.30 (21 ADDRESSES: You may submit either submission. You should submit two
CFR 60.30), any interested person may electronic or written comments on copies total. One copy will include the
petition FDA for a determination Agency guidances at any time as information you claim to be confidential
regarding whether the applicant for follows: with a heading or cover note that states
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![Federal Register / Vol. 83, No. 33 / Friday, February 16, 2018 / Notices 7057
‘‘THIS DOCUMENT CONTAINS drugs for the acute treatment of DEPARTMENT OF HEALTH AND
CONFIDENTIAL INFORMATION.’’ The migraine. This guidance focuses on HUMAN SERVICES
Agency will review this copy, including specific drug development and trial
the claimed confidential information, in design issues that are unique to the Food and Drug Administration
its consideration of comments. The study of prescription drugs for the acute [Docket No. FDA–2018–D–0178]
second copy, which will have the treatment of migraine, including trial
claimed confidential information population, trial design, dose selection, Drugs for Treatment of Partial Onset
redacted/blacked out, will be available efficacy endpoints, and statistical Seizures: Full Extrapolation of Efficacy
for public viewing and posted on considerations. The guidance also From Adults to Pediatric Patients 4
https://www.regulations.gov. Submit discusses safety considerations, Years of Age and Older; Draft
both copies to the Dockets Management pediatric studies, and labeling Guidance for Industry; Availability
Staff. If you do not wish your name and considerations.
contact information to be made publicly AGENCY: Food and Drug Administration,
available, you can provide this This guidance finalizes the draft HHS.
information on the cover sheet and not guidance of the same name issued ACTION: Notice of availability.
in the body of your comments and you October 22, 2014 (79 FR 63129). It
SUMMARY: The Food and Drug
must identify this information as reflects FDA’s consideration of public Administration (FDA or Agency) is
‘‘confidential.’’ Any information marked comments on the draft guidance and announcing the availability of a draft
as ‘‘confidential’’ will not be disclosed makes minor clarifying changes. guidance for industry entitled ‘‘Drugs
except in accordance with 21 CFR 10.20 This guidance is being issued for Treatment of Partial Onset Seizures:
and other applicable disclosure law. For consistent with FDA’s good guidance Full Extrapolation of Efficacy from
more information about FDA’s posting practices regulation (21 CFR 10.115). Adults to Pediatric Patients 4 Years of
of comments to public dockets, see 80 The guidance represents the current Age and Older.’’ The draft guidance
FR 56469, September 18, 2015, or access thinking of FDA on developing drugs for provides recommendations to sponsors
the information at: https://www.gpo.gov/ on the clinical development of drugs for
the acute treatment of migraine. It does
fdsys/pkg/FR-2015-09-18/pdf/2015- the treatment of partial onset seizures
not establish any rights for any person
23389.pdf. (POS) in pediatric patients. Specifically,
Docket: For access to the docket to and is not binding on FDA or the public.
You can use an alternative approach if it addresses FDA’s thinking regarding
read background documents or the clinical development programs that can
electronic and written/paper comments it satisfies the requirements of the
applicable statutes and regulations. This support extrapolation of evidence of
received, go to https:// effectiveness in treatment of POS in
www.regulations.gov and insert the guidance is not subject to Executive
adults to pediatric patients 4 years of
docket number, found in brackets in the Order 12866.
age and older.
heading of this document, into the II. Paperwork Reduction Act of 1995 DATES: Submit either electronic or
‘‘Search’’ box and follow the prompts
written comments on the draft guidance
and/or go to the Dockets Management This guidance refers to previously by April 17, 2018 to ensure that the
Staff, 5630 Fishers Lane, Rm. 1061, approved collections of information Agency considers your comment on this
Rockville, MD 20852. found in FDA regulations. These draft guidance before it begins work on
You may submit comments on any collections of information are subject to the final version of the guidance.
guidance at any time (see 21 CFR review by the Office of Management and ADDRESSES: You may submit comments
10.115(g)(5)). Budget (OMB) under the Paperwork
Submit written requests for single on any guidance at any time as follows:
Reduction Act of 1995 (44 U.S.C. 3501–
copies of this guidance to the Division 3520). The collections of information in Electronic Submissions
of Drug Information, Center for Drug Submit electronic comments in the
21 CFR parts 201, 312, and 314 have
Evaluation and Research, Food and following way:
been approved under OMB control
Drug Administration, 10001 New • Federal eRulemaking Portal:
numbers 0910–0572, 0910–0014, and
Hampshire Ave., Hillandale Building, https://www.regulations.gov. Follow the
4th Floor, Silver Spring, MD 20993– 0910–0001, respectively.
instructions for submitting comments.
0002. Send one self-addressed adhesive III. Electronic Access Comments submitted electronically,
label to assist that office in processing including attachments, to https://
your requests. See the SUPPLEMENTARY Persons with access to the internet
www.regulations.gov will be posted to
INFORMATION section for electronic may obtain the guidance at either the docket unchanged. Because your
access to the guidance document. https://www.fda.gov/Drugs/Guidance comment will be made public, you are
FOR FURTHER INFORMATION CONTACT: Eric ComplianceRegulatoryInformation/ solely responsible for ensuring that your
Bastings, Center for Drug Evaluation and Guidances/default.htm or https:// comment does not include any
Research, Food and Drug www.regulations.gov. confidential information that you or a
Administration, 10903 New Hampshire Dated: February 12, 2018. third party may not wish to be posted,
Ave., Bldg. 22, Rm. 4334, Silver Spring, Leslie Kux, such as medical information, your or
MD 20993–0002, 301–796–1039. anyone else’s Social Security number, or
Associate Commissioner for Policy.
SUPPLEMENTARY INFORMATION: confidential business information, such
[FR Doc. 2018–03224 Filed 2–15–18; 8:45 am]
as a manufacturing process. Please note
daltland on DSKBBV9HB2PROD with NOTICES
I. Background BILLING CODE 4164–01–P that if you include your name, contact
FDA is announcing the availability of information, or other information that
a guidance for industry entitled identifies you in the body of your
‘‘Migraine: Developing Drugs for Acute comments, that information will be
Treatment.’’ The purpose of this posted on https://www.regulations.gov.
guidance is to assist sponsors in the • If you want to submit a comment
clinical development of prescription with confidential information that you
VerDate Sep<11>2014 19:24 Feb 15, 2018 Jkt 244001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\16FEN1.SGM 16FEN1](https://thefederalregister.org/doc/83_FR_7089/page/2.svg)
Document Created: 2018-02-16 00:55:45
Document Modified: 2018-02-16 00:55:45
| 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 of availability. | |
| Dates | The announcement of the guidance is published in the Federal Register on February 16, 2018. | |
| Contact | Eric Bastings, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4334, Silver Spring, MD 20993-0002, 301- 796-1039. | |
| FR Citation | 83 FR 7056 |
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