83 FR 28851 - Major Depressive Disorder: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 120 (June 21, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 120 (June 21, 2018)
| Page Range | 28851-28853 | |
| FR Document | 2018-13297 |
[Federal Register Volume 83, Number 120 (Thursday, June 21, 2018)] [Notices] [Pages 28851-28853] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-13297] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-1919] Major Depressive Disorder: Developing Drugs for Treatment; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Major Depressive Disorder: Developing Drugs for Treatment.'' The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the monotherapeutic, combination, and adjunctive treatment of major depressive disorder (MDD). Specifically, this draft guidance addresses FDA's current thinking regarding the overall development program and clinical trial designs for antidepressant drug products. This draft guidance is intended to serve as a focus for continued discussions among FDA, pharmaceutical sponsors, the academic community, and the public. This draft [[Page 28852]] guidance revises the guidance for industry entitled ``Guidelines for the Clinical Evaluation of Antidepressant Drugs'' issued in September 1977. DATES: Submit either electronic or written comments on the draft guidance by August 20, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance 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-2018-D-1919 for ``Major Depressive Disorder: Developing Drugs for Treatment; Draft Guidance for Industry.'' 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 ``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 the draft 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 draft guidance document. FOR FURTHER INFORMATION CONTACT: Juliette Tour[eacute], Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4120, Silver Spring, MD 20993-0002, 301- 796-2260. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``Major Depressive Disorder: Developing Drugs for Treatment.'' The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the monotherapeutic, combination, and adjunctive treatment of MDD. Specifically, this draft guidance addresses FDA's current thinking regarding the overall development program and clinical trial designs for antidepressant drug products. This draft guidance is intended to serve as a focus for continued discussions among FDA, pharmaceutical sponsors, the academic community, and the public. This draft guidance revises the guidance for industry entitled ``Guidelines for the Clinical Evaluation of Antidepressant Drugs'' issued in September 1977. Major revisions were made to the 1977 guidance to align it with the FDA's current thinking on this topic. This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on developing drugs for the treatment of MDD. 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. The Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information that 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 312 and 314 have been approved under OMB control numbers 0910-0014 and 0910-0001, respectively. III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. [[Page 28853]] Dated: June 15, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-13297 Filed 6-20-18; 8:45 am] BILLING CODE 4164-01-P
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comments, those filed in a timely modifications that impact a previously Persons attending FDA’s advisory
manner (see ADDRESSES), will be placed announced advisory committee meeting committee meetings are advised that
in the docket and, except for those cannot always be published quickly FDA is not responsible for providing
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Submissions,’’ publicly viewable at Therefore, you should always check the For press inquiries, please contact the
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information that you do not wish to be before coming to the meeting. If you require accommodations due to a
made publicly available, submit your SUPPLEMENTARY INFORMATION: disability, please contact Lauren Tesh
comments only as a written/paper Agenda: The committee will discuss (see FOR FURTHER INFORMATION CONTACT)
submission. You should submit two new drug applications 209816, for at least 7 days in advance of the
copies total. One copy will include the omadacycline tablets, and 209817, for meeting.
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confidential information redacted/ than 2 business days before the meeting. Notice of this meeting is given under
blacked out, will be available for public If FDA is unable to post the background the Federal Advisory Committee Act (5
viewing and posted on https:// material on its website prior to the U.S.C. app. 2).
www.regulations.gov. Submit both meeting, the background material will Dated: June 15, 2018.
copies to the Dockets Management Staff. be made publicly available at the Leslie Kux,
If you do not wish your name and location of the advisory committee Associate Commissioner for Policy.
contact information be made publicly meeting, and the background material [FR Doc. 2018–13296 Filed 6–20–18; 8:45 am]
available, you can provide this will be posted on FDA’s website after
information on the cover sheet and not BILLING CODE 4164–01–P
the meeting. Background material is
in the body of your comments and you available at https://www.fda.gov/
must identify the information as AdvisoryCommittees/Calendar/ DEPARTMENT OF HEALTH AND
‘‘confidential.’’ Any information marked default.htm. Scroll down to the HUMAN SERVICES
as ‘‘confidential’’ will not be disclosed appropriate advisory committee meeting
except in accordance with 21 CFR 10.20 link. Food and Drug Administration
and other applicable disclosure law. For Procedure: Interested persons may
more information about FDA’s posting present data, information, or views, [Docket No. FDA–2018–D–1919]
of comments to public dockets, see 80 orally or in writing, on issues pending
FR 56469, September 18, 2015, or access Major Depressive Disorder: Developing
before the committee. All electronic and
the information at: https://www.gpo.gov/ Drugs for Treatment; Draft Guidance
written submissions submitted to the
fdsys/pkg/FR-2015-09-18/pdf/2015- for Industry; Availability
Docket (see ADDRESSES) on or before
23389.pdf. July 24, 2018, will be provided to the AGENCY: Food and Drug Administration,
Docket: For access to the docket to committee. Oral presentations from the HHS.
read background documents or the public will be scheduled between ACTION: Notice of availability.
electronic and written/paper comments approximately 11 a.m. and 12 noon.
received, go to https:// Those individuals interested in making SUMMARY: The Food and Drug
www.regulations.gov and insert the formal oral presentations should notify Administration (FDA or Agency) is
docket number, found in brackets in the the contact person and submit a brief announcing the availability of a draft
heading of this document, into the statement of the general nature of the guidance for industry entitled ‘‘Major
‘‘Search’’ box and follow the prompts evidence or arguments they wish to Depressive Disorder: Developing Drugs
and/or go to the Dockets Management present, the names and addresses of for Treatment.’’ The purpose of this
Staff, 5630 Fishers Lane, Rm. 1061, proposed participants, and an draft guidance is to assist sponsors in
Rockville, MD 20852. indication of the approximate time the clinical development of drugs for
FOR FURTHER INFORMATION CONTACT: requested to make their presentation on the monotherapeutic, combination, and
Lauren D. Tesh, Center for Drug or before July 16, 2018. Time allotted for adjunctive treatment of major
Evaluation and Research, Food and each presentation may be limited. If the depressive disorder (MDD). Specifically,
Drug Administration, 10903 New number of registrants requesting to this draft guidance addresses FDA’s
Hampshire Ave., Bldg. 31, Rm. 2417, speak is greater than can be reasonably current thinking regarding the overall
amozie on DSK3GDR082PROD with NOTICES1
Silver Spring, MD 20993–0002, 301– accommodated during the scheduled development program and clinical trial
796–9001, Fax: 301–847–8533, email: open public hearing session, FDA may designs for antidepressant drug
AMDAC@fda.hhs.gov, or FDA Advisory conduct a lottery to determine the products. This draft guidance is
Committee Information Line, 1–800– speakers for the scheduled open public intended to serve as a focus for
741–8138 (301–443–0572 in the hearing session. The contact person will continued discussions among FDA,
Washington, DC area). A notice in the notify interested persons regarding their pharmaceutical sponsors, the academic
Federal Register about last minute request to speak by July 17, 2018. community, and the public. This draft
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![Federal Register / Vol. 83, No. 120 / Thursday, June 21, 2018 / Notices 28853
Dated: June 15, 2018. as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed
Leslie Kux, that if you include your name, contact except in accordance with 21 CFR 10.20
Associate Commissioner for Policy. information, or other information that and other applicable disclosure law. For
[FR Doc. 2018–13297 Filed 6–20–18; 8:45 am] identifies you in the body of your more information about FDA’s posting
BILLING CODE 4164–01–P
comments, that information will be of comments to public dockets, see 80
posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access
• If you want to submit a comment the information at: https://www.gpo.gov/
DEPARTMENT OF HEALTH AND with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015-
HUMAN SERVICES do not wish to be made available to the 23389.pdf.
public, submit the comment as a Docket: For access to the docket to
Food and Drug Administration written/paper submission and in the read background documents or the
manner detailed (see ‘‘Written/Paper electronic and written/paper comments
[Docket No. FDA–2011–D–0108]
Submissions’’ and ‘‘Instructions’’). received, go to https://
Prescription Drug User Fee Act Written/Paper Submissions www.regulations.gov and insert the
Waivers, Reductions, and Refunds for docket number, found in brackets in the
Submit written/paper submissions as heading of this document, into the
Drug and Biological Products; Draft follows:
Guidance for Industry; Availability ‘‘Search’’ box and follow the prompts
• Mail/Hand delivery/Courier (for
and/or go to the Dockets Management
AGENCY: Food and Drug Administration, written/paper submissions): Dockets
Staff, 5630 Fishers Lane, Rm. 1061,
HHS. Management Staff (HFA–305), Food and
Rockville, MD 20852.
Drug Administration, 5630 Fishers
ACTION: Notice of availability. Submit written requests for single
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments copies of the draft guidance to the
SUMMARY: The Food and Drug Division of Drug Information, Center for
Administration (FDA or Agency) is submitted to the Dockets Management
Staff, FDA will post your comment, as Drug Evaluation and Research, Food
announcing the availability of a draft and Drug Administration, 10001 New
guidance for industry entitled well as any attachments, except for
information submitted, marked and Hampshire Ave., Hillandale Building,
‘‘Prescription Drug Act User Fee 4th Floor, Silver Spring, MD 20993–
Waivers, Reductions, and Refunds for identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’ 0002 or to the Office of Communication,
Drug and Biological Products.’’ This Outreach and Development, Center for
revised draft guidance provides Instructions: All submissions received
must include the Docket No. FDA– Biologics Evaluation and Research,
recommendations to applicants Food and Drug Administration, 10903
planning to request a waiver or 2011–D–0108 for ‘‘Prescription Drug Act
User Fee Waivers, Reductions, and New Hampshire Ave., Bldg. 71, Rm.
reduction in user fees. This draft 3128, Silver Spring, MD 20993–0002.
guidance is a revision of the guidance Refunds for Drug and Biological
Products.’’ Received comments will be Send one self-addressed adhesive label
for industry entitled ‘‘User Fee Waivers, to assist the office in processing your
Reductions, and Refunds for Drug and placed in the docket and, except for
those submitted as ‘‘Confidential requests. See the SUPPLEMENTARY
Biological Products,’’ issued in INFORMATION section for electronic
September 2011. Submissions,’’ publicly viewable at
https://www.regulations.gov or at the access to the draft guidance document.
DATES: Although you can comment on FOR FURTHER INFORMATION CONTACT:
Dockets Management Staff between 9
any draft guidance at any time (see 21 a.m. and 4 p.m., Monday through Sungjoon ‘‘Alvin’’ Chi, Center for Drug
CFR 10.115(g)(5)), to ensure that the Friday. Evaluation and Research, Food and
Agency considers your comment on this • Confidential Submissions—To Drug Administration, 10001 New
draft guidance before it begins work on submit a comment with confidential Hampshire Ave., Rm. 2185, Silver
the final version of the guidance, submit information that you do not wish to be Spring, MD 20993, 301–796–7900,
either electronic or written comments made publicly available, submit your CDERCollections@fda.hhs.gov; or
on the draft guidance by August 20, comments only as a written/paper Stephen Ripley, Center for Biologics
2018. submission. You should submit two Evaluation and Research, Food and
ADDRESSES: You may submit comments copies total. One copy will include the Drug Administration, 10903 New
as follows: information you claim to be confidential Hampshire Ave., Bldg. 71, Rm. 7301,
with a heading or cover note that states Silver Spring, MD 20993–0002, 240–
Electronic Submissions ‘‘THIS DOCUMENT CONTAINS 402–7911.
Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The SUPPLEMENTARY INFORMATION:
following way: Agency will review this copy, including
• Federal eRulemaking Portal: the claimed confidential information, in I. Background
https://www.regulations.gov. Follow the its consideration of comments. The FDA is announcing the availability of
instructions for submitting comments. second copy, which will have the a draft guidance for industry entitled
Comments submitted electronically, claimed confidential information ‘‘Prescription Drug User Fee Waivers,
including attachments, to https:// redacted/blacked out, will be available Reductions, and Refunds for Drug and
www.regulations.gov will be posted to for public viewing and posted on Biological Products.’’ This draft
the docket unchanged. Because your https://www.regulations.gov. Submit guidance provides recommendations to
comment will be made public, you are both copies to the Dockets Management applicants regarding requests for
amozie on DSK3GDR082PROD with NOTICES1
solely responsible for ensuring that your Staff. If you do not wish your name and waivers, reductions, or refunds of user
comment does not include any contact information to be made publicly fees assessed under sections 735 and
confidential information that you or a available, you can provide this 736 (21 U.S.C. 379g and 379h) of the
third party may not wish to be posted, information on the cover sheet and not Federal Food, Drug, and Cosmetic
such as medical information, your or in the body of your comments and you (FD&C) Act. This revised draft guidance
anyone else’s Social Security number, or must identify this information as describes the types of waivers,
confidential business information, such ‘‘confidential.’’ Any information marked reductions, and refunds permitted
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Document Created: 2018-06-21 01:23:07
Document Modified: 2018-06-21 01:23:07
| 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 | Submit either electronic or written comments on the draft guidance by August 20, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Juliette Tour[eacute], Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4120, Silver Spring, MD 20993-0002, 301- 796-2260. | |
| FR Citation | 83 FR 28851 |
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