83 FR 7047 - Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment; Draft Guidance for Industry; Availability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 | 7047-7048 | |
| FR Document | 2018-03222 |
[Federal Register Volume 83, Number 33 (Friday, February 16, 2018)] [Notices] [Pages 7047-7048] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-03222] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0035] Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of amyotrophic lateral sclerosis (ALS). Specifically, it addresses FDA's current thinking regarding the clinical development program and clinical trial designs for drugs to support an indication for the treatment of ALS. This guidance addresses the clinical development of drugs intended to treat the main neuromuscular aspects of ALS (i.e., muscle weakness and its direct consequences, including shortened survival). DATES: Submit either electronic or written comments on the draft guidance by April 17, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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. [[Page 7048]] 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-2013-N-0035 for ``Amyotrophic Lateral Sclerosis: 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: Billy Dunn, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4332, Silver Spring, MD 20993-0002, 301-796-2250. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment.'' ALS is a progressive neurodegenerative disease that primarily affects motor neurons in the cerebral motor cortex, brainstem, and spinal cord, leading to loss of voluntary movement and difficulty in swallowing, speaking, and breathing. The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of ALS. Specifically, it addresses FDA's current thinking regarding the clinical development program and clinical trial designs for drugs to support an indication for the treatment of ALS. This guidance addresses the clinical development of drugs intended to treat the main neuromuscular aspects of ALS (i.e., muscle weakness and its direct consequences, including shortened survival). 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 ALS. 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 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 part 312 have been approved under OMB control number 0910-0014, the collections of information in 21 CFR part 314 have been approved under OMB control number 0910-0001, and the collections of information referred to in the guidance for industry entitled ``Establishment and Operation of Clinical Trial Data Monitoring Committees'' (available at https://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm127073.pdf) have been approved under OMB control number 0910-0581. 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. Dated: February 12, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-03222 Filed 2-15-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 33 / Friday, February 16, 2018 / Notices 7047
versions of drug products under an time, FDA has determined under announcing the availability of a draft
ANDA procedure. ANDA applicants § 314.161 that LOTENSIN HCT guidance for industry entitled
must, with certain exceptions, show that (benazepril hydrochloride; ‘‘Amyotrophic Lateral Sclerosis:
the drug for which they are seeking hydrochlorothiazide) oral tablets, 5 mg Developing Drugs for Treatment.’’ The
approval contains the same active and 6.25 mg, were not withdrawn for purpose of this guidance is to assist
ingredient in the same strength and reasons of safety or effectiveness. The sponsors in the clinical development of
dosage form as the ‘‘listed drug,’’ which petitioner has identified no data or other drugs for the treatment of amyotrophic
is a version of the drug that was information suggesting that these lateral sclerosis (ALS). Specifically, it
previously approved. ANDA applicants products were withdrawn for reasons of addresses FDA’s current thinking
do not have to repeat the extensive safety or effectiveness. We have regarding the clinical development
clinical testing otherwise necessary to carefully reviewed our files for records program and clinical trial designs for
gain approval of a new drug application concerning the withdrawal of drugs to support an indication for the
(NDA). LOTENSIN HCT (benazepril treatment of ALS. This guidance
The 1984 amendments include what hydrochloride; hydrochlorothiazide) addresses the clinical development of
is now section 505(j)(7) of the Federal oral tablets, 5 mg and 6.25 mg, from drugs intended to treat the main
Food, Drug, and Cosmetic Act (21 U.S.C. sale. We have also independently neuromuscular aspects of ALS (i.e.,
355(j)(7)), which requires FDA to evaluated relevant literature and data muscle weakness and its direct
publish a list of all approved drugs. for possible post-marketing adverse consequences, including shortened
FDA publishes this list as part of the events. We have found no information survival).
‘‘Approved Drug Products With that would indicate that this drug
Therapeutic Equivalence Evaluations,’’ DATES: Submit either electronic or
product was withdrawn from sale for written comments on the draft guidance
which is known generally as the reasons of safety or effectiveness.
‘‘Orange Book.’’ Under FDA regulations, by April 17, 2018 to ensure that the
Accordingly, the Agency will Agency considers your comment on this
drugs are removed from the list if the continue to list LOTENSIN HCT
Agency withdraws or suspends draft guidance before it begins work on
(benazepril hydrochloride; the final version of the guidance.
approval of the drug’s NDA or ANDA hydrochlorothiazide) oral tablets, 5 mg
for reasons of safety or effectiveness or ADDRESSES: You may submit comments
and 6.25 mg, in the ‘‘Discontinued Drug
if FDA determines that the listed drug on any guidance at any time as follows:
Product List’’ section of the Orange
was withdrawn from sale for reasons of Book. The ‘‘Discontinued Drug Product Electronic Submissions
safety or effectiveness (21 CFR 314.162). List’’ delineates, among other items,
A person may petition the Agency to Submit electronic comments in the
drug products that have been following way:
determine, or the Agency may discontinued from marketing for reasons
determine on its own initiative, whether • Federal eRulemaking Portal:
other than safety or effectiveness. https://www.regulations.gov. Follow the
a listed drug was withdrawn from sale
ANDAs that refer to LOTENSIN HCT instructions for submitting comments.
for reasons of safety or effectiveness.
(benazepril hydrochloride; Comments submitted electronically,
This determination may be made at any
hydrochlorothiazide) oral tablets, 5 mg including attachments, to https://
time after the drug has been withdrawn
and 6.25 mg, may be approved by the www.regulations.gov will be posted to
from sale, but must be made prior to
Agency as long as they meet all other the docket unchanged. Because your
approving an ANDA that refers to the
legal and regulatory requirements for comment will be made public, you are
listed drug (§ 314.161 (21 CFR 314.161)).
the approval of ANDAs. If FDA solely responsible for ensuring that your
FDA may not approve an ANDA that
determines that labeling for this drug comment does not include any
does not refer to a listed drug.
LOTENSIN HCT (benazepril product should be revised to meet confidential information that you or a
hydrochloride; hydrochlorothiazide) current standards, the Agency will third party may not wish to be posted,
oral tablets, 5 mg and 6.25 mg, are the advise ANDA applicants to submit such such as medical information, your or
subject of NDA 020033, held by U.S. labeling. anyone else’s Social Security number, or
Pharmaceutical Holdings I, LLC, and Dated: February 9, 2018. confidential business information, such
initially approved on May 19, 1992. Leslie Kux, as a manufacturing process. Please note
LOTENSIN HCT is indicated for the Associate Commissioner for Policy. that if you include your name, contact
relief of symptoms of depression. [FR Doc. 2018–03188 Filed 2–15–18; 8:45 am] information, or other information that
LOTENSIN HCT (benazepril BILLING CODE 4164–01–P
identifies you in the body of your
hydrochloride; hydrochlorothiazide) comments, that information will be
oral tablets, 5 mg and 6.25 mg, are posted on https://www.regulations.gov.
currently listed in the ‘‘Discontinued DEPARTMENT OF HEALTH AND • If you want to submit a comment
Drug Product List’’ section of the Orange HUMAN SERVICES with confidential information that you
Book. do not wish to be made available to the
EAS Consulting Group, LLC Food and Drug Administration public, submit the comment as a
submitted a citizen petition dated written/paper submission and in the
[Docket No. FDA–2013–N–0035]
August 9, 2017 (Docket No. FDA–2017– manner detailed (see ‘‘Written/Paper
P–4852), under 21 CFR 10.30, Amyotrophic Lateral Sclerosis: Submissions’’ and ‘‘Instructions’’).
requesting that the Agency determine Developing Drugs for Treatment; Draft
whether LOTENSIN HCT (benazepril Written/Paper Submissions
daltland on DSKBBV9HB2PROD with NOTICES
Guidance for Industry; Availability
hydrochloride; hydrochlorothiazide) Submit written/paper submissions as
oral tablets, 5 mg and 6.25 mg, were AGENCY: Food and Drug Administration, follows:
withdrawn from sale for reasons of HHS. • Mail/Hand delivery/Courier (for
safety or effectiveness. ACTION: Notice of availability. written/paper submissions): Dockets
After considering the citizen petition Management Staff (HFA–305), Food and
and reviewing Agency records and SUMMARY: The Food and Drug Drug Administration, 5630 Fishers
based on the information we have at this Administration (FDA or Agency) is Lane, Rm. 1061, Rockville, MD 20852.
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![7048 Federal Register / Vol. 83, No. 33 / Friday, February 16, 2018 / Notices
• For written/paper comments You may submit comments on any (44 U.S.C. 3501–3520). The collections
submitted to the Dockets Management guidance at any time (see 21 CFR of information in 21 CFR part 312 have
Staff, FDA will post your comment, as 10.115(g)(5)). been approved under OMB control
well as any attachments, except for Submit written requests for single number 0910–0014, the collections of
information submitted, marked and copies of the draft guidance to the information in 21 CFR part 314 have
identified, as confidential, if submitted Division of Drug Information, Center for been approved under OMB control
as detailed in ‘‘Instructions.’’ Drug Evaluation and Research, Food number 0910–0001, and the collections
Instructions: All submissions received and Drug Administration, 10001 New of information referred to in the
must include the Docket No. FDA– Hampshire Ave., Hillandale Building, guidance for industry entitled
2013–N–0035 for ‘‘Amyotrophic Lateral 4th Floor, Silver Spring, MD 20993– ‘‘Establishment and Operation of
Sclerosis: Developing Drugs for 0002. Send one self-addressed adhesive Clinical Trial Data Monitoring
Treatment; Draft Guidance for label to assist that office in processing Committees’’ (available at https://
Industry’’. Received comments will be your requests. See the SUPPLEMENTARY www.fda.gov/downloads/Regulatory
placed in the docket and, except for INFORMATION section for electronic Information/Guidances/ucm127073.pdf)
access to the draft guidance document. have been approved under OMB control
those submitted as ‘‘Confidential
FOR FURTHER INFORMATION CONTACT: number 0910–0581.
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the Billy Dunn, Center for Drug Evaluation III. Electronic Access
Dockets Management Staff between 9 and Research, Food and Drug
Administration, 10903 New Hampshire Persons with access to the internet
a.m. and 4 p.m., Monday through may obtain the draft guidance at either
Friday. Ave., Bldg. 22, Rm. 4332, Silver Spring,
MD 20993–0002, 301–796–2250. https://www.fda.gov/Drugs/Guidance
• Confidential Submissions—To ComplianceRegulatoryInformation/
SUPPLEMENTARY INFORMATION:
submit a comment with confidential Guidances/default.htm or https://
information that you do not wish to be I. Background www.regulations.gov.
made publicly available, submit your Dated: February 12, 2018.
FDA is announcing the availability of
comments only as a written/paper a draft guidance for industry entitled Leslie Kux,
submission. You should submit two ‘‘Amyotrophic Lateral Sclerosis: Associate Commissioner for Policy.
copies total. One copy will include the Developing Drugs for Treatment.’’ ALS [FR Doc. 2018–03222 Filed 2–15–18; 8:45 am]
information you claim to be confidential is a progressive neurodegenerative BILLING CODE 4164–01–P
with a heading or cover note that states disease that primarily affects motor
‘‘THIS DOCUMENT CONTAINS neurons in the cerebral motor cortex,
CONFIDENTIAL INFORMATION.’’ The brainstem, and spinal cord, leading to DEPARTMENT OF HEALTH AND
Agency will review this copy, including loss of voluntary movement and HUMAN SERVICES
the claimed confidential information, in difficulty in swallowing, speaking, and
its consideration of comments. The breathing. The purpose of this guidance Food and Drug Administration
second copy, which will have the is to assist sponsors in the clinical
claimed confidential information [Docket No. FDA–2018–N–0468]
development of drugs for the treatment
redacted/blacked out, will be available of ALS. Specifically, it addresses FDA’s
for public viewing and posted on Endocrinologic and Metabolic Drugs
current thinking regarding the clinical Advisory Committee; Notice of
https://www.regulations.gov. Submit development program and clinical trial
both copies to the Dockets Management Meeting; Establishment of a Public
designs for drugs to support an Docket; Request for Comments
Staff. If you do not wish your name and indication for the treatment of ALS.
contact information to be made publicly This guidance addresses the clinical AGENCY: Food and Drug Administration,
available, you can provide this development of drugs intended to treat HHS.
information on the cover sheet and not the main neuromuscular aspects of ALS ACTION: Notice; request for comments.
in the body of your comments and you (i.e., muscle weakness and its direct
must identify this information as consequences, including shortened SUMMARY: The Food and Drug
‘‘confidential.’’ Any information marked survival). Administration (FDA) announces a
as ‘‘confidential’’ will not be disclosed This draft guidance is being issued forthcoming public advisory committee
except in accordance with 21 CFR 10.20 consistent with FDA’s good guidance meeting of the Endocrinologic and
and other applicable disclosure law. For practices regulation (21 CFR 10.115). Metabolic Drugs Advisory Committee.
more information about FDA’s posting The draft guidance, when finalized, will The general function of the committee is
of comments to public dockets, see 80 represent the current thinking of FDA to provide advice and recommendations
FR 56469, September 18, 2015, or access on developing drugs for the treatment of to FDA on regulatory issues. The
the information at: https://www.gpo.gov/ ALS. It does not establish any rights for meeting will be open to the public. FDA
fdsys/pkg/FR-2015-09-18/pdf/2015- any person and is not binding on FDA is establishing a docket for public
23389.pdf. or the public. You can use an alternative comment on this document.
Docket: For access to the docket to approach if it satisfies the requirements DATES: The meeting will be held on May
read background documents or the of the applicable statutes and 10, 2018, from 8 a.m. to 5 p.m.
electronic and written/paper comments regulations. This guidance is not subject ADDRESSES: Tommy Douglas Conference
received, go to https:// to Executive Order 12866. Center, the Ballroom, 10000 New
daltland on DSKBBV9HB2PROD with NOTICES
www.regulations.gov and insert the Hampshire Ave., Silver Spring, MD
docket number, found in brackets in the II. Paperwork Reduction Act of 1995 20903. The conference center’s
heading of this document, into the This guidance refers to previously telephone number is 240–645–4000.
‘‘Search’’ box and follow the prompts approved collections of information that Answers to commonly asked questions
and/or go to the Dockets Management are subject to review by the Office of about FDA Advisory Committee
Staff, 5630 Fishers Lane, Rm. 1061, Management and Budget (OMB) under meetings may be accessed at: https://
Rockville, MD 20852. the Paperwork Reduction Act of 1995 www.fda.gov/AdvisoryCommittees/
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Document Created: 2018-02-16 00:55:20
Document Modified: 2018-02-16 00:55:20
| 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 April 17, 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 | Billy Dunn, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4332, Silver Spring, MD 20993-0002, 301-796-2250. | |
| FR Citation | 83 FR 7047 |
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