83 FR 15155 - International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Cannabis Plant and Resin; Extracts and Tinctures of Cannabis; Delta-9-Tetrahydrocannabinol; Stereoisomers of Tetrahydrocannabinol; Cannabidiol; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 68 (April 9, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 68 (April 9, 2018)
| Page Range | 15155-15157 | |
| FR Document | 2018-07225 |
[Federal Register Volume 83, Number 68 (Monday, April 9, 2018)] [Notices] [Pages 15155-15157] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-07225] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-1072] International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Cannabis Plant and Resin; Extracts and Tinctures of Cannabis; Delta-9- Tetrahydrocannabinol; Stereoisomers of Tetrahydrocannabinol; Cannabidiol; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is requesting interested persons to submit comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of five drug substances. These comments will be considered in preparing a response from the United States to the World Health Organization (WHO) regarding the abuse liability and diversion of these drugs. WHO will use this information to consider whether to recommend that certain international restrictions be placed on these drugs. This notice requesting comments is required by the Controlled Substances Act (the CSA). DATES: Submit either electronic or written comments by April 23, 2018. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 23, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 23, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2018-N-1072 for ``International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Cannabis Plant and Resin; Extracts and Tinctures of Cannabis; Delta-9- Tetrahydrocannabinol (THC); Stereoisomers of THC; Cannabidiol; Request for Comments.'' 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 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 [[Page 15156]] 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: James R. Hunter, Center for Drug Evaluation and Research, Controlled Substance Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5150, Silver Spring, MD 20993-0002, 301-796-3156, email: [email protected]. SUPPLEMENTARY INFORMATION: I. Background The United States is a party to the 1971 Convention on Psychotropic Substances (Psychotropic Convention). Article 2 of the Psychotropic Convention provides that if a party to the convention or WHO has information about a substance, which in its opinion may require international control or change in such control, it shall so notify the Secretary-General of the United Nations (the U.N. Secretary-General) and provide the U.N. Secretary-General with information in support of its opinion. Paragraph (d)(2)(A) of the CSA (21 U.S.C. 811) (Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970) provides that when WHO notifies the United States under Article 2 of the Psychotropic Convention that it has information that may justify adding a drug or other substances to one of the schedules of the Psychotropic Convention, transferring a drug or substance from one schedule to another, or deleting it from the schedules, the Secretary of State must transmit the notice to the Secretary of Health and Human Services (Secretary of HHS). The Secretary of HHS must then publish the notice in the Federal Register and provide opportunity for interested persons to submit comments that will be considered by HHS in its preparation of the scientific and medical evaluations of the drug or substance. II. WHO Notification The Secretary of HHS received the following notice from WHO (non- relevant text removed): Ref.: C.L.2.2018 The World Health Organization (WHO) presents its compliments to Member States and Associate Members and has the pleasure of informing that the 40th Expert Committee on Drug Dependence (ECDD) will meet in Geneva from 4 to 8 June 2018. The 40th ECDD will convene in a special session to review cannabis and cannabis-related substances on their potential to cause dependence, abuse and harm to health, and potential therapeutic applications. WHO will make recommendations to the UN Secretary-General on the need for and level of international control of these substances. Recommendations made from the 39th meeting can be found on the ECDD website (https://www.who.int/mason/entity/medicines/news/2017/letter-DG-39thECDDrecommendations.pdf?ua=1). At its 126th session in January 2010, the Executive Board approved the publication ``Guidance on the WHO review of psychoactive substances for international control'' (EB126/2010/ REC1, Annex 6) which requires the Secretariat to request relevant information from Ministers of Health in Member States to prepare a report for submission to the ECDD. For this purpose, a questionnaire was designed to gather information on the legitimate use, harmful use, status of national control and potential impact of international control for each substance under evaluation. Member States are invited to collaborate, as in the past, in this process by providing pertinent information as requested in the questionnaire and concerning substances under review. It would be appreciated if a person from the Ministry of Health could be designated as the focal point responsible for coordinating answers to the questionnaires. A list of focal points designated by Member States for the 39th ECDD in November 2017 is attached. It is requested that if a focal point's contact details including email address are to be added or amended, that Member States inform the Secretariat by 26 February 2018. Any additions or amendments to focal point designations should be emailed to [email protected]. If no additions or amendments to focal point details are made by this date, the focal point from 2017 will be approached by the Secretariat for questionnaire completion. Where there is a competent National Authority under the International Drug Control Treaties, it is kindly requested that the questionnaires be completed in collaboration with such body. Once the Secretariat has received the contact details, focal points will be given further instructions and direct access to an online questionnaire. The questionnaires will be analysed by the Secretariat and prepared as a report that will be published on the ECDD website (https://www.who.int/medicines/access/controlled-substances/ecdd/en/) prior to the 40th ECDD meeting. The provisional agenda for the meeting will also be made available in advance on the ECDD website. Member States are also encouraged to provide any additional relevant information (unpublished or published) that is available on these substances to: [email protected]. This information will be an invaluable contribution to the ECDD and all submissions will be treated as confidential. The WHO takes this opportunity to renew to Member States and Associate Members the assurance of its highest consideration. GENEVA, 30 January 2018 FDA has verified the website addresses contained in the WHO notice, as of the date this document publishes in the Federal Register, but websites are subject to change over time. Access to view the WHO questionnaire can be found at https://www.who.int/medicines/access/controlled-substances/ecdd/en/. III. Substances Under WHO Review WHO will convene in a special session to review the following substances: Cannabis plant and resin; extracts and tinctures of cannabis; delta-9-tetrahydrocannabinol (THC; stereoisomers of THC; and cannabidiol (CBD). The Committee from the 37th ECDD requested that Secretariat begin collecting data towards a pre-review of cannabis, cannabis resin, extracts, and tinctures of cannabis at a future meeting. Subsequent to this request, WHO commissioned two updates on the scientific literature for cannabis and cannabis resin, which were prepared and presented to the 38th ECDD. That Committee noted that the current Schedule I under the 1961 Convention groups together cannabis and cannabis resin, extracts, and tinctures of cannabis, that cannabis plant and cannabis resin are also in Schedule IV of the 1961 Convention, that there are natural and synthetic cannabinoids in Schedule I and Schedule II of the 1971 Convention, and that cannabis had never been subject to pre-review or critical review by the ECDD. The Committee also noted an increase in the use of cannabis and its components for medical purposes and the emergence of new cannabis-related pharmaceutical preparations for therapeutic use. From this review, the 38th ECDD Committee recommended that preparations be made to conduct pre-reviews at a future meeting dedicated to the following substances: Cannabis plant and cannabis resin, extracts and tinctures of cannabis, THC, CBD, and stereoisomers of THC. An excerpt from the report of the 38th ECDD stated that the purpose of the pre-review was to determine whether current information justifies an Expert Committee critical review. They noted that the categories of information for evaluating substances in pre-reviews are identical to those used in critical reviews and that the pre-review is a preliminary analysis, and findings should not determine whether the [[Page 15157]] control status of a substance should be changed. Cannabis, also known as marijuana, refers to the dried leaves, flowers, stems, and seeds from the Cannabis sativa or Cannabis indica plant. It is a complex plant substance containing multiple cannabinoids and other compounds, including the psychoactive chemical THC and other structurally similar compounds. Cannabinoids are defined as having activity at cannabinoid 1 and 2 (CB1 and CB2 respectively) receptors. Agonists of CB1 receptors are widely abused and are known to modulate motor coordination, memory processing, pain, and inflammation, and have anxiolytic effects. Marijuana is the most commonly used illicit drug in the United States. The principal cannabinoids in the cannabis plant include THC, CBD, and cannabinol. FDA has not approved any product containing or derived from botanical marijuana for any indication. These substances are controlled in Schedule I under the CSA. Synthetic THC (dronabinol) is the active ingredient in two approved drug products in the United States, MARINOL capsules (and generics) and SYNDROS oral solution. MARINOL is controlled in Schedule III, while SYNDROS is controlled in Schedule II under the CSA. Both MARINOL and SYNDROS are approved to treat anorexia associated with weight loss in patients with acquired immunodeficiency syndrome (AIDS), and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional treatment. CBD is another cannabinoid identified in cannabis. CBD has been tested in experimental animal and laboratory models of several neurological disorders, including those of seizure and epilepsy. In the United States, CBD-containing products are in human clinical testing in several therapeutic areas, but no such products have marketing approval by FDA for any medical purposes in the United States. CBD is controlled as a Schedule I substance under the CSA. CBD is not specifically listed in the schedules of the 1961, 1971, or 1988 International Drug Control conventions. At the 39th (2017) meeting of the ECDD, the committee pre-reviewed CBD and recommended that extracts or preparations containing almost exclusively CBD be subject to critical review at the 40th ECDD meeting. IV. Opportunity To Submit Domestic Information As required by paragraph (d)(2)(A) of the CSA, FDA, on behalf of HHS, invites interested persons to submit comments regarding the five drug substances. Any comments received will be considered by HHS when it prepares a scientific and medical evaluation of these drug substances, responsive to the WHO Questionnaire request for these drug substances. HHS will forward such evaluation of these drug substances to WHO, for WHO's consideration in deciding whether to recommend international control/decontrol of any of these drug substances. Such control could limit, among other things, the manufacture and distribution (import/export) of these drug substances and could impose certain recordkeeping requirements on them. Although FDA is, through this notice, requesting comments from interested persons, which will be considered by HHS when it prepares an evaluation of these drug substances, HHS will not now make any recommendations to WHO regarding whether any of these drugs should be subjected to international controls. Instead, HHS will defer such consideration until WHO has made official recommendations to the Commission on Narcotic Drugs, which are expected to be made in mid- 2018. Any HHS position regarding international control of these drug substances will be preceded by another Federal Register notice soliciting public comments, as required by paragraph (d)(2)(B) of the CSA. Dated: April 4, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-07225 Filed 4-6-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 68 / Monday, April 9, 2018 / Notices 15155
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 2
Number of dis-
Number of re- Total annual Average burden per dis-
Type of respondent closures per Total hours
spondents disclosures closure
respondent
Establishments listing fewer than 10 SUDs ......... 58 2 116 0.1 (6 minutes) ............. 12
Establishments listing 10 or more SUDs .............. 9 34 306 0.1 (6 minutes) ............. 31
Total ............................................................... ........................ ........................ ........................ ....................................... 43
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 Numbers have been rounded.
The burden for this information 2018. The https://www.regulations.gov identified, as confidential, if submitted
collection has not changed since the last electronic filing system will accept as detailed in ‘‘Instructions.’’
OMB approval. comments until midnight Eastern Time Instructions: All submissions received
Dated: April 3, 2018. at the end of April 23, 2018. Comments must include the Docket No. FDA–
Leslie Kux,
received by mail/hand delivery/courier 2018–N–1072 for ‘‘International Drug
(for written/paper submissions) will be Scheduling; Convention on
Associate Commissioner for Policy.
considered timely if they are Psychotropic Substances; Single
[FR Doc. 2018–07152 Filed 4–6–18; 8:45 am] postmarked or the delivery service Convention on Narcotic Drugs; Cannabis
BILLING CODE 4164–01–P acceptance receipt is on or before that Plant and Resin; Extracts and Tinctures
date. of Cannabis; Delta-9-
DEPARTMENT OF HEALTH AND Electronic Submissions Tetrahydrocannabinol (THC);
HUMAN SERVICES Stereoisomers of THC; Cannabidiol;
Submit electronic comments in the Request for Comments.’’ Received
following way: comments, those filed in a timely
Food and Drug Administration • Federal eRulemaking Portal: manner (see ADDRESSES), will be placed
[Docket No. FDA–2018–N–1072] https://www.regulations.gov. Follow the
in the docket and, except for those
instructions for submitting comments.
submitted as ‘‘Confidential
International Drug Scheduling; Comments submitted electronically,
Submissions,’’ publicly viewable at
Convention on Psychotropic including attachments, to https://
https://www.regulations.gov or at the
Substances; Single Convention on www.regulations.gov will be posted to
Dockets Management Staff between 9
Narcotic Drugs; Cannabis Plant and the docket unchanged. Because your
a.m. and 4 p.m., Monday through
Resin; Extracts and Tinctures of comment will be made public, you are
Friday.
Cannabis; Delta-9- solely responsible for ensuring that your
Tetrahydrocannabinol; Stereoisomers comment does not include any • Confidential Submissions—To
of Tetrahydrocannabinol; Cannabidiol; confidential information that you or a submit a comment with confidential
Request for Comments third party may not wish to be posted, information that you do not wish to be
such as medical information, your or made publicly available, submit your
AGENCY: Food and Drug Administration, comments only as a written/paper
anyone else’s Social Security number, or
HHS. submission. You should submit two
confidential business information, such
ACTION: Notice; request for comments. as a manufacturing process. Please note copies total. One copy will include the
that if you include your name, contact information you claim to be confidential
SUMMARY: The Food and Drug with a heading or cover note that states
Administration (FDA) is requesting information, or other information that
identifies you in the body of your ‘‘THIS DOCUMENT CONTAINS
interested persons to submit comments CONFIDENTIAL INFORMATION.’’ The
concerning abuse potential, actual comments, that information will be
posted on https://www.regulations.gov. Agency will review this copy, including
abuse, medical usefulness, trafficking, the claimed confidential information, in
and impact of scheduling changes on • If you want to submit a comment
with confidential information that you its consideration of comments. The
availability for medical use of five drug second copy, which will have the
substances. These comments will be do not wish to be made available to the
public, submit the comment as a claimed confidential information
considered in preparing a response from redacted/blacked out, will be available
the United States to the World Health written/paper submission and in the
manner detailed (see ‘‘Written/Paper for public viewing and posted on
Organization (WHO) regarding the abuse https://www.regulations.gov. Submit
liability and diversion of these drugs. Submissions’’ and ‘‘Instructions’’).
both copies to the Dockets Management
WHO will use this information to Written/Paper Submissions Staff. If you do not wish your name and
consider whether to recommend that contact information to be made publicly
Submit written/paper submissions as
certain international restrictions be available, you can provide this
follows:
placed on these drugs. This notice • Mail/Hand delivery/Courier (for information on the cover sheet and not
requesting comments is required by the written/paper submissions): Dockets in the body of your comments and you
Controlled Substances Act (the CSA). must identify this information as
sradovich on DSK3GMQ082PROD with NOTICES
Management Staff (HFA–305), Food and
DATES: Submit either electronic or Drug Administration, 5630 Fishers ‘‘confidential.’’ Any information marked
written comments by April 23, 2018. Lane, Rm. 1061, Rockville, MD 20852. as ‘‘confidential’’ will not be disclosed
ADDRESSES: You may submit comments • For written/paper comments except in accordance with 21 CFR 10.20
as follows. Please note that late, submitted to the Dockets Management and other applicable disclosure law. For
untimely filed comments will not be Staff, FDA will post your comment, as more information about FDA’s posting
considered. Electronic comments must well as any attachments, except for of comments to public dockets, see 80
be submitted on or before April 23, information submitted, marked and FR 56469, September 18, 2015, or access
VerDate Sep<11>2014 18:06 Apr 06, 2018 Jkt 244001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\FR\FM\09APN1.SGM 09APN1](https://thefederalregister.org/doc/83_FR_15223/page/1.svg)
![Federal Register / Vol. 83, No. 68 / Monday, April 9, 2018 / Notices 15157
control status of a substance should be IV. Opportunity To Submit Domestic During Development of Systemic
changed. Information Drugs.’’ This draft guidance addresses
Cannabis, also known as marijuana, As required by paragraph (d)(2)(A) of FDA’s current thinking about the
refers to the dried leaves, flowers, stems, the CSA, FDA, on behalf of HHS, invites relevant age groups to study and how
and seeds from the Cannabis sativa or interested persons to submit comments early in the drug development pediatric
regarding the five drug substances. Any patients should be incorporated during
Cannabis indica plant. It is a complex
comments received will be considered development of systemic drugs for
plant substance containing multiple
by HHS when it prepares a scientific atopic dermatitis (AD).
cannabinoids and other compounds,
and medical evaluation of these drug DATES: Submit either electronic or
including the psychoactive chemical
THC and other structurally similar substances, responsive to the WHO written comments on the draft guidance
Questionnaire request for these drug by June 8, 2018 to ensure that the
compounds. Cannabinoids are defined
substances. HHS will forward such Agency considers your comment on this
as having activity at cannabinoid 1 and
evaluation of these drug substances to draft guidance before it begins work on
2 (CB1 and CB2 respectively) receptors. the final version of the guidance.
WHO, for WHO’s consideration in
Agonists of CB1 receptors are widely
deciding whether to recommend ADDRESSES: You may submit comments
abused and are known to modulate
international control/decontrol of any of on any guidance at any time as follows:
motor coordination, memory processing,
these drug substances. Such control
pain, and inflammation, and have could limit, among other things, the Electronic Submissions
anxiolytic effects. Marijuana is the most manufacture and distribution (import/ Submit electronic comments in the
commonly used illicit drug in the export) of these drug substances and following way:
United States. could impose certain recordkeeping • Federal eRulemaking Portal:
The principal cannabinoids in the requirements on them. https://www.regulations.gov. Follow the
cannabis plant include THC, CBD, and Although FDA is, through this notice, instructions for submitting comments.
cannabinol. FDA has not approved any requesting comments from interested Comments submitted electronically,
product containing or derived from persons, which will be considered by including attachments, to https://
botanical marijuana for any indication. HHS when it prepares an evaluation of www.regulations.gov will be posted to
These substances are controlled in these drug substances, HHS will not the docket unchanged. Because your
Schedule I under the CSA. Synthetic now make any recommendations to comment will be made public, you are
THC (dronabinol) is the active WHO regarding whether any of these solely responsible for ensuring that your
ingredient in two approved drug drugs should be subjected to comment does not include any
products in the United States, international controls. Instead, HHS will confidential information that you or a
MARINOL capsules (and generics) and defer such consideration until WHO has third party may not wish to be posted,
SYNDROS oral solution. MARINOL is made official recommendations to the such as medical information, your or
controlled in Schedule III, while Commission on Narcotic Drugs, which anyone else’s Social Security number, or
SYNDROS is controlled in Schedule II are expected to be made in mid-2018. confidential business information, such
Any HHS position regarding as a manufacturing process. Please note
under the CSA. Both MARINOL and
international control of these drug that if you include your name, contact
SYNDROS are approved to treat
substances will be preceded by another information, or other information that
anorexia associated with weight loss in
Federal Register notice soliciting public identifies you in the body of your
patients with acquired
comments, as required by paragraph comments, that information will be
immunodeficiency syndrome (AIDS), (d)(2)(B) of the CSA. posted on https://www.regulations.gov.
and nausea and vomiting associated • If you want to submit a comment
with cancer chemotherapy in patients Dated: April 4, 2018.
Leslie Kux, with confidential information that you
who have failed to respond adequately do not wish to be made available to the
to conventional treatment. Associate Commissioner for Policy.
public, submit the comment as a
[FR Doc. 2018–07225 Filed 4–6–18; 8:45 am]
CBD is another cannabinoid identified written/paper submission and in the
BILLING CODE 4164–01–P
in cannabis. CBD has been tested in manner detailed (see ‘‘Written/Paper
experimental animal and laboratory Submissions’’ and ‘‘Instructions’’).
models of several neurological DEPARTMENT OF HEALTH AND Written/Paper Submissions
disorders, including those of seizure HUMAN SERVICES
and epilepsy. In the United States, CBD- Submit written/paper submissions as
containing products are in human Food and Drug Administration follows:
clinical testing in several therapeutic • Mail/Hand delivery/Courier (for
[Docket No. FDA–2018–D–1175] written/paper submissions): Dockets
areas, but no such products have
marketing approval by FDA for any Management Staff (HFA–305), Food and
Atopic Dermatitis: Timing of Pediatric Drug Administration, 5630 Fishers
medical purposes in the United States. Studies During Development of
CBD is controlled as a Schedule I Lane, Rm. 1061, Rockville, MD 20852.
Systemic Drugs; Draft Guidance for • For written/paper comments
substance under the CSA. CBD is not Industry; Availability submitted to the Dockets Management
specifically listed in the schedules of
AGENCY: Food and Drug Administration, Staff, FDA will post your comment, as
the 1961, 1971, or 1988 International
well as any attachments, except for
sradovich on DSK3GMQ082PROD with NOTICES
Drug Control conventions. HHS.
ACTION: Notice of availability. information submitted, marked and
At the 39th (2017) meeting of the identified, as confidential, if submitted
ECDD, the committee pre-reviewed CBD SUMMARY: The Food and Drug as detailed in ‘‘Instructions.’’
and recommended that extracts or Administration (FDA or Agency) is Instructions: All submissions received
preparations containing almost announcing the availability of a draft must include the Docket No. FDA–
exclusively CBD be subject to critical guidance for industry entitled ‘‘Atopic 2018–D–1175 for ‘‘Atopic Dermatitis:
review at the 40th ECDD meeting. Dermatitis: Timing of Pediatric Studies Timing of Pediatric Studies During
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Document Created: 2018-04-07 02:39:31
Document Modified: 2018-04-07 02:39:31
| 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; request for comments. | |
| Dates | Submit either electronic or written comments by April 23, 2018. | |
| Contact | James R. Hunter, Center for Drug Evaluation and Research, Controlled Substance Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5150, Silver Spring, MD 20993-0002, 301-796-3156, email: [email protected] | |
| FR Citation | 83 FR 15155 |
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