83 FR 15157 - Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs; Draft Guidance for Industry; Availability
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 | 15157-15158 | |
| FR Document | 2018-07150 |
[Federal Register Volume 83, Number 68 (Monday, April 9, 2018)] [Notices] [Pages 15157-15158] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-07150] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-1175] Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs.'' This draft guidance addresses FDA's current thinking about the relevant age groups to study and how early in the drug development pediatric patients should be incorporated during development of systemic drugs for atopic dermatitis (AD). DATES: Submit either electronic or written comments on the draft guidance by June 8, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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-1175 for ``Atopic Dermatitis: Timing of Pediatric Studies During [[Page 15158]] Development of Systemic Drugs; Draft 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 ``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, or Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, 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: Dawn Williams, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5168, Silver Spring, MD 20993-0002, 301- 796-5376; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs.'' This draft guidance addresses FDA's current thinking about the relevant age groups to study and how early in the drug development pediatric patients should be incorporated during development of systemic drugs for AD. 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 the timing of pediatric studies during development of systemic drugs for atopic dermatitis. 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. Electronic Access Persons with access to the internet may obtain the draft guidance at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov. Dated: April 2, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-07150 Filed 4-6-18; 8:45 am] BILLING CODE 4164-01-P
![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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![15158 Federal Register / Vol. 83, No. 68 / Monday, April 9, 2018 / Notices
Development of Systemic Drugs; Draft Biologics Evaluation and Research, DEPARTMENT OF HEALTH AND
Guidance for Industry; Availability.’’ Food and Drug Administration, 10903 HUMAN SERVICES
Received comments will be placed in New Hampshire Ave., Bldg. 71, Rm.
the docket and, except for those 3128, Silver Spring, MD 20993–0002. Food and Drug Administration
submitted as ‘‘Confidential Send one self-addressed adhesive label [Docket No. FDA–2014–N–1414]
Submissions,’’ publicly viewable at to assist that office in processing your
https://www.regulations.gov or at the requests. See the SUPPLEMENTARY Agency Information Collection
Dockets Management Staff between 9 INFORMATION section for electronic Activities; Submission for Office of
a.m. and 4 p.m., Monday through access to the draft guidance document. Management and Budget Review;
Friday. Comment Request; Class II Special
• Confidential Submissions—To FOR FURTHER INFORMATION CONTACT:
Controls Guidance Document:
submit a comment with confidential Dawn Williams, Center for Drug
Labeling Natural Rubber Latex
information that you do not wish to be Evaluation and Research, Food and
Condoms
made publicly available, submit your Drug Administration, 10903 New
comments only as a written/paper Hampshire Ave., Bldg. 22, Rm. 5168, AGENCY: Food and Drug Administration,
submission. You should submit two Silver Spring, MD 20993–0002, 301– HHS.
copies total. One copy will include the 796–5376; or Stephen Ripley, Center for ACTION: Notice.
information you claim to be confidential Biologics Evaluation and Research,
with a heading or cover note that states Food and Drug Administration, 10903 SUMMARY: The Food and Drug
‘‘THIS DOCUMENT CONTAINS New Hampshire Ave., Bldg. 71, Rm. Administration (FDA) is announcing
CONFIDENTIAL INFORMATION.’’ The 7301, Silver Spring, MD 20993–0002, that a proposed collection of
Agency will review this copy, including 240–402–7911. information has been submitted to the
the claimed confidential information, in Office of Management and Budget
SUPPLEMENTARY INFORMATION: (OMB) for review and clearance under
its consideration of comments. The
second copy, which will have the I. Background the Paperwork Reduction Act of 1995
claimed confidential information (PRA).
redacted/blacked out, will be available FDA is announcing the availability of DATES: Fax written comments on the
for public viewing and posted on a draft guidance for industry entitled collection of information by May 9,
https://www.regulations.gov. Submit ‘‘Atopic Dermatitis: Timing of Pediatric 2018.
both copies to the Dockets Management Studies During Development of
ADDRESSES: To ensure that comments on
Staff. If you do not wish your name and Systemic Drugs.’’ This draft guidance
contact information to be made publicly addresses FDA’s current thinking about the information collection are received,
available, you can provide this the relevant age groups to study and OMB recommends that written
information on the cover sheet and not how early in the drug development comments be faxed to the Office of
in the body of your comments and you pediatric patients should be Information and Regulatory Affairs,
must identify this information as incorporated during development of OMB, Attn: FDA Desk Officer, Fax: 202–
‘‘confidential.’’ Any information marked systemic drugs for AD. 395–7285, or emailed to oira_
as ‘‘confidential’’ will not be disclosed submission@omb.eop.gov. All
This draft guidance is being issued comments should be identified with the
except in accordance with 21 CFR 10.20 consistent with FDA’s good guidance
and other applicable disclosure law. For OMB control number 0910–0633. Also
practices regulation (21 CFR 10.115). include the FDA docket number found
more information about FDA’s posting The draft guidance, when finalized, will
of comments to public dockets, see 80 in brackets in the heading of this
represent the current thinking of FDA document.
FR 56469, September 18, 2015, or access on the timing of pediatric studies during
the information at: https://www.gpo.gov/ development of systemic drugs for FOR FURTHER INFORMATION CONTACT:
fdsys/pkg/FR-2015-09-18/pdf/2015- atopic dermatitis. It does not establish Amber Sanford, Office of Operations,
23389.pdf. any rights for any person and is not Food and Drug Administration, Three
Docket: For access to the docket to White Flint North, 10A–12M, 11601
binding on FDA or the public. You can
read background documents or the Landsdown St., North Bethesda, MD
use an alternative approach if it satisfies
electronic and written/paper comments 20852, 301–796–8867, PRAStaff@
the requirements of the applicable
received, go to https:// fda.hhs.gov.
statutes and regulations. This guidance
www.regulations.gov and insert the
is not subject to Executive Order 12866. SUPPLEMENTARY INFORMATION: In
docket number, found in brackets in the
compliance with 44 U.S.C. 3507, FDA
heading of this document, into the II. Electronic Access has submitted the following proposed
‘‘Search’’ box and follow the prompts
Persons with access to the internet collection of information to OMB for
and/or go to the Dockets Management
may obtain the draft guidance at https:// review and clearance.
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. www.fda.gov/Drugs/Guidance Class II Special Controls Guidance
You may submit comments on any ComplianceRegulatoryInformation/ Document: Labeling for Natural Rubber
guidance at any time (see 21 CFR Guidances/default.htm, https:// Latex Condoms—21 CFR 884.5300
10.115(g)(5)). www.fda.gov/BiologicsBloodVaccines/
Submit written requests for single GuidanceComplianceRegulatory OMB Control Number 0910–0633—
copies of the draft guidance to the Information/default.htm, or https:// Extension
sradovich on DSK3GMQ082PROD with NOTICES
Division of Drug Information, Center for www.regulations.gov. Under the Medical Device
Drug Evaluation and Research, Food Dated: April 2, 2018. Amendments of 1976 (Pub. L. 94–295),
and Drug Administration, 10001 New class II devices were defined as those
Leslie Kux,
Hampshire Ave., Hillandale Building, devices for which there was insufficient
4th Floor, Silver Spring, MD 20993– Associate Commissioner for Policy. information to show that general
0002, or Office of Communication, [FR Doc. 2018–07150 Filed 4–6–18; 8:45 am] controls themselves would provide a
Outreach, and Development, Center for BILLING CODE 4164–01–P reasonable assurance of safety and
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Document Created: 2018-04-07 02:38:58
Document Modified: 2018-04-07 02:38:58
| 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 June 8, 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 | Dawn Williams, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5168, Silver Spring, MD 20993-0002, 301- 796-5376; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. | |
| FR Citation | 83 FR 15157 |
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