83_FR_50124 83 FR 49932 - Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs; Guidance for Industry; Availability

83 FR 49932 - Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 192 (October 3, 2018)

Page Range49932-49933
FR Document2018-21519

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs.'' This guidance addresses FDA's current thinking about the relevant age groups to study and how early in drug development applicants should incorporate pediatric patients for development of systemic drugs for atopic dermatitis (AD). This guidance finalizes the draft guidance of the same name issued on April 9, 2018.

Federal Register, Volume 83 Issue 192 (Wednesday, October 3, 2018) 
[Federal Register Volume 83, Number 192 (Wednesday, October 3, 2018)]
[Notices]
[Pages 49932-49933]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-21519]


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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; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance for industry entitled ``Atopic 
Dermatitis: Timing of Pediatric Studies During Development of Systemic 
Drugs.'' This guidance addresses FDA's current thinking about the 
relevant age groups to study and how early in drug development 
applicants should incorporate pediatric patients for development of 
systemic drugs for atopic dermatitis (AD). This guidance finalizes the 
draft guidance of the same name issued on April 9, 2018.

DATES: The announcement of the guidance is published in the Federal 
Register on October 3, 2018.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-D-1175 for ``Atopic Dermatitis: Timing of Pediatric Studies 
During Development of Systemic Drugs.'' 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 this guidance to the 
Division of Drug Information, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale 
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: 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 guidance for industry 
entitled ``Atopic Dermatitis: Timing of Pediatric Studies During 
Development of Systemic Drugs.'' This guidance addresses FDA's current 
thinking about the relevant age groups to study and how early in drug

[[Page 49933]]

development applicants should incorporate pediatric patients for 
development of systemic drugs for AD. This guidance has only minor 
editorial changes and finalizes the draft guidance of the same name 
issued on April 9, 2018 (83 FR 15157) to which no comments were 
received.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Atopic Dermatitis: Timing of Pediatric 
Studies During Development of Systemic Drugs.'' It does not establish 
any rights for any person and is not binding on FDA or the public. You 
can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations. This guidance is not subject to 
Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information related to the burden on the submission of 
new drug applications in 21 CFR 314.50(d)(7), including pediatric use 
information, have been approved under OMB control number 0910-0001. The 
collections of information related to the burden on the submission of 
investigational new drug applications in Sec.  312.47(b)(1)(iv) (21 CFR 
312.47(b)(1)(iv)), including plans for pediatric studies, have been 
approved under OMB control number 0910-0014. The collections of 
information related to the burden for requesting meetings with FDA 
about drug development programs in Sec. Sec.  312.47 and 312.82 have 
been approved under OMB control number 0910-0429. The collections of 
information related to the burden on the submission of information 
about expedited review programs for serious conditions and the guidance 
for industry entitled ``Expedited Programs for Serious Conditions--
Drugs and Biologics'' (available at https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm358301.pdf) have 
been approved under OMB control number 0910-0765. The collections of 
information referenced in this guidance that are related to the burden 
on the submission of biologics license applications covered under 21 
CFR part 601, including pediatric use information, have been approved 
under OMB control number 0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
https://www.regulations.gov.

    Dated: September 27, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21519 Filed 10-2-18; 8:45 am]
 BILLING CODE 4164-01-P

49932 Federal Register / Vol. 83, No. 192 / Wednesday, October 3, 2018 / Notices Naturalization Service (INS) to the including attachments, to https:// redacted/blacked out, will be available Director of ORR of the Department of www.regulations.gov will be posted to for public viewing and posted on Health and Human Services (HHS). the docket unchanged. Because your https://www.regulations.gov. Submit (B) The Flores Settlement Agreement, comment will be made public, you are both copies to the Dockets Management Case No. CV85–4544RJK (C.D. Cal. solely responsible for ensuring that your Staff. If you do not wish your name and 1996), as well as the William comment does not include any contact information to be made publicly Wilberforce Trafficking Victims confidential information that you or a available, you can provide this Protection Reauthorization Act of 2008 third party may not wish to be posted, information on the cover sheet and not (Pub. L. 110–457), which authorizes such as medical information, your or in the body of your comments and you post release services under certain anyone else’s Social Security number, or must identify this information as conditions to eligible children. All confidential business information, such ‘‘confidential.’’ Any information marked programs must comply with the Flores as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed Settlement Agreement, Case No. CV85– that if you include your name, contact except in accordance with 21 CFR 10.20 4544–RJK (C.D. Cal. 1996), pertinent information, or other information that and other applicable disclosure law. For regulations and ORR policies and identifies you in the body of your more information about FDA’s posting procedures. 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 Karen Shields, • If you want to submit a comment the information at: https://www.gpo.gov/ Grants Policy Specialist, Division of Grants with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015- Policy, Office of Administration. do not wish to be made available to the 23389.pdf. [FR Doc. 2018–21454 Filed 9–28–18; 11:15 am] public, submit the comment as a Docket: For access to the docket to BILLING CODE 4184–45–P written/paper submission and in the read background documents or the manner detailed (see ‘‘Written/Paper electronic and written/paper comments Submissions’’ and ‘‘Instructions’’). received, go to https:// DEPARTMENT OF HEALTH AND Written/Paper Submissions www.regulations.gov and insert the HUMAN SERVICES docket number, found in brackets in the Submit written/paper submissions as Food and Drug Administration heading of this document, into the follows: ‘‘Search’’ box and follow the prompts [Docket No. FDA–2018–D–1175] • Mail/Hand Delivery/Courier (for and/or go to the Dockets Management written/paper submissions): Dockets Staff, 5630 Fishers Lane, Rm. 1061, Atopic Dermatitis: Timing of Pediatric Management Staff (HFA–305), Food and Rockville, MD 20852. Studies During Development of Drug Administration, 5630 Fishers You may submit comments on any Systemic Drugs; Guidance for Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments guidance at any time (see 21 CFR Industry; Availability 10.115(g)(5)). submitted to the Dockets Management AGENCY: Food and Drug Administration, Staff, FDA will post your comment, as Submit written requests for single HHS. well as any attachments, except for copies of this guidance to the Division ACTION: Notice of availability. information submitted, marked and of Drug Information, Center for Drug identified, as confidential, if submitted Evaluation and Research, Food and SUMMARY: The Food and Drug as detailed in ‘‘Instructions.’’ Drug Administration, 10001 New Administration (FDA or Agency) is Instructions: All submissions received Hampshire Ave., Hillandale Building, announcing the availability of a final must include the Docket No. FDA– 4th Floor, Silver Spring, MD 20993– guidance for industry entitled ‘‘Atopic 2018–D–1175 for ‘‘Atopic Dermatitis: 0002. Send one self-addressed adhesive Dermatitis: Timing of Pediatric Studies Timing of Pediatric Studies During label to assist that office in processing During Development of Systemic Development of Systemic Drugs.’’ your requests. See the SUPPLEMENTARY Drugs.’’ This guidance addresses FDA’s Received comments will be placed in INFORMATION section for electronic current thinking about the relevant age the docket and, except for those access to the guidance document. groups to study and how early in drug submitted as ‘‘Confidential FOR FURTHER INFORMATION CONTACT: development applicants should Submissions,’’ publicly viewable at Dawn Williams, Center for Drug incorporate pediatric patients for https://www.regulations.gov or at the Evaluation and Research, Food and development of systemic drugs for Dockets Management Staff between 9 Drug Administration, 10903 New atopic dermatitis (AD). This guidance a.m. and 4 p.m., Monday through Hampshire Ave., Bldg. 22, Rm. 5168, finalizes the draft guidance of the same Friday. Silver Spring, MD 20993–0002, 301– name issued on April 9, 2018. • Confidential Submissions—To 796–5376; or Stephen Ripley, Center for DATES: The announcement of the submit a comment with confidential Biologics Evaluation and Research, guidance is published in the Federal information that you do not wish to be Food and Drug Administration, 10903 Register on October 3, 2018. made publicly available, submit your New Hampshire Ave., Bldg. 71, Rm. ADDRESSES: You may submit either comments only as a written/paper 7301, Silver Spring, MD 20993–0002, electronic or written comments on submission. You should submit two 240–402–7911. Agency guidances at any time as copies total. One copy will include the SUPPLEMENTARY INFORMATION: follows: information you claim to be confidential with a heading or cover note that states I. Background daltland on DSKBBV9HB2PROD with NOTICES Electronic Submissions ‘‘THIS DOCUMENT CONTAINS FDA is announcing the availability of Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The a guidance for industry entitled ‘‘Atopic following way: Agency will review this copy, including Dermatitis: Timing of Pediatric Studies • Federal eRulemaking Portal: the claimed confidential information, in During Development of Systemic https://www.regulations.gov. Follow the its consideration of comments. The Drugs.’’ This guidance addresses FDA’s instructions for submitting comments. second copy, which will have the current thinking about the relevant age Comments submitted electronically, claimed confidential information groups to study and how early in drug VerDate Sep<11>2014 18:05 Oct 02, 2018 Jkt 247001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\FR\FM\03OCN1.SGM 03OCN1

Federal Register / Vol. 83, No. 192 / Wednesday, October 3, 2018 / Notices 49933 development applicants should III. Electronic Access including attachments, to https:// incorporate pediatric patients for Persons with access to the internet www.regulations.gov will be posted to development of systemic drugs for AD. may obtain the guidance at either the docket unchanged. Because your This guidance has only minor editorial https://www.fda.gov/Drugs/Guidance comment will be made public, you are changes and finalizes the draft guidance ComplianceRegulatoryInformation/ solely responsible for ensuring that your of the same name issued on April 9, Guidances/default.htm, https:// comment does not include any 2018 (83 FR 15157) to which no www.fda.gov/BiologicsBloodVaccines/ confidential information that you or a comments were received. GuidanceComplianceRegulatory third party may not wish to be posted, This guidance is being issued such as medical information, your or Information/Guidances/default.htm, or consistent with FDA’s good guidance anyone else’s Social Security number, or https://www.regulations.gov. practices regulation (21 CFR 10.115). confidential business information, such The guidance represents the current Dated: September 27, 2018. as a manufacturing process. Please note thinking of FDA on ‘‘Atopic Dermatitis: Leslie Kux, that if you include your name, contact Timing of Pediatric Studies During Associate Commissioner for Policy. information, or other information that Development of Systemic Drugs.’’ It [FR Doc. 2018–21519 Filed 10–2–18; 8:45 am] identifies you in the body of your does not establish any rights for any BILLING CODE 4164–01–P comments, that information will be person and is not binding on FDA or the posted on https://www.regulations.gov. public. You can use an alternative • If you want to submit a comment approach if it satisfies the requirements DEPARTMENT OF HEALTH AND with confidential information that you of the applicable statutes and HUMAN SERVICES do not wish to be made available to the regulations. This guidance is not subject public, submit the comment as a to Executive Order 12866. Food and Drug Administration written/paper submission and in the [Docket No. FDA–2015–D–3438] manner detailed (see ‘‘Written/Paper II. Paperwork Reduction Act of 1995 Submissions’’ and ‘‘Instructions’’). This guidance refers to previously Selection of the Appropriate Package approved collections of information Written/Paper Submissions Type Terms and Recommendations for found in FDA regulations. These Labeling Injectable Medical Products Submit written/paper submissions as collections of information are subject to Packaged in Multiple-Dose, Single- follows: review by the Office of Management and • Mail/Hand Delivery/Courier (for Dose, and Single-Patient-Use Budget (OMB) under the Paperwork written/paper submissions): Dockets Containers for Human Use; Guidance Reduction Act of 1995 (44 U.S.C. 3501– Management Staff (HFA–305), Food and for Industry; Availability 3520). The collections of information Drug Administration, 5630 Fishers related to the burden on the submission AGENCY: Food and Drug Administration, Lane, Rm. 1061, Rockville, MD 20852. of new drug applications in 21 CFR HHS. • For written/paper comments 314.50(d)(7), including pediatric use ACTION: Notice of availability. submitted to the Dockets Management information, have been approved under Staff, FDA will post your comment, as OMB control number 0910–0001. The SUMMARY: The Food and Drug well as any attachments, except for collections of information related to the Administration (FDA or Agency) is information submitted, marked and burden on the submission of announcing the availability of a final identified, as confidential, if submitted investigational new drug applications in guidance for industry entitled as detailed in ‘‘Instructions.’’ § 312.47(b)(1)(iv) (21 CFR ‘‘Selection of the Appropriate Package Instructions: All submissions received 312.47(b)(1)(iv)), including plans for Type Terms and Recommendations for must include the Docket No. FDA– pediatric studies, have been approved Labeling Injectable Medical Products 2015–D–3438 for ‘‘Selection of the under OMB control number 0910–0014. Packaged in Multiple-Dose, Single-Dose, Appropriate Package Type Terms and The collections of information related to and Single-Patient-Use Containers for Recommendations for Labeling the burden for requesting meetings with Human Use.’’ This guidance finalizes Injectable Medical Products Packaged in FDA about drug development programs the draft guidance issued October 22, Multiple-Dose, Single-Dose, and Single- in §§ 312.47 and 312.82 have been 2015, which provides recommendations Patient-Use Containers for Human Use.’’ approved under OMB control number on the selection of appropriate package Received comments will be placed in 0910–0429. The collections of type terms and selection of appropriate the docket and, except for those information related to the burden on the discard statements for injectable submitted as ‘‘Confidential submission of information about medical products for human use, Submissions,’’ publicly viewable at expedited review programs for serious packaged in multiple-dose, single-dose, https://www.regulations.gov or at the conditions and the guidance for and single-patient-use containers. Dockets Management Staff between 9 industry entitled ‘‘Expedited Programs DATES: The announcement of the a.m. and 4 p.m., Monday through for Serious Conditions—Drugs and guidance is published in the Federal Friday. Biologics’’ (available at https:// Register on October 3, 2018. • Confidential Submissions—To www.fda.gov/ucm/groups/fdagov- ADDRESSES: You may submit either submit a comment with confidential public/@fdagov-drugs-gen/documents/ electronic or written comments on information that you do not wish to be document/ucm358301.pdf) have been Agency guidances at any time as made publicly available, submit your approved under OMB control number follows: comments only as a written/paper 0910–0765. The collections of submission. You should submit two daltland on DSKBBV9HB2PROD with NOTICES information referenced in this guidance Electronic Submissions copies total. One copy will include the that are related to the burden on the Submit electronic comments in the information you claim to be confidential submission of biologics license following way: with a heading or cover note that states applications covered under 21 CFR part • Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS 601, including pediatric use https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The information, have been approved under instructions for submitting comments. Agency will review this copy, including OMB control number 0910–0338. Comments submitted electronically, the claimed confidential information, in VerDate Sep<11>2014 19:12 Oct 02, 2018 Jkt 247001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\FR\FM\03OCN1.SGM 03OCN1


Document Created: 2018-10-03 02:30:16
Document Modified: 2018-10-03 02:30:16
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
DatesThe announcement of the guidance is published in the Federal Register on October 3, 2018.
ContactDawn 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 Citation83 FR 49932 
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