82 FR 49837 - Pediatric Gastroesophageal Reflux Disease: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 207 (October 27, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 207 (October 27, 2017)
| Page Range | 49837-49838 | |
| FR Document | 2017-23436 |
[Federal Register Volume 82, Number 207 (Friday, October 27, 2017)] [Notices] [Pages 49837-49838] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-23436] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-5912] Pediatric Gastroesophageal Reflux Disease: Developing Drugs for Treatment; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Pediatric Gastroesophageal Reflux Disease: Developing Drugs for Treatment.'' The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the treatment of gastroesophageal reflux disease (GERD) in the pediatric patient population, including guidance on clinical presentation by age and disease, study populations, endpoints, and pharmacometric issues affecting dosing. DATES: Submit either electronic or written comments on the draft guidance by December 26, 2017 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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. [[Page 49838]] 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-2017-D-5912 for ``Pediatric Gastroesophageal Reflux Disease: Developing Drugs for Treatment; 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 http://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: Stacy Barley, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 2642, Silver Spring, MD 20993-0002, 301- 796-2137. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``Pediatric Gastroesophageal Reflux Disease: Developing Drugs for Treatment.'' The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the treatment of GERD in the pediatric patient population, including guidance on clinical presentation by age and disease, study populations, endpoints, and pharmacometric issues affecting dosing. 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 development of drugs for the treatment of GERD in the pediatric patient population. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866. II. The Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501- 3520). The collections of information in 21 CFR parts 312 and 314 have been approved under OMB control numbers 0910-0014 and 0910-0001, respectively. The collections of information in 21 CFR 201.56 and 201.57 have been approved under OMB control number 0910-0572. 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: October 23, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-23436 Filed 10-26-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices 49837
the proposed collection of information Science-Based Decisions on Products scientific disagreement with a written
is necessary for the proper performance Regulated by the Center for Veterinary decision by CVM, they may submit a
of FDA’s functions, including whether Medicine’’ (https://www.fda.gov/ request for a review of that decision by
the information will have practical downloads/AnimalVeterinary/ following the established procedures
utility; (2) the accuracy of FDA’s GuidanceComplianceEnforcement/ discussed in the guidance.
estimate of the burden of the proposed GuidanceforIndustry/UCM052393.pdf), CVM encourages applicants to begin
collection of information, including the describes the process by which CVM
validity of the methodology and the resolution of science-based disputes
formally resolves disputes relating to
assumptions used; (3) ways to enhance with discussions with the review team/
scientific controversies. A scientific
the quality, utility, and clarity of the group, including the Team Leader or
controversy involves issues concerning
information to be collected; and (4) Division Director. The Center prefers
a specific product regulated by CVM
ways to minimize the burden of the related to matters of technical expertise that differences of opinion regarding
collection of information on and requires specialized education, science or science-based policy be
respondents, including through the use training, or experience to be understood resolved between the review team/group
of automated collection techniques, and resolved. The guidance details and the applicant. If the matter is not
when appropriate, and other forms of information on how CVM intends to resolved by this preferred method then
information technology. apply provisions of existing regulations CVM recommends that the applicant
Dispute Resolution Procedures for regarding internal review of Agency follow the procedures in GFI #79.
Science-Based Decisions on Products decisions. In addition, the guidance FDA estimates the burden of this
Regulated by CVM—21 CFR Section outlines the established procedures for collection of information as follows:
10.75 persons who are sponsors, applicants, or
manufacturers of animal drugs or other
OMB Control Number 0910–0566— products regulated by CVM that wish to
Extension submit a request for review of a
CVM’s Guidance for Industry (GIF) scientific dispute. When a sponsor,
#79, ‘‘Dispute Resolution Procedures for applicant, or manufacturer has a
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR section responses per burden per Total hours
respondents responses
respondent response
10.75, Request for review of a scientific dispute ................ 1 4 4 10 40
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
In the next 3 years, CVM anticipates DEPARTMENT OF HEALTH AND by December 26, 2017 to ensure that the
receiving one or fewer requests for HUMAN SERVICES Agency considers your comment on this
review of a scientific dispute per year, draft guidance before it begins work on
on average. We base our estimate on Food and Drug Administration the final version of the guidance.
CVM’s experience over the past 6 years [Docket No. FDA–2017–D–5912] ADDRESSES: You may submit comments
in handling formal appeals for scientific on any guidance at any time as follows:
disputes. The burden of this collection Pediatric Gastroesophageal Reflux
has changed. The number of Disease: Developing Drugs for Electronic Submissions
respondents decreased from two to one Treatment; Draft Guidance for
Submit electronic comments in the
annually, the number of responses per Industry; Availability
following way:
respondent remained at four annually, AGENCY: Food and Drug Administration, • Federal eRulemaking Portal:
the hours per response remained at 10 HHS. https://www.regulations.gov. Follow the
annually, and the total number of hours ACTION: Notice of availability. instructions for submitting comments.
decreased from 80 to 40. This decrease Comments submitted electronically,
in the total hours is the result of a SUMMARY: The Food and Drug including attachments, to https://www.
natural fluctuation in the number of Administration (FDA or Agency) is regulations.gov will be posted to the
respondents taking advantage of this announcing the availability of a draft docket unchanged. Because your
dispute resolution process. guidance for industry entitled ‘‘Pediatric comment will be made public, you are
Dated: October 24, 2017.
Gastroesophageal Reflux Disease: solely responsible for ensuring that your
Developing Drugs for Treatment.’’ The comment does not include any
Anna K. Abram, purpose of this draft guidance is to confidential information that you or a
Deputy Commissioner for Policy, Planning, assist sponsors in the clinical third party may not wish to be posted,
Legislation, and Analysis. development of drugs for the treatment
asabaliauskas on DSKBBXCHB2PROD with NOTICES
such as medical information, your or
[FR Doc. 2017–23445 Filed 10–26–17; 8:45 am] of gastroesophageal reflux disease anyone else’s Social Security number, or
BILLING CODE 4164–01–P (GERD) in the pediatric patient confidential business information, such
population, including guidance on as a manufacturing process. Please note
clinical presentation by age and disease, that if you include your name, contact
study populations, endpoints, and information, or other information that
pharmacometric issues affecting dosing. identifies you in the body of your
DATES: Submit either electronic or comments, that information will be
written comments on the draft guidance posted on https://www.regulations.gov.
VerDate Sep<11>2014 17:54 Oct 26, 2017 Jkt 244001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\27OCN1.SGM 27OCN1](https://thefederalregister.org/doc/82_FR_50044/page/1.svg)
![49838 Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices
• If you want to submit a comment FR 56469, September 18, 2015, or access II. The Paperwork Reduction Act of
with confidential information that you the information at: https://www.gpo.gov/ 1995
do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015- This guidance refers to previously
public, submit the comment as a 23389.pdf. approved collections of information that
written/paper submission and in the Docket: For access to the docket to are subject to review by the Office of
manner detailed (see ‘‘Written/Paper read background documents or the Management and Budget (OMB) under
Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments the Paperwork Reduction Act of 1995
Written/Paper Submissions received, go to https://www. (44 U.S.C. 3501–3520). The collections
regulations.gov and insert the docket of information in 21 CFR parts 312 and
Submit written/paper submissions as
number, found in brackets in the 314 have been approved under OMB
follows:
• Mail/Hand delivery/Courier (for heading of this document, into the control numbers 0910–0014 and 0910–
written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts 0001, respectively. The collections of
Management Staff (HFA–305), Food and and/or go to the Dockets Management information in 21 CFR 201.56 and
Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061, 201.57 have been approved under OMB
Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852. control number 0910–0572.
• For written/paper comments You may submit comments on any III. Electronic Access
submitted to the Dockets Management guidance at any time (see 21 CFR
Staff, FDA will post your comment, as 10.115(g)(5)). Persons with access to the internet
well as any attachments, except for may obtain the draft guidance at either
Submit written requests for single https://www.fda.gov/Drugs/Guidance
information submitted, marked and copies of the draft guidance to the
identified, as confidential, if submitted ComplianceRegulatoryInformation/
Division of Drug Information, Center for Guidances/default.htm or https://www.
as detailed in ‘‘Instructions.’’ Drug Evaluation and Research, Food
Instructions: All submissions received regulations.gov.
and Drug Administration, 10001 New
must include the Docket No. FDA– Hampshire Ave., Hillandale Building, Dated: October 23, 2017.
2017–D–5912 for ‘‘Pediatric 4th Floor, Silver Spring, MD 20993– Anna K. Abram,
Gastroesophageal Reflux Disease:
0002. Send one self-addressed adhesive Deputy Commissioner for Policy, Planning,
Developing Drugs for Treatment; Draft Legislation, and Analysis.
label to assist that office in processing
Guidance for Industry; Availability.’’
your requests. See the SUPPLEMENTARY [FR Doc. 2017–23436 Filed 10–26–17; 8:45 am]
Received comments will be placed in
INFORMATION section for electronic BILLING CODE 4164–01–P
the docket and, except for those
access to the draft guidance document.
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF HEALTH AND
https://www.regulations.gov or at the Stacy Barley, Center for Drug Evaluation HUMAN SERVICES
Dockets Management Staff between 9 and Research, Food and Drug
a.m. and 4 p.m., Monday through Administration, 10903 New Hampshire Food and Drug Administration
Friday. Ave., Bldg. 75, Rm. 2642, Silver Spring,
• Confidential Submissions: To MD 20993–0002, 301–796–2137. [Docket No. FDA–2017–N–5896]
submit a comment with confidential
SUPPLEMENTARY INFORMATION: Patient-Focused Drug Development:
information that you do not wish to be
Guidance 1—Collecting
made publicly available, submit your I. Background
Comprehensive and Representative
comments only as a written/paper
FDA is announcing the availability of Input; Public Workshop; Request for
submission. You should submit two
a draft guidance for industry entitled Comments
copies total. One copy will include the
information you claim to be confidential ‘‘Pediatric Gastroesophageal Reflux AGENCY: Food and Drug Administration,
with a heading or cover note that states Disease: Developing Drugs for HHS.
‘‘THIS DOCUMENT CONTAINS Treatment.’’ The purpose of this draft
guidance is to assist sponsors in the ACTION: Notice of public workshop;
CONFIDENTIAL INFORMATION.’’ The request for comments.
Agency will review this copy, including clinical development of drugs for the
the claimed confidential information, in treatment of GERD in the pediatric SUMMARY: The Food and Drug
its consideration of comments. The patient population, including guidance Administration (FDA) is announcing a
second copy, which will have the on clinical presentation by age and public workshop to convene a
claimed confidential information disease, study populations, endpoints, discussion on methodological
redacted/blacked out, will be available and pharmacometric issues affecting approaches that a person seeking to
for public viewing and posted on http:// dosing. collect patient experience data for
www.regulations.gov. Submit both This draft guidance is being issued submission to FDA to inform regulatory
copies to the Dockets Management Staff. consistent with FDA’s good guidance decision making may use. The methods
If you do not wish your name and practices regulation (21 CFR 10.115). and approaches would be considered
contact information to be made publicly The draft guidance, when finalized, will relevant and objective, and ensure that
available, you can provide this represent the current thinking of FDA collected data are accurate and
asabaliauskas on DSKBBXCHB2PROD with NOTICES
information on the cover sheet and not on the development of drugs for the representative of the intended
in the body of your comments and you treatment of GERD in the pediatric population, including methods to
must identify this information as patient population. It does not establish collect meaningful patient input
‘‘confidential.’’ Any information marked any rights for any person and is not throughout the drug development
as ‘‘confidential’’ will not be disclosed binding on FDA or the public. You can process and methodological
except in accordance with 21 CFR 10.20 use an alternative approach if it satisfies considerations for data collection,
and other applicable disclosure law. For the requirements of the applicable reporting, management, and analysis.
more information about FDA’s posting statutes and regulations. This guidance This workshop will inform development
of comments to public dockets, see 80 is not subject to Executive Order 12866. of patient-focused drug development
VerDate Sep<11>2014 17:54 Oct 26, 2017 Jkt 244001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\27OCN1.SGM 27OCN1](https://thefederalregister.org/doc/82_FR_50044/page/2.svg)
Document Created: 2017-10-27 02:06:41
Document Modified: 2017-10-27 02:06:41
| 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 December 26, 2017 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Stacy Barley, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 2642, Silver Spring, MD 20993-0002, 301- 796-2137. | |
| FR Citation | 82 FR 49837 |
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