Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices 49837 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Dispute Resolution Procedures for 

Science-Based Decisions on Products 

Regulated by CVM—21 CFR Section 

10.75 

OMB Control Number 0910–0566— 

Extension 

CVM’s Guidance for Industry (GIF) 

#79, ‘‘Dispute Resolution Procedures for 

Science-Based Decisions on Products 

Regulated by the Center for Veterinary 

Medicine’’ (https://www.fda.gov/ 

downloads/AnimalVeterinary/ 

GuidanceComplianceEnforcement/ 

GuidanceforIndustry/UCM052393.pdf), 

describes the process by which CVM 

formally resolves disputes relating to 

scientific controversies. A scientific 

controversy involves issues concerning 

a specific product regulated by CVM 

related to matters of technical expertise 

and requires specialized education, 

training, or experience to be understood 

and resolved. The guidance details 

information on how CVM intends to 

apply provisions of existing regulations 

regarding internal review of Agency 

decisions. In addition, the guidance 

outlines the established procedures for 

persons who are sponsors, applicants, or 

manufacturers of animal drugs or other 

products regulated by CVM that wish to 

submit a request for review of a 

scientific dispute. When a sponsor, 

applicant, or manufacturer has a 

scientific disagreement with a written 

decision by CVM, they may submit a 

request for a review of that decision by 

following the established procedures 

discussed in the guidance. 

CVM encourages applicants to begin 

the resolution of science-based disputes 

with discussions with the review team/ 

group, including the Team Leader or 

Division Director. The Center prefers 

that differences of opinion regarding 

science or science-based policy be 

resolved between the review team/group 

and the applicant. If the matter is not 

resolved by this preferred method then 

CVM recommends that the applicant 

follow the procedures in GFI #79. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

10.75, Request for review of a scientific dispute ................ 1 4 4 10 40 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

In the next 3 years, CVM anticipates 

receiving one or fewer requests for 

review of a scientific dispute per year, 

on average. We base our estimate on 

CVM’s experience over the past 6 years 

in handling formal appeals for scientific 

disputes. The burden of this collection 

has changed. The number of 

respondents decreased from two to one 

annually, the number of responses per 

respondent remained at four annually, 

the hours per response remained at 10 

annually, and the total number of hours 

decreased from 80 to 40. This decrease 

in the total hours is the result of a 

natural fluctuation in the number of 

respondents taking advantage of this 

dispute resolution process. 

Dated: October 24, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–23445 Filed 10–26–17; 8:45 am] 

BILLING CODE 4164–01–P 

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. 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
49838 Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices 

• 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.gpo.gov/ 

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/Guidance

ComplianceRegulatoryInformation/

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–5896] 

Patient-Focused Drug Development: 

Guidance 1—Collecting 

Comprehensive and Representative 

Input; Public Workshop; Request for 

Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public workshop to convene a 

discussion on methodological 

approaches that a person seeking to 

collect patient experience data for 

submission to FDA to inform regulatory 

decision making may use. The methods 

and approaches would be considered 

relevant and objective, and ensure that 

collected data are accurate and 

representative of the intended 

population, including methods to 

collect meaningful patient input 

throughout the drug development 

process and methodological 

considerations for data collection, 

reporting, management, and analysis. 

This workshop will inform development 

of patient-focused drug development 


asabaliauskas on DSKBBXCHB2PROD with NOTICES