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
Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices 49839 

guidance as required by the 21st 

Century Cures Act (Cures Act), and as 

part of commitments made by FDA 

under the sixth reauthorization of the 

Prescription Drug User Fee Act (PDUFA 

VI). FDA will publish a discussion 

document approximately 1 month 

before the workshop date. FDA is 

interested in seeking information and 

comments on the approaches proposed 

in the discussion document. FDA is also 

interested in input on examples where 

the approaches proposed in the 

discussion document have been 

successfully applied that could be 

illustrated in the draft guidance. 

DATES: The public workshop will be 

held on December 18, 2017, from 9 a.m. 

to 5 p.m. Submit either electronic or 

written comments on this public 

workshop by February 16, 2018. See the 

SUPPLEMENTARY INFORMATION section for 

registration date and information. 

ADDRESSES: The public workshop will 

be held at FDA’s White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503), Silver Spring, MD 20993. 

Entrance for the public workshop 

participants (non-FDA employees) is 

through Building 1 where routine 

security check procedures will be 

performed. For parking and security 

information, please refer to http://

www.fda.gov/AboutFDA/ 

WorkingatFDA/BuildingsandFacilities/ 

WhiteOakCampusInformation/ 

ucm241740.htm. Workshop updates, 

agenda, and discussion document will 

be made available at: https://

www.fda.gov/Drugs/NewsEvents/ 

ucm574725.htm prior to the workshop. 

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 February 16, 2018. The 

https://www.regulations.gov electronic 

filing system will accept comments 

until midnight Eastern Time at the end 

of February 16, 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– 

2017–N–5896 for ‘‘Patient-Focused Drug 

Development: Guidance 1—Collecting 

Comprehensive and Representative 

Input; Public Workshop; 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 

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. 

FOR FURTHER INFORMATION CONTACT: 

Meghana Chalasani, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 1146, 

Silver Spring, MD 20993–0002, 240– 

402–6525, Fax: 301–847–8443, 

Meghana.Chalasani@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

This public workshop is intended to 

support FDA implementation of 

requirements for guidance development 

under section 3002 of the Cures Act and 

to meet a performance goal included in 

the sixth reauthorization of PDUFA VI. 

This reauthorization, part of the FDA 

Reauthorization Act of 2017 (FDARA) 

signed by the President on August 18, 

2017, includes a number of performance 

goals and procedures that are 

documented in the PDUFA VI 

Commitment Letter, which is available 

at https://www.fda.gov/downloads/ 

ForIndustry/UserFees/ 

PrescriptionDrugUserFee/ 

UCM511438.pdf. 

Section 3002 of Title III, Subtitle A of 

the Cures Act directs FDA to develop 

patient-focused drug development 

guidance to address a number of areas 

including under section 3002(c)(1): 

Methodological approaches, which are 

relevant and objective and ensure that 

such data are accurate and 

representative of the intended 

population, that a person seeking to 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
49840 Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices 

collect patient experience data to inform 

regulatory decision making may use. 

In addition, FDA committed to meet 

certain performance goals under PDUFA 

VI. These goal commitments were 

developed in consultation with patient 

and consumer advocates, health care 

professionals, and other public 

stakeholders, as part of negotiations 

with regulated industry. Section J.1 of 

the commitment letter, ‘‘Enhancing the 

Incorporation of the Patient’s Voice in 

Drug Development and DecisionMaking,’’ (https://www.fda.gov/ 

downloads/ForIndustry/UserFees/ 

PrescriptionDrugUserFee/ 

UCM511438.pdf) outlines work, 

including the development of a series of 

guidance documents and associated 

public workshops to facilitate the 

advancement and use of systematic 

approaches to collect and utilize robust 

and meaningful patient and caregiver 

input that can more consistently inform 

drug development, and, as appropriate, 

regulatory decision making. 

Prior to the issuance of each guidance, 

as part of the development, FDA will 

conduct a public workshop to gather 

input from the wider community of 

patients, patient advocates, academic 

researchers, expert practitioners, drug 

developers, and other stakeholders. 

II. Purpose and Scope of Meeting 

FDA is announcing a public 

workshop to convene a discussion on 

topics related to approaches to 

collecting comprehensive and 

representative patient and caregiver 

input on burden of disease and current 

therapy. The purpose of this public 

workshop is to obtain feedback from 

stakeholders on considerations for: (1) 

Standardized nomenclature and 

terminologies for patient-focused drug 

development, (2) methods to collect 

meaningful patient input throughout the 

drug development process, and (3) 

methodological considerations for data 

collection, reporting, management, and 

analysis of patient input. FDA is seeking 

information and comments from a broad 

range of stakeholders, including 

patients, patient advocates, academic 

and medical researchers, expert 

practitioners, drug developers, and 

other interested persons. FDA will 

publish a discussion document 

outlining the topic areas that will be 

addressed in the draft guidance. This 

document will be published 

approximately 1 month before the 

workshop date on the Web site at: 

https://www.fda.gov/Drugs/NewsEvents/ 

ucm574725.htm. FDA is interested in 

seeking information and comments on 

the approaches and considerations 

proposed in the discussion document, 

as well as the examples provided. FDA 

is also interested in seeking information 

and comments on additional examples 

where the approaches proposed in the 

discussion document have been 

successfully applied that could be 

included in guidance. After this public 

workshop, FDA will take into 

consideration the stakeholder input 

from the workshop and the public 

docket, and publish a draft guidance by 

the end of the third quarter of fiscal year 

2018. 

Registration: Interested parties are 

encouraged to register early. To register 

electronically, please visit: https://

pfdd.eventbrite.com. Persons without 

access to the internet can call 240–402– 

6525 to register. If you are unable to 

attend the meeting in person, you can 

register to view a live webcast of the 

meeting. You will be asked to indicate 

in your registration if you plan to attend 

in person or via the webcast. Seating 

will be limited, so early registration is 

recommended. Registration is free and 

will be on a first-come, first-served 

basis. However, FDA may limit the 

number of participants from each 

organization based on space limitations. 

Registrants will receive confirmation 

once they have been accepted. Onsite 

registration on the day of the meeting 

will be based on space availability. 

If you need special accommodations 

because of a disability, please contact 

Meghana Chalasani (see FOR FURTHER

INFORMATION CONTACT) at least 7 days 

before the meeting. 

Request for Oral Presentations: There 

will be time allotted during the 

workshop for open public comment. 

Sign-up for this session will be on a 

first-come, first-serve basis on the day of 

the workshop. Individuals and 

organizations with common interests are 

urged to consolidate or coordinate, and 

request time for a joint presentation. No 

commercial or promotional material 

will be permitted to be presented or 

distributed at the public workshop. 

Transcripts: As soon as a transcript is 

available, FDA will post it at https://

www.fda.gov/Drugs/NewsEvents/ 

ucm574725.htm. 

Dated: October 23, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–23437 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–P–2660] 

Determination That CARDENE SR 

(Nicardipine HCl) Extended-Release 

Capsules, 30 Milligrams, 45 Milligrams, 

and 60 Milligrams, Were Not 

Withdrawn From Sale for Reasons of 

Safety or Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) has 

determined that CARDENE SR 

(nicardipine HCl) extended-release 

capsules, 30 milligrams (mg), 45 mg, 

and 60 mg, were not withdrawn from 

sale for reasons of safety or 

effectiveness. This determination will 

allow FDA to approve abbreviated new 

drug applications (ANDAs) for 

nicardipine HCl extended-release 

capsules, 30 mg, 45 mg, and 60 mg, if 

all other legal and regulatory 

requirements are met. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gottlieb, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6208, 

Silver Spring, MD 20993–0002, 301– 

796–6650. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

(the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products under an 

ANDA procedure. ANDA applicants 

must, with certain exceptions, show that 

the drug for which they are seeking 

approval contains the same active 

ingredient in the same strength and 

dosage form as the listed drug, which is 

a version of the drug that was 

previously approved. ANDA applicants 

do not have to repeat the extensive 

clinical testing otherwise necessary to 

gain approval of a new drug application 

(NDA). 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(j)(7)), which requires FDA to 

publish a list of all approved drugs. 

FDA publishes this list as part of the 

‘‘Approved Drug Products with 

Therapeutic Equivalence Evaluations,’’ 

which is known generally as the Orange 

Book. Under FDA regulations, drugs are 

removed from the list if the Agency 


asabaliauskas on DSKBBXCHB2PROD with NOTICES