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addressed in the draft guidance.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
Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices 49841 

withdraws or suspends approval of the 

drug’s NDA or ANDA for reasons of 

safety or effectiveness or if FDA 

determines that the listed drug was 

withdrawn from sale for reasons of 

safety or effectiveness (21 CFR 314.162). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale, but must be made prior to 

approving an ANDA that refers to the 

listed drug (§ 314.161 (21 CFR 314.161)). 

FDA may not approve an ANDA that 

does not refer to a listed drug. 

CARDENE SR (nicardipine HCl) 

extended-release capsules, 30 mg, 45 

mg, and 60 mg, are the subject of NDA 

020005, initially approved on February 

21, 1992. CARDENE SR is indicated for 

the treatment of hypertension. 

In a letter dated September 15, 2014, 

EKR Therapeutics, Inc., requested 

withdrawal of NDA 020005 for 

CARDENE SR (nicardipine HCl) 

extended-release capsules, 30 mg, 45 

mg, and 60 mg. In the Federal Register 

of October 4, 2016 (81 FR 68427), FDA 

announced that it was withdrawing 

approval of NDA 020005, effective 

November 3, 2016. 

Jubilant Generics submitted a citizen 

petition dated April 27, 2017 (Docket 

No. FDA–2017–P–2660), under 21 CFR 

10.30, requesting that the Agency 

determine whether CARDENE SR 

(nicardipine HCl) extended-release 

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

were withdrawn from sale for reasons of 

safety or effectiveness. 

After considering the citizen petition 

and reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that CARDENE SR 

(nicardipine HCl) extended-release 

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

were not withdrawn for reasons of 

safety or effectiveness. The petitioner 

has identified no data or other 

information suggesting that CARDENE 

SR (nicardipine HCl) extended-release 

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

were withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of CARDENE 

SR (nicardipine HCl) extended-release 

capsules, 30 mg, 45 mg, and 60 mg from 

sale. We have also independently 

evaluated relevant literature and data 

for possible postmarketing adverse 

events. We have found no information 

that would indicate that this drug 

product was withdrawn from sale for 

reasons of safety or effectiveness. 

Accordingly, the Agency will 

continue to list CARDENE SR 

(nicardipine HCl) extended-release 

capsules, 30 mg, 45 mg, and 60 mg, in 

the ‘‘Discontinued Drug Product List’’ 

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

delineates, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. ANDAs that refer 

to CARDENE SR (nicardipine HCl) 

extended-release capsules, 30 mg, 45 

mg, or 60 mg, may be approved by the 

Agency as long as they meet all other 

legal and regulatory requirements for 

the approval of ANDAs. If FDA 

determines that labeling for this drug 

product should be revised to meet 

current standards, the Agency will 

advise ANDA applicants to submit such 

labeling. 

Dated: October 24, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–23438 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–2014–N–0487] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Generic Clearance 

for the Collection of Qualitative 

Feedback on Agency Service Delivery 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by November 

27, 2017. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, Fax: 202– 

395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0697. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Generic Clearance for the Collection of 

Qualitative Feedback on Agency 

Service Delivery 

OMB Control Number 0910–0697— 

Extension 

The information collection activity 

will garner qualitative customer and 

stakeholder feedback in an efficient, 

timely manner in accordance with the 

Administration’s commitment to 

improving service delivery. By 

qualitative feedback we mean 

information that provides useful 

insights on perceptions and opinions, 

but are not statistical surveys that yield 

quantitative results that can be 

generalized to the population of study. 

This voluntary feedback will provide 

insights into customer or stakeholder 

perceptions, experiences and 

expectations, provide an early warning 

of issues with service, or focus attention 

on areas where communication, 

training, or changes in operations might 

improve delivery of products or 

services. These collections will allow 

for ongoing, collaborative, and 

actionable communications between the 

Agency and its customers and 

stakeholders. It will also allow feedback 

to contribute directly to the 

improvement of program management. 

Feedback collected under this generic 

clearance will provide useful 

information, but it will not yield data 

that can be generalized to the overall 

population. This type of generic 

clearance for qualitative information 

will not be used for quantitative 

information collections that are 

designed to yield reliably actionable 

results, such as monitoring trends over 

time or documenting program 

performance. Such data uses require 

more rigorous designs that address the 

following: The target population to 

which generalizations will be made, the 

sampling frame, the sample design 

(including stratification and clustering), 

the precision requirements or power 

calculations that justify the proposed 

sample size, the expected response rate, 


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