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withdrawn from sale for reasons of 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a listed drug was withdrawn from sale 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time after the drug has been withdrawn 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were withdrawn from sale for reasons of 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were not withdrawn for reasons of 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were withdrawn for reasons of safety or 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, 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
49842 Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices 

methods for assessing potential nonresponse bias, the protocols for data 

collection, and any testing procedures 

that were or will be undertaken prior to 

fielding the study. Depending on the 

degree of influence the results are likely 

to have, such collections may still be 

eligible for submission for other generic 

mechanisms that are designed to yield 

quantitative results. 

In the Federal Register of June 15, 

2017 (82 FR 27508), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Focus groups ........................................................... 800 1 800 1.75 ............................ 1,400 

Customer comment cards/forms ............................. 1,325 1 1,325 0.25 (15 minutes) ....... 331.25 

Small discussion groups .......................................... 800 1 800 1.75 ............................ 1,400 

Customer satisfaction surveys ................................ 12,000 1 12,000 0.33 (20 minutes) ....... 3,960 

Usability studies ....................................................... 800 1 800 1.75 ............................ 1,400 

Total .................................................................. ........................ ........................ ........................ .................................... 8,491.25 

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

Dated: October 24, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–23443 Filed 10–26–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Committee on Vital and Health 

Statistics: Teleconference 

Pursuant to the Federal Advisory 

Committee Act, the Department of 

Health and Human Services (HHS) 

announces the following Subcommittee 

meetings of the National Committee on 

Vital and Health Statistics to be held 

virtually. 

Name: National Committee on Vital 

and Health Statistics (NCVHS), Virtual 

Meetings of the Subcommittee. 

Dates and Times: 

NCVHS Population Health 

Subcommittee; Tuesday, November 

28, 2017: 9:00 a.m.—1:00 p.m. ET 

NCVHS Privacy, Confidentiality, and 

Security Subcommittee; Tuesday, 

November 28, 2017: 1:30 p.m.—5:30 

p.m. ET 

NCVHS Standards Subcommittee; 

Wednesday, November 29, 2017: 1:00 

p.m.—5:00 p.m. ET 

Place: WebEx/teleconference—To 

participate in the virtual meeting, please 

use the following URL http://

www.ncvhs.hhs.gov/ that points to the 

NCVHS homepage. Further information 

and meeting agendas will be available 

on the NCVHS Web site including 

instructions for accessing the live 

meeting broadcast. 

Status: Open by WebEx/ 

teleconference. There will be an open 

comment period during the final 10 

minutes of each of the three virtual 

meetings where the public can provide 

comments via the WebEx on-line 

meeting interface. Written comments 

may also be provided to the Executive 

Secretary at the contact information 

provided below. 

Purpose: The NCVHS virtual meeting 

of the Population Health Subcommittee 

will convene to discuss: (1) Follow up 

work on the NCVHS September 11–12, 

2017 Next Generation Vital Statistics 

Hearing, including the draft hearing 

report and follow up analyses being 

conducted on the Committee’s behalf, 

and; (2) topics and projects to be 

considered for the 2018 workplan. 

The NCVHS virtual meeting of the 

Privacy, Confidentiality and Security 

Subcommittee will convene to discuss a 

draft environmental scan report of the 

health information privacy and security 

landscape in the U.S. that extends 

beyond HIPAA. This will include 

formal presentations from invited 

experts to further inform the draft 

environmental scan research being 

conducted on the Committee’s behalf. 

The agenda also will include discussion 

of privacy-related topics under 

consideration for the 2018 workplan. 

The NCVHS virtual meeting of the 

Standards Subcommittee will convene 

to consider the Subcommittee’s 

workplan and high level milestones for 

three possible projects in 2018: (1) A 

Chief Information Officer (CIO) Forum; 

(2) the challenge of patient 

identification and matching for 

healthcare providers and patients; and 

(3) potential guidance pertaining to the 

prior authorization transaction. In 

addition, CMS will provide a briefing to 

the Subcommittee on the New Medicare 

Card Project. 

For more Information Contact: 

Substantive program information may 

be obtained from Rebecca Hines, MHS, 

Executive Secretary, NCVHS, National 

Center for Health Statistics, Centers for 

Disease Control and Prevention, 3311 

Toledo Road, Hyattsville, Maryland 

20782, telephone (301) 458–4715. 

Summaries of meetings and a roster of 

Committee members are available on the 

NCVHS Web site: http://

www.ncvhs.hhs.gov/, where further 

information including an agenda and 

instructions to access the broadcast of 

the meeting will be posted. 

Dated: October 23, 2017. 

Laina Bush, 

Deputy Assistant Secretary for Planning and 

Evaluation, Office of the Assistant Secretary 

for Planning and Evaluation. 

[FR Doc. 2017–23358 Filed 10–26–17; 8:45 am] 

BILLING CODE 4151–05–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

[Docket No. USCG–2016–1059] 

Towing Safety Advisory Committee; 

December 2017 Meeting 

AGENCY: U.S. Coast Guard, Department 

of Homeland Security. 

ACTION: Notice of Federal Advisory 

Committee meeting. 

SUMMARY: The Towing Safety Advisory 

Committee and its Subcommittees will 

meet in New Orleans, Louisiana to 

review and discuss recommendations 

from its Subcommittees and to receive 

briefs on items listed in the agenda 

under SUPPLEMENTARY INFORMATION. All 

meetings will be open to the public. 

DATES:

Meetings. The Subcommittees of the 

Towing Safety Advisory Committee will 


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