82 FR 49841 - 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
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 | 49841-49842 | |
| FR Document | 2017-23443 |
[Federal Register Volume 82, Number 207 (Friday, October 27, 2017)] [Notices] [Pages 49841-49842] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-23443] ----------------------------------------------------------------------- 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 [email protected]. 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, [email protected]. 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, [[Page 49842]] methods for assessing potential non-response 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\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Activity Number of responses per Total annual Average burden per response Total hours respondents respondent responses -------------------------------------------------------------------------------------------------------------------------------------------------------- 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 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There 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
![Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices 49841
withdraws or suspends approval of the Accordingly, the Agency will in brackets in the heading of this
drug’s NDA or ANDA for reasons of continue to list CARDENE SR document.
safety or effectiveness or if FDA (nicardipine HCl) extended-release FOR FURTHER INFORMATION CONTACT:
determines that the listed drug was capsules, 30 mg, 45 mg, and 60 mg, in Amber Sanford, Office of Operations,
withdrawn from sale for reasons of the ‘‘Discontinued Drug Product List’’ Food and Drug Administration, Three
safety or effectiveness (21 CFR 314.162). section of the Orange Book. The White Flint North, 10A–12M, 11601
A person may petition the Agency to ‘‘Discontinued Drug Product List’’ Landsdown St., North Bethesda, MD
determine, or the Agency may delineates, among other items, drug 20852, 301–796–8867, PRAStaff@
determine on its own initiative, whether products that have been discontinued
a listed drug was withdrawn from sale fda.hhs.gov.
from marketing for reasons other than
for reasons of safety or effectiveness. safety or effectiveness. ANDAs that refer SUPPLEMENTARY INFORMATION: In
This determination may be made at any to CARDENE SR (nicardipine HCl) compliance with 44 U.S.C. 3507, FDA
time after the drug has been withdrawn extended-release capsules, 30 mg, 45 has submitted the following proposed
from sale, but must be made prior to mg, or 60 mg, may be approved by the collection of information to OMB for
approving an ANDA that refers to the Agency as long as they meet all other review and clearance.
listed drug (§ 314.161 (21 CFR 314.161)). legal and regulatory requirements for Generic Clearance for the Collection of
FDA may not approve an ANDA that the approval of ANDAs. If FDA Qualitative Feedback on Agency
does not refer to a listed drug. determines that labeling for this drug
CARDENE SR (nicardipine HCl) Service Delivery
product should be revised to meet
extended-release capsules, 30 mg, 45 current standards, the Agency will OMB Control Number 0910–0697—
mg, and 60 mg, are the subject of NDA advise ANDA applicants to submit such Extension
020005, initially approved on February labeling.
21, 1992. CARDENE SR is indicated for The information collection activity
the treatment of hypertension. Dated: October 24, 2017. will garner qualitative customer and
In a letter dated September 15, 2014, Anna K. Abram, stakeholder feedback in an efficient,
EKR Therapeutics, Inc., requested Deputy Commissioner for Policy, Planning, timely manner in accordance with the
withdrawal of NDA 020005 for Legislation, and Analysis. Administration’s commitment to
CARDENE SR (nicardipine HCl) [FR Doc. 2017–23438 Filed 10–26–17; 8:45 am] improving service delivery. By
extended-release capsules, 30 mg, 45 BILLING CODE 4164–01–P
qualitative feedback we mean
mg, and 60 mg. In the Federal Register information that provides useful
of October 4, 2016 (81 FR 68427), FDA insights on perceptions and opinions,
announced that it was withdrawing DEPARTMENT OF HEALTH AND but are not statistical surveys that yield
approval of NDA 020005, effective HUMAN SERVICES quantitative results that can be
November 3, 2016. generalized to the population of study.
Jubilant Generics submitted a citizen Food and Drug Administration This voluntary feedback will provide
petition dated April 27, 2017 (Docket insights into customer or stakeholder
[Docket No. FDA–2014–N–0487]
No. FDA–2017–P–2660), under 21 CFR perceptions, experiences and
10.30, requesting that the Agency Agency Information Collection expectations, provide an early warning
determine whether CARDENE SR Activities; Submission for Office of of issues with service, or focus attention
(nicardipine HCl) extended-release Management and Budget Review; on areas where communication,
capsules, 30 mg, 45 mg, and 60 mg, Comment Request; Generic Clearance training, or changes in operations might
were withdrawn from sale for reasons of for the Collection of Qualitative improve delivery of products or
safety or effectiveness. Feedback on Agency Service Delivery services. These collections will allow
After considering the citizen petition for ongoing, collaborative, and
and reviewing Agency records and AGENCY: Food and Drug Administration, actionable communications between the
based on the information we have at this HHS. Agency and its customers and
time, FDA has determined under ACTION: Notice. stakeholders. It will also allow feedback
§ 314.161 that CARDENE SR to contribute directly to the
(nicardipine HCl) extended-release SUMMARY: The Food and Drug improvement of program management.
capsules, 30 mg, 45 mg, and 60 mg, Administration (FDA) is announcing Feedback collected under this generic
were not withdrawn for reasons of that a proposed collection of clearance will provide useful
safety or effectiveness. The petitioner information has been submitted to the information, but it will not yield data
has identified no data or other Office of Management and Budget that can be generalized to the overall
information suggesting that CARDENE (OMB) for review and clearance under population. This type of generic
SR (nicardipine HCl) extended-release the Paperwork Reduction Act of 1995. clearance for qualitative information
capsules, 30 mg, 45 mg, and 60 mg, DATES: Fax written comments on the will not be used for quantitative
were withdrawn for reasons of safety or collection of information by November information collections that are
effectiveness. We have carefully 27, 2017. designed to yield reliably actionable
reviewed our files for records ADDRESSES: To ensure that comments on results, such as monitoring trends over
concerning the withdrawal of CARDENE the information collection are received, time or documenting program
asabaliauskas on DSKBBXCHB2PROD with NOTICES
SR (nicardipine HCl) extended-release OMB recommends that written performance. Such data uses require
capsules, 30 mg, 45 mg, and 60 mg from comments be faxed to the Office of more rigorous designs that address the
sale. We have also independently Information and Regulatory Affairs, following: The target population to
evaluated relevant literature and data OMB, Attn: FDA Desk Officer, Fax: 202– which generalizations will be made, the
for possible postmarketing adverse 395–7285, or emailed to oira_ sampling frame, the sample design
events. We have found no information submission@omb.eop.gov. All (including stratification and clustering),
that would indicate that this drug comments should be identified with the the precision requirements or power
product was withdrawn from sale for OMB control number 0910–0697. Also calculations that justify the proposed
reasons of safety or effectiveness. include the FDA docket number found sample size, the expected response rate,
VerDate Sep<11>2014 17:54 Oct 26, 2017 Jkt 244001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 E:\FR\FM\27OCN1.SGM 27OCN1](https://thefederalregister.org/doc/82_FR_50048/page/1.svg)
![49842 Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices
methods for assessing potential non- to have, such collections may still be 60-day notice requesting public
response bias, the protocols for data eligible for submission for other generic comment on the proposed collection of
collection, and any testing procedures mechanisms that are designed to yield information. No comments were
that were or will be undertaken prior to quantitative results. received.
fielding the study. Depending on the In the Federal Register of June 15, FDA estimates the burden of this
degree of influence the results are likely 2017 (82 FR 27508), FDA published a collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response
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
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 24, 2017. minutes of each of the three virtual be obtained from Rebecca Hines, MHS,
Anna K. Abram, meetings where the public can provide Executive Secretary, NCVHS, National
Deputy Commissioner for Policy, Planning, comments via the WebEx on-line Center for Health Statistics, Centers for
Legislation, and Analysis. meeting interface. Written comments Disease Control and Prevention, 3311
[FR Doc. 2017–23443 Filed 10–26–17; 8:45 am] may also be provided to the Executive Toledo Road, Hyattsville, Maryland
BILLING CODE 4164–01–P Secretary at the contact information 20782, telephone (301) 458–4715.
provided below. Summaries of meetings and a roster of
Purpose: The NCVHS virtual meeting Committee members are available on the
DEPARTMENT OF HEALTH AND of the Population Health Subcommittee NCVHS Web site: http://
HUMAN SERVICES will convene to discuss: (1) Follow up www.ncvhs.hhs.gov/, where further
work on the NCVHS September 11–12, information including an agenda and
National Committee on Vital and Health 2017 Next Generation Vital Statistics instructions to access the broadcast of
Statistics: Teleconference Hearing, including the draft hearing the meeting will be posted.
report and follow up analyses being Dated: October 23, 2017.
Pursuant to the Federal Advisory
conducted on the Committee’s behalf, Laina Bush,
Committee Act, the Department of
and; (2) topics and projects to be
Health and Human Services (HHS) Deputy Assistant Secretary for Planning and
considered for the 2018 workplan. Evaluation, Office of the Assistant Secretary
announces the following Subcommittee The NCVHS virtual meeting of the
meetings of the National Committee on for Planning and Evaluation.
Privacy, Confidentiality and Security [FR Doc. 2017–23358 Filed 10–26–17; 8:45 am]
Vital and Health Statistics to be held Subcommittee will convene to discuss a
virtually. draft environmental scan report of the
BILLING CODE 4151–05–P
Name: National Committee on Vital health information privacy and security
and Health Statistics (NCVHS), Virtual landscape in the U.S. that extends
Meetings of the Subcommittee. beyond HIPAA. This will include DEPARTMENT OF HOMELAND
Dates and Times: formal presentations from invited SECURITY
NCVHS Population Health experts to further inform the draft
Subcommittee; Tuesday, November Coast Guard
environmental scan research being
28, 2017: 9:00 a.m.—1:00 p.m. ET conducted on the Committee’s behalf. [Docket No. USCG–2016–1059]
NCVHS Privacy, Confidentiality, and The agenda also will include discussion
Security Subcommittee; Tuesday, of privacy-related topics under Towing Safety Advisory Committee;
November 28, 2017: 1:30 p.m.—5:30 consideration for the 2018 workplan. December 2017 Meeting
p.m. ET The NCVHS virtual meeting of the AGENCY: U.S. Coast Guard, Department
NCVHS Standards Subcommittee; Standards Subcommittee will convene of Homeland Security.
Wednesday, November 29, 2017: 1:00 to consider the Subcommittee’s ACTION: Notice of Federal Advisory
p.m.—5:00 p.m. ET workplan and high level milestones for Committee meeting.
Place: WebEx/teleconference—To three possible projects in 2018: (1) A
participate in the virtual meeting, please Chief Information Officer (CIO) Forum; SUMMARY: The Towing Safety Advisory
use the following URL http:// (2) the challenge of patient Committee and its Subcommittees will
meet in New Orleans, Louisiana to
asabaliauskas on DSKBBXCHB2PROD with NOTICES
www.ncvhs.hhs.gov/ that points to the identification and matching for
NCVHS homepage. Further information healthcare providers and patients; and review and discuss recommendations
and meeting agendas will be available (3) potential guidance pertaining to the from its Subcommittees and to receive
on the NCVHS Web site including prior authorization transaction. In briefs on items listed in the agenda
instructions for accessing the live addition, CMS will provide a briefing to under SUPPLEMENTARY INFORMATION. All
meeting broadcast. the Subcommittee on the New Medicare meetings will be open to the public.
Status: Open by WebEx/ Card Project. DATES:
teleconference. There will be an open For more Information Contact: Meetings. The Subcommittees of the
comment period during the final 10 Substantive program information may Towing Safety Advisory Committee will
VerDate Sep<11>2014 17:54 Oct 26, 2017 Jkt 244001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\27OCN1.SGM 27OCN1](https://thefederalregister.org/doc/82_FR_50048/page/2.svg)
Document Created: 2017-10-27 02:06:34
Document Modified: 2017-10-27 02:06:34
| 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. | |
| Dates | Fax written comments on the collection of information by November 27, 2017. | |
| 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, [email protected] | |
| FR Citation | 82 FR 49841 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR