82 FR 60405 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 82, Issue 243 (December 20, 2017)

Page Range		60405-60406
FR Document		2017-27399

Department of Health and Human Services, The Office of the Secretary (OS), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public to take this opportunity to comment on the ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'' for approval under the Paperwork Reduction Act (PRA). This collection was developed as part of a Federal Government-wide effort to streamline the process for seeking feedback from the public on service delivery. This notice announces our intent to submit this collection to OMB for approval and solicits comments on specific aspects for the proposed information collection.

Federal Register, Volume 82 Issue 243 (Wednesday, December 20, 2017)

[Federal Register Volume 82, Number 243 (Wednesday, December 20, 2017)]
[Notices]
[Pages 60405-60406]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-27399]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Agency Information Collection Activities: Proposed Collection; 
Comment Request; Generic Clearance for the Collection of Qualitative 
Feedback on Agency Service Delivery

AGENCY: U.S. Department of Health and Human Services.

ACTION: 30-Day Day Notice template for Request for Generic Clearance 
for the Collection of Routine Customer Feedback on (HITRC).

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AGENCY: U.S. Department of Health and Human Services (HHS).

ACTION: Notice and request for comments. Office of the National 
Coordinator for Health Information Technology is requesting OMB 
approval for an extension on the Generic Clearance for the Collection 
of Routine Customer Feedback by OMB.

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SUMMARY: Department of Health and Human Services, The Office of the 
Secretary (OS), as part of its continuing effort to reduce paperwork 
and respondent burden, invites the general public to take this 
opportunity to comment on the ``Generic Clearance for the Collection of 
Qualitative Feedback on Agency Service Delivery'' for approval under 
the Paperwork Reduction Act (PRA). This collection was developed as 
part of a Federal Government-wide effort to streamline the process for 
seeking feedback from the public on service delivery. This notice 
announces our intent to submit this collection to OMB for approval and 
solicits comments on specific aspects for the proposed information 
collection.

DATES: Consideration will be given to all comments received by January 
19, 2018.

ADDRESSES: Submit comments by one of the following methods:
     Website: www.regulations.gov. Direct comments to Docket ID 
OMB-2010-0021.
     Email: [email protected].
     Phone: (202) 795-7714.
    Comments submitted in response to this notice may be made available 
to the public through relevant websites. For this reason, please do not 
include in your comments information of a confidential nature, such as 
sensitive personal information or proprietary information. If you send 
an email comment, your email address will be automatically captured and 
included as part of the comment that is placed in the public docket and 
made available on the internet. Please note that responses to this 
public comment request containing any routine notice about the 
confidentiality of the communication will be treated as public comments 
that may be made available to the public notwithstanding the inclusion 
of the routine notice.

FOR FURTHER INFORMATION CONTACT: Sherrette Funn, 
[email protected] or (202) 795-7714.

SUPPLEMENTARY INFORMATION: 
    Title: Generic Clearance for the Collection of Qualitative Feedback 
on Agency Service Delivery.
    Abstract: The proposed information collection activity provides a 
means to 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 
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.
    The solicitation of feedback will target areas such as: Timeliness, 
appropriateness, accuracy of information, courtesy, efficiency of 
service delivery, and resolution of issues with service delivery. 
Responses will be assessed to plan and inform efforts to improve or 
maintain the quality of service offered to the public. If this 
information is not collected, vital feedback from customers and 
stakeholders on the Agency's services will be unavailable.
    The Agency will only submit a collection for approval under this 
generic clearance if it meets the following conditions:
     The collections are voluntary;
     The collections are low-burden for respondents (based on 
considerations of total burden hours, total number of respondents, or 
burden-hours per respondent) and are low-cost for both the respondents 
and the Federal Government;
     The collections are non-controversial and do not raise 
issues of concern to other Federal agencies;

[[Page 60406]]

     Any collection is targeted to the solicitation of opinions 
from respondents who have experience with the program or may have 
experience with the program in the near future;
     Personally identifiable information (PII) is collected 
only to the extent necessary and is not retained;
     Information gathered will be used only internally for 
general service improvement and program management purposes and is not 
intended for release outside of the agency;
     Information gathered will not be used for the purpose of 
substantially informing influential policy decisions; and
     Information gathered will yield qualitative information; 
the collections will not be designed or expected to yield statistically 
reliable results or used as though the results are generalizable to the 
population of study.
    Feedback collected under this generic clearance provides useful 
information, but it does 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 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, 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.
    As a general matter, information collections will not result in any 
new system of records containing privacy information and will not ask 
questions of a sensitive nature, such as sexual behavior and attitudes, 
religious beliefs, and other matters that are commonly considered 
private.
    Current Actions: Extension of approval for a collection of 
information.
    Type of Review: Extension.
    Affected Public: Individuals, households, professionals, public/
private sector.
    Estimated Number of Respondents:
    Below we provide projected average estimates for the next three 
years:
    Average Expected Annual Number of activities: 7.
    Average number of Respondents per Activity: 350.
    Annual responses: 4,158.
    Frequency of Response: Once per request.
    Average minutes per response: 5.
    Burden hours: 1,041.
    Request for Comments: Comments submitted in response to this notice 
will be summarized and/or included in the request for OMB approval. 
Comments are invited on: (a) Whether the collection of information is 
necessary for the proper performance of the functions of the agency, 
including whether the information shall have practical utility; (b) the 
accuracy of the agency's estimate of the burden of the collection of 
information; (c) ways to enhance the quality, utility, and clarity of 
the information to be collected; (d) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques or other forms of information 
technology; and (e) estimates of capital or start-up costs and costs of 
operation, maintenance, and purchase of services to provide 
information. Burden means the total time, effort, or financial 
resources expended by persons to generate, maintain, retain, disclose 
or provide information to or for a Federal agency. This includes the 
time needed to review instructions; to develop, acquire, install and 
utilize technology and systems for the purpose of collecting, 
validating and verifying information, processing and maintaining 
information, and disclosing and providing information; to train 
personnel and to be able to respond to a collection of information, to 
search data sources, to complete and review the collection of 
information; and to transmit or otherwise disclose the information.
    All written comments will be available for public inspection 
Regulations.gov.
    An agency may not conduct or sponsor, and a person is not required 
to respond to, a collection of information unless it displays a 
currently valid Office of Management and Budget control number.

Terry S. Clark,
Asst. Information Collection Clearance Officer.
[FR Doc. 2017-27399 Filed 12-19-17; 8:45 am]
 BILLING CODE 4150-45-P

Federal Register / Vol. 82, No. 243 / Wednesday, December 20, 2017 / Notices 60405

framework for such products (Docket DEPARTMENT OF HEALTH AND this public comment request containing
No. FDA–2015–N–0540; available at HUMAN SERVICES any routine notice about the
https://www.regulations.gov/docket?D= confidentiality of the communication
FDA-2015-N-0540). FDA sought broad Agency Information Collection will be treated as public comments that
public input on its enforcement policies Activities: Proposed Collection; may be made available to the public
related to drug products labeled as Comment Request; Generic Clearance notwithstanding the inclusion of the
homeopathic in an effort to better for the Collection of Qualitative routine notice.
promote and protect the public health. Feedback on Agency Service Delivery FOR FURTHER INFORMATION CONTACT:
AGENCY: U.S. Department of Health and Sherrette Funn, Sherrrette.funn@
As a result of the Agency’s evaluation, HHS.GOV or (202) 795–7714.
including consideration of the public Human Services.
SUPPLEMENTARY INFORMATION:
input received on this issue, FDA has ACTION: 30-Day Day Notice template for
Title: Generic Clearance for the
determined that it is in the best interest Request for Generic Clearance for the
Collection of Qualitative Feedback on
of public health to issue a new guidance Collection of Routine Customer
Agency Service Delivery.
that applies a risk-based enforcement Feedback on (HITRC). Abstract: The proposed information
approach to drug products labeled as AGENCY: U.S. Department of Health and collection activity provides a means to
homeopathic and marketed in the Human Services (HHS). garner qualitative customer and
United States without the required FDA stakeholder feedback in an efficient,
ACTION: Notice and request for
approval, consistent with FDA’s risk- timely manner, in accordance with the
comments. Office of the National
based regulatory approaches generally. Administration’s commitment to
Coordinator for Health Information
The Agency generally intends to apply improving service delivery. By
Technology is requesting OMB approval
a risk-based enforcement approach to qualitative feedback we mean
for an extension on the Generic
the manufacturing, distribution, and information that provides useful
Clearance for the Collection of Routine
marketing of drug products labeled as insights on perceptions and opinions,
Customer Feedback by OMB.
homeopathic, as described in the draft but are not statistical surveys that yield
guidance, when finalized. However, the SUMMARY: Department of Health and quantitative results that can be
Agency has limited enforcement Human Services, The Office of the generalized to the population of study.
Secretary (OS), as part of its continuing This feedback will provide insights into
resources and recognizes that many
effort to reduce paperwork and customer or stakeholder perceptions,
such products likely will fall outside the
respondent burden, invites the general experiences and expectations, provide
risk-based categories described in the an early warning of issues with service,
draft guidance. public to take this opportunity to
comment on the ‘‘Generic Clearance for or focus attention on areas where
This draft guidance is being issued the Collection of Qualitative Feedback communication, training or changes in
consistent with FDA’s good guidance on Agency Service Delivery’’ for operations might improve delivery of
practices regulation (21 CFR 10.115). approval under the Paperwork products or services. These collections
The draft guidance, when finalized, will Reduction Act (PRA). This collection will allow for ongoing, collaborative and
represent the current thinking of FDA was developed as part of a Federal actionable communications between the
on drug products labeled as Government-wide effort to streamline Agency and its customers and
homeopathic. It does not establish any the process for seeking feedback from stakeholders. It will also allow feedback
rights for any person and is not binding the public on service delivery. This to contribute directly to the
on FDA or the public. You can use an notice announces our intent to submit improvement of program management.
The solicitation of feedback will target
alternative approach if it satisfies the this collection to OMB for approval and
areas such as: Timeliness,
requirements of the applicable statutes solicits comments on specific aspects
appropriateness, accuracy of
and regulations. This guidance is not for the proposed information collection.
information, courtesy, efficiency of
subject to Executive Order 12866. DATES: Consideration will be given to all service delivery, and resolution of
comments received by January 19, 2018. issues with service delivery. Responses
II. Electronic Access
ADDRESSES: Submit comments by one of will be assessed to plan and inform
Persons with access to the internet the following methods: efforts to improve or maintain the
may obtain the draft guidance at either • Website: www.regulations.gov. quality of service offered to the public.
https://www.fda.gov/Drugs/Guidance Direct comments to Docket ID OMB– If this information is not collected, vital
ComplianceRegulatoryInformation/ 2010–0021. feedback from customers and
Guidances/default.htm, https:// • Email: stakeholders on the Agency’s services
Information.CollectionClearance@ will be unavailable.
www.fda.gov/BiologicsBloodVaccines/
hhs.gov. The Agency will only submit a
GuidanceComplianceRegulatory
• Phone: (202) 795–7714. collection for approval under this
Information/Guidances/default.htm, or Comments submitted in response to
https://www.regulations.gov. generic clearance if it meets the
this notice may be made available to the following conditions:
Dated: December 6, 2017. public through relevant websites. For • The collections are voluntary;
Leslie Kux, this reason, please do not include in • The collections are low-burden for
Associate Commissioner for Policy. your comments information of a respondents (based on considerations of
confidential nature, such as sensitive
sradovich on DSK3GMQ082PROD with NOTICES

[FR Doc. 2017–27157 Filed 12–18–17; 11:15 am]
total burden hours, total number of
personal information or proprietary respondents, or burden-hours per
BILLING CODE 4164–01–P
information. If you send an email respondent) and are low-cost for both
comment, your email address will be the respondents and the Federal
automatically captured and included as Government;
part of the comment that is placed in the • The collections are non-
public docket and made available on the controversial and do not raise issues of
internet. Please note that responses to concern to other Federal agencies;

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Document Created: 2018-10-25 10:57:28
Document Modified: 2018-10-25 10:57:28

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		30-Day Day Notice template for Request for Generic Clearance for the Collection of Routine Customer Feedback on (HITRC).
Dates		Consideration will be given to all comments received by January 19, 2018.
Contact		Sherrette Funn, [email protected] or (202) 795-7714.
FR Citation		82 FR 60405