The Paperwork Reduction Act (PRA) is a federal law intended to ease the data reporting burden imposed by the government. The law pertains to data collection regardless of form or format (including digital, paper-based, and standardized interviews). The PRA governs most research and feedback collection mechanisms done by or on behalf of the federal government. Any federal agency requesting responses from the public is required to estimate the time and cost burden for citizens to respond and the burden on the federal agency to compile and synthesize the data. Authorizations for PRA approval of data collection come from the Office of Management and Budget (OMB), and PRA officers in each agency coordinate the effort.

It is essential and mandatory that CCSQ comply with the PRA when applying human-centered design (HCD) processes and methodologies. However, the PRA should not limit HCD best practices to improve the customer experience. If the information you are collecting is subject to clearance, most agencies estimate six to nine months from agency development to approval. We encourage you to take advantage of the flexibilities and requirements that exist for compliance. You can learn more about the basic information related to the PRA at A Guide to the Paperwork Reduction Act.

About the PRA and HCD

PRA Flexibilities

Compliance requires an understanding of when the PRA applies. Generally, if you collect the same information from ten or more people or entities within 12 months, the PRA applies. Applicable members of the public governed by the PRA are vast. It includes individuals (including non-US citizens), businesses and associations, non-federal and foreign governments, and more. Ultimately, the only excluded individuals or groups are within the federal government and military (and even then, the PRA can sometimes be applicable).

However, there are many exclusions to when the PRA applies, such as: 

• Generally, requesting the same information from fewer than ten people. There are some exceptions to this rule.
• Direct observation, such as qualitative usability tests and field studies.
• Open-ended requests for comments or feedback.
• Discussions and questions at public hearings or meetings (whether in person or online).
• Collecting information from federal employees related to their role or function.

Your research objectives, target users, protocols, and timeframes play an essential role in determining which research method(s) you will implement. That, in turn, determines whether the PRA applies. The number of people needed to complete a study for insight generation may be under the PRA threshold or because a technique is not subject to the PRA since it employs direct observation and non-standardized conversation. 

For example, with human-centered design (HCD), the goal is to understand people (end-users and other stakeholders) and their interactions with everything or a particular product or service during their daily lives. If that is your goal, you may select observational and ethnographic research methods to learn about people to extract valuable insights from the research. The PRA may not apply since exclusions include direct observation and non-standard oral communication, which is the essence of ethnographic research.

Ultimately, the number of participants depends on what researchers need to know, the purpose of the inquiry, the business problem, what lends credibility to the study, and available resources. There are best practices you can apply as a rule of thumb to begin research in some instances. Some studies will require more individuals and some fewer.

Navigating HCD and PRA

Navigating HCD Research and PRA is a summary document that can help you determine if the PRA applies to your study. It includes high-level steps to get started, HCD research methods and PRA quick reference guide, and a decision tree to help you understand if you need clearance. The job aid is a general reference and should not be confused with official guidance from the Office of Strategic Operations and Regulatory Affairs (OSORA). Always follow your group’s guidelines about research and PRA guidelines.

Do I Need Clearance?

Common Methods

Generic clearances go through the normal PRA process (such as the 60-day and 30-day notices to the Federal Register) but allow quicker clearance of future collections, which leverage it.

Some generic clearances also include the fast-track process, which means collections usually do not have to undergo additional public comment and involve less documentation and time to obtain approval. Instead, in most situations, OMB completes its review within five business days after receiving all required materials.

CCSQ Generic Clearance

In July 2021, CCSQ's Information Systems Group (ISG) obtained OMB approval for an information collection request (ICR) titled "Generic Clearance for the Center for Clinical Standards and Quality IT Product and Support Teams (CMS-10706)" (OMB Control Number: 0938-1397)." In July of 2024, this clearance was renewed and the capacity for respondents and hours was expanded. This clearance is for the Center for Clinical Standards and Quality IT Product and Support Teams (CIPST) to leverage for specific information collections and includes the Fast-Track approval process. 

Fast-Track Requests

Criteria

The generic fast-track requests are for teams that collect data on stakeholder awareness, understanding, attitudes, preferences, or experiences about existing or future products or services. An information collection may be eligible if it meets all the following criteria:

• The data collection focuses on improving existing or future services or products.
• The collection is voluntary. 
• The collection is a low burden for respondents and low-cost for the Federal Government.
• The collection is non-controversial and does not raise issues of concern to other federal agencies.
• There is no dissemination of the findings to the public.           
• Information gathered will not be used to inform policy decisions substantially.

Example Methods

HCD research methods that inform the utility, usability, and desirability of products or services are generally appropriate for the generic clearance. Examples include:

• Card Sorting 
• Cognitive Testing
• Field Studies
• First Click Tests
• Focus Groups
• Participatory Design
• Surveys
• Tree Testing
• User Interviews
• Usability Testing

Fast Track Process

First, some quick tips:

• Give yourself sufficient lead time for approval, including up to a month after all materials are with OMB.
• If you are unsure if the collection is appropriate for the generic fast track, contact OSORA.
• You may also refer to the checklist job aid to help you understand if your collection is likely a good fit for the generic fast track. 
• If you are a contractor, coordinate with your CMS point of contact to interface with OSORA, including any questions you may have and submission of the short-form ICR template. 

Critical steps to follow and what to expect:

1. Prepare: Submit the following to OSORA for a fast-track generic ICR clearance package:
   1. A completed short-form ICR template.
   2. A copy of the information collection instruments and research artifacts, e.g., research plan, survey, questions, etc.
   3. Include the PRA Disclosure Statement on all collection instruments.
   4. Submit the ICR package to OSORA; if you are a contractor, coordinate with your CMS point of contact to submit the package to OSORA.
2. OSORA review: OSORA will review the ICR package and suggest changes if needed.
   1. Complete any requested changes and send revised documents to OSORA in collaboration with your CMS point of contact.
   2. OSORA will submit the ICR package to OMB. 
3. OMB review: OMB has five business days to respond; however, you should plan for a month before receiving approval. 
   1. OSORA will contact you if OMB has a question or requires more information.
   2. If OMB inquires within those five days, they have an additional five days to respond after sending them your response via OSORA.
   3. Typically an ICR is assumed to be approved after 5 days with no response from OMB, however OSORA will allow additional time to receive OMB guidance.
4. Information collection: OSORA will contact you with approval to proceed. 

OSORA has indicated that generally, OMB will have a question, and in practice, it may take longer than five days. While approval will not take as long as a regular (non-generic, non-fast track) package, it may be longer than five days. A month is a reasonable amount of time to expect, so be sure to give yourself sufficient lead time.

This information is meant to be for general reference and should not be confused with official guidance from Office of Strategic Operations and Regulatory Affairs (OSORA). Always follow your group’s guidelines about research and PRA guidelines. 

• Office of Strategic Operations and Regulatory Affairs (OSORA), who is the primary contact and subject matter expert for the PRA. If you are a contractor, coordinate your outreach with OSORA via your CMS point of contact. Note: the hyperlink is for CMS employees to access information for Regulatory and Affairs Group.
• CCSQ HCD Center of Excellence, who can answer general questions about PRA. We can also provide consult if you think you are eligible to Fast Track your research using the Generic Clearance for the Center for Clinical Standards and Quality IT Product and Support Teams (CMS-10706).

Please reach out to the HCD Center of Excellence if you have any questions about the information on this page or general questions about the PRA and the CCSQ generic clearance. 

CMS-10706 Generic Clearance

Generic Clearance Checklist - Use this job aid to help determine if your ICR is appropriate for the CCSQ generic clearance with fast track process.

Short form - ICR template - Use this form to capture the details of your ICR for OSORA and OMB review.

PRA Disclosure Statement - All collection instruments submitted under this generic fast track must include this statement.

CMS-10706 Package - View OMB's published information (OMB Control No: 0938-1397) for the "Generic Clearance for the Center for Clinical Standards and Quality IT Product and Support Teams (CMS-10706)", including active research projects.

Job Aids

Navigating HCD Research and PRA - A job aid outlining basics about the PRA, common HCD research methods, and a decision tree.

Fast-Track Generic Checklist - Use this job aid to help determine if your ICR is appropriate for the CCSQ generic clearance with fast track process.

Guides

Guide to the Paperwork Reduction Act  - A plain language guide that answers the most common questions to the PRA.

18F User Experience Design Guide - 18F, a government design agency, shares their understanding of the PRA and HCD methods.

Memos

FAQs About Fast Track - Published in 2012, this document answers common questions about the fast track process.

Flexibilities Under the PRA - A memo outlining many administrative flexibilities available to assist agencies in complying with their obligations under the PRA.

Exclusions to Regulatory Definition of Information - A summary table of exclusions to the PRA.

OSORA and OMB

OSORA - The Office of Strategic Operations and Regulatory Affairs includes PRA officers who coordinate PRA efforts for the agency. Note: the above link is for CMS employees to access information for Regulatory and Affairs Group.

OIRA - The Office of Information and Regulatory Affairs (OIRA) is a statutory part of the Office of Management and Budget within the Executive Office of the President.

Information Collection Inventory - OIRA listing of current collections, collections under review, and more.

Shared Services

Touchpoints - A GSA service that provides a standard feedback survey template that leverages an existing PRA clearance.