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Navigating the PRA for HCD Research

What is the Paperwork Reduction Act (PRA)?

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.

Planning Research

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 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.

Decision Tree: Do I Need Clearance?

Common HCD Research Methods

MethodPRA clearance needed?Rationale
Contextual InquiryNo

Contextual interviews are often non-standardized, conversational, and based on observation. 

The PRA exempts direct observation and non-standardized conversation (5 CFR 1320.3(h)3).

In a Flexibilities under the Paperwork Reduction Act memo it states that “OMB does not generally consider facts or opinions obtained through direct observation by an employee or agent of the sponsoring agency or through non-standardized oral communications in connection with such direct observations to be information under the PRA."

Diary studyNo

If nine or fewer participants the PRA does not apply.

If ten or more participants and the diary is free-form, the PRA does not apply.

If ten or more participants and the diary is structured, the PRA applies.

Field studyNo

Field studies are often non-standardized, conversational, and based on observation.

If nine or fewer participants the PRA does not apply.

If ten or more participants and uses non-standardized conversation and observation, the PRA does not apply.

Focus groupYesAssumes 10 or more participants.
Interview - scriptedYesAssumes 10 or more participants.
Interview - non-standardizedNoNon-standardized questions.

Listening sessions

NoPRA does not apply since discussion and questions at public hearings or meetings are excluded.
Persona - qualitativeNo

If nine or fewer participants the PRA does not apply.

If ten or more participants and uses non-standardized conversation, the PRA does not apply.

Usability study - think aloudNo

Does not require ten or more participants; generally, anything beyond five to eight participants does not yield new information.

A/B testingNoEvaluates potential improvements in comparison to a control version based on statistical analysis.
Card sortingNoPRA exempts direct observation and non-standardized conversations.
Persona - statisticalYesLarge sample size.
Surveys, such as website satisfaction, customer satisfaction, or system usability scaleYes

Large sample size.

Consider the GSA shared service survey resource called Touchpoints that leverages an existing PRA clearance.

Tree testingNo

Tree testing often has 50 or more participants however direct observation and non-standardized conversations are exempt.

Usability study, such as task completion or satisfaction surveyYesLarge sample size.

Generic Information Collections

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)." 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. 

How to Leverage the Fast-Track Generic


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 Research Activities

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

Generic 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.

Generic clearance contact information

Please contact:

  • 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 at who can answer questions about the CIPST generic clearance and provide general reference information.


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. 


How to Use this Information

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. 

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