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Frequently Asked Questions About PRA / Information Collection

These are some of the most commonly asked questions about the Paperwork Reduction Act (PRA) and the associated clearance process.



Q. What is the Paperwork Reduction Act (PRA) and PRA Clearance?

A. Paperwork Reduction Act (PRA) clearance is the term used for the process of obtaining approval from the Office of Management and Budget (OMB) for federally sponsored data collections as required by the PRA. OMB was originally granted this authority in 1940 under the Federal Reports Act. Due to increasing complaints from the public about duplicate and lengthy federal government data collections, Congress passed the Paperwork Reduction Act (PRA) of 1980 which were reissued in 1995. The purpose of the Act remains to ensure that federal agencies do not overburden the public with federally sponsored data collections. OMB review considerations range from policy issues to statistical design and methodology. OMB pays particular attention to the practical utility of the data to the federal government.  PRA clearance is required when standardized data collection from 10 or more respondents is collected in response to a federally sponsored data collection within a 12 month period.

Many use the term “OMB Clearance”, but since OMB clearance is required for several federal government activities, in order to distinguish OMB Clearance under the PRA, HHS uses the term “PRA Clearance”.  This distinguishes OMB clearance due to the PRA.

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Q. What is meant by “standardized or identical data”?

A. Whether a question is identical depends on whether each respondent or group of respondents (e.g. focus group) is being asked to provide the same level of information on the same subject.  Identical questions need not be phrased exactly the same way each time they are asked, nor does each respondents need to be asked the same “set of questions.”

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Q. How does OMB define “respondents”?

A. A respondent includes individuals; partnerships; associations; corporations; business trusts; legal representatives; organized groups of individuals; and State, territory, tribal or local governments.

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Q. What does “federally sponsored” mean?

A. Data collection is considered federally sponsored when a federal agency:

  1. causes another agency to collect information;
  2. contracts or enters into a cooperative agreement to collect information; or
  3. requires a person to provide information to another person, or otherwise causes another person to obtain, retain, solicit, or require the disclosure to third parties or the public. 

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Q.Can one conduct a data collection without PRA approval if fewer than 10 respondents are involved?

A. The PRA only applies to collections directed at 10 or more respondents, but with one important exception. Any information requirement in a "rule of general applicability" is presumed to affect or potentially affect at least 10 respondents, even if the OPDIV expects there to be fewer respondents. A rule should be considered to have general applicability unless you can demonstrate that it would be impossible for there to ever be 10 respondents.

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QDoesn't the PRA cause more paperwork, not less?

A. For government employees, yes. The objective of the law is to reduce the paperwork burden on the public. The process of trying to do that adds to government paperwork.

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Q. Does the Paperwork Reduction Act apply to collections.....?

...which are voluntary in nature?
...which do not involve any forms (paper)?
...which are conducted over the telephone?
...performed as a part of a focus group or roundtable?
...where only one question is asked?
...which will only be conducted one time?
...which are a part of a pilot project or program?
...which is the result of an Executive Order or Statute?
...which are customer satisfaction surveys (paper or web-based)?

A. The Paperwork Reduction Act is a law and must be complied with regardless of the origin, mode, or reason for the collection.  In accordance with the PRA, OMB approval must be obtained prior to collecting information in any situation where 10 or more respondents are involved and the questions are standardized in nature.

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Q.Does a grant recipient need PRA clearance to conduct surveys?

A. For Grants, there is usually very little federal involvement in the data collection. Therefore, PRA review and clearance may not be needed. However, there are exceptions.  For example, if the federal government specifies a standard reporting mechanism for the grantees, PRA clearance would be required. 

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Q. Does the recipient of a “Cooperative Agreement” need PRA clearance to conduct surveys under the agreement?

A. In Cooperative Agreements, PRA review and approval is required if the OPDIV has significant input/control into the design, methodology, and analysis of the data collection or if the data is stored at the OPDIV level.  Because the need for PRA clearance is dependent on the level of control the government has over the collection, if the need for PRA clearance is not clearly evident, questions about whether a cooperative agreement requires PRA review and approval should be directed to their OPDIV Reports Clearance Officer.

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Q.Do we need PRA clearance for a collection done by a contractor or a state agency?

A. In Contracts, the OPDIV has complete responsibility for the data and data collections procedures. The OPDIV owns the data and it is stored at the OPDIV. Therefore, all data collections performed under contracts need PRA clearance. A collection conducted by a state agency needs clearance if HHS is specifically paying the state to conduct a collection or if HHS must approve a data collection instrument (e.g. a form).

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Q. Does the PRA affect questions at public meetings?

A.  Not usually. No clearance is needed if the attendees are just asked to comment or give suggestions on the program or subject in question. If, however, the group is gathered for the purpose of having attendees respond to a specific set of formatted questions, then the PRA DOESapply.

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Q.Do you need PRA clearance if you just ask people for comments on a document or public comments through the Federal Register?

A. Not unless, respondents are asked to respond to specific questions in their comments.  If the comment is very general, the PRA doesn't apply.  Please note that general public comments can provide limited data and will work well if the program just wants to identify a perceived issue or concern.  However, since the responses are limited to what the respondent wants to share with the requestor, useful unbiased data for use at the policy making or research level cannot be obtained from public comments alone.

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Q. I have a research project and have already obtained IRB Clearance.  Do I also need PRA Clearance?

A. Institutional Review Board (IRB) Clearance and PRA Clearance are 2 separate clearances.  Having one of the two clearances does not negate the need for the other.  In some instances, both clearances are necessary for a research project.  If the research requires standardized data from 10 or more respondents, PRA Clearance will be required.  If the research is clinical in nature, the need for PRA Clearance will have to be reviewed on a case-by-case basis.  PRA Clearance may be partially or fully exempt.  Establish the need for PRA Clearance early in the process.  Projects requiring PRA Clearance that only have IRB Clearance will be considered violations under the PRA.  If the need for clearance is unclear, consult with the OPDIV Reports Clearance Officer for a final determination. 

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Q.Does the PRA affect surveys on the World-Wide-Web?

A. Yes, except PRA clearance is not necessary for very general invitations for public comments and suggestions. The PRA DOESapply if specific questions are asked.

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Q.Do you need PRA clearance if the respondents are foreigners or foreign governments?

A. You need to obtain clearance for any information you gather from foreign citizens or companies. You do not need clearance for information submitted by a foreign government, with one caveat. If a foreign government is required to gather information from its citizens to meet a U.S. requirement (i.e. passports), then PRA clearance is needed.  Refer to the OPDIV Reports Clearance Officer for guidance on the specific situation.

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Q. What is the process for obtaining PRA approval for a collection?

A. The process varies depending on the subject matter of the data collection.  In general, there are four steps to preparing and submitting and information collection request for PRA approval.

Step 1 Prepare and publish a notice in the Federal Register to provide a 60-day period for the public to comment on the reporting and record keeping requirements associated with the information collection.

Step 2 Prepare an information collection request (ICR) package. A complete package should contain the following items in the order listed:

  • Supporting Statement
  • Copies of all the necessary attachments. These attachments can include data collection instruments (questionnaires, surveys, etc.), instructions, scripts, consent forms, IRB letters, and other reference materials related to the collection (e.g., OIG/GAO audits or studies substantiating the need for the collection, copies of documents published as a result of previous collection efforts, etc.)

Step 3 Publish the 30-Day Federal Register Notice and forward the submission to your OPDIV Reports Clearance Officer for review prior to forwarding it through the Department.

Step 4 The Departmental Reports Clearance Officer reviews the collection for quality and potential duplication across the Department prior to forwarding the collection to OMB.

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Q.How long does a PRA clearance take?

A. The complete review and approval process can take anywhere from 6-9 months, depending on the number of requests currently in process and the data collection subject matter.   This estimate includes the 60-day and 30-day public comment periods and the 60 days OMB has to review and act upon each submission.  If the information collection is in a Notice of Proposed Rulemaking (NPRM), please consult with the OPDIV Reports Clearance Officer.  

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Q.Is there any way to speed up the PRA clearance request process?

A. There are provisions in the PRA for emergency processing of ICR packages. Such processing can be done very quickly. Approvals obtained this way are only good for a maximum of 6 months, allowing enough time to obtain approval through the normal process, if necessary. Emergency processing is only to be used to respond to circumstances that could not be foreseen and when the use of regular procedures would result in significant harm to the public or the program. Failure to plan, avoidance of embarrassment, etc., are not valid justifications.  Requests for emergency processing must be approved in advance by the OMB Desk Officer responsible for the OPDIV.  Consult with the OPDIV Reports Clearance Officer.  

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Q. Are there any exemptions to the requirement for OMB review?

A. The PRA exempts certain categories of data collections from the process. However, if you are planning a data collection involving 10 or more respondents in any 12-month period, the need for OMB review should be determined by the OPDIV Reports Clearance Officer.

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Q.Does a form really need to display the burden statement and the OMB number on the approved data collection instrument?

A. Yes, all of this information must be displayed for the respondent.  Ideally, this information should be located on the first page of the data collection instrument or the instructions and/or script.  If spacing is a problem on the form or screen then other considerations, are to include the information on a cover sheet, or keep the OMB number on the first page and add the burden statement to the last page of the form. 

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Q. What is a "Generic Clearance"?

A. A generic clearance obtains OMB approval for a master plan for a number of similar surveys that have the same general purpose (e.g. customer surveys). Individual surveys conducted under the clearance are reviewed by OMB on a fast-track basis and the process involves less documentation. Generic clearances provide more flexibility for certain types of surveys, but they can be harder to track and are not appropriate for many types of information collection efforts.

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Q. What happens if an OPDIV has already conducted a collection for which PRA approval was not obtained? What happens if an OPDIV does not obtain PRA approval for a future collection?

A. The Paperwork Reduction Act is a law and failure to comply with the requirements of the Act is breaking the law. The Chief Information Officer (CIO) is the senior policy official for the Department of Health and Human Services (HHS) responsible for compliance with the law. When OMB becomes aware of a violation of the Paperwork Reduction Act it is brought to the CIO's attention. If the violation is not resolved in a timely manner, the issue is raised in OMB's management chain and can result in official Departmental reprimands and may have budget implications.

If an unapproved collection has already occurred and it is ongoing in nature, the OPDIV should bring the violation to the attention of the Departmental Reports Clearance Officer and work to resolve the violation as soon as possible. If an unapproved collection is conducted and it is a one-time collection, there is no further action that an OPDIV can take to rectify the violation in the short term.

Annually, each OPDIV must submit a summary of information collection activity for the previous fiscal year and a forecast for the coming fiscal year.  This report is included in the annual Information Collection Budget (ICB).  This summary must also include a description of each violation and the action taken, if any, to resolve the issue.

While the consequences of violating the Paperwork Reduction Act do not involve fines or jail sentences, there are legal ramifications to conducting or sponsoring a collection of information without OMB approvals. When a collection occurs without approval, HHS leaves itself open to lawsuits from individuals in the public.

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Q.What happens if I just ignore the law?

A. Unapproved requirements in rules cannot be enforced. You cannot punish anyone for not responding to such a requirement. The only exception is if a law specifically requires the public to submit information. For collections where the response is voluntary, mandatory or required to obtain or retain a benefit, if OMB discovers the collection it will instruct the OPDIV to stop the collection and get clearance.  If the OPDIV ignores this, or develops a record of conducting unapproved collections, OMB has many ways of making the OPDIV regret its behavior.  For example, Federal agencies have experienced a number of instances in which enforcement action was blocked due to deficiencies in the OMB clearance of the information collection.

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Q. I haven’t developed a PRA submission in quite a while.  It appears that some of the guidance I see now contradict previous guidance I had been given.  Has anything changed?

A. It is quite possible. Congress passed a new version of the PRA in 1995, and OMB then issued new regulations. Both the procedures for clearance and the applicability of the Act were changed. So advice or guidance given a few years ago may no longer be valid.  For assistance in developing an ICR, consult with the OPDIV Reports Clearance Officer. 

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Q. What is the Information Collection Budget (ICB)?

A. The Information Collection Budget (ICB) is the vehicle through which OMB, in consultation with each federal agency, sets “annual agency goals to reduce information collection burdens imposed on the public.” The ICB serves as a management oversight tool and as an adjunct to the transactional case-by-case review of agency requests for approval required by the PRA. HHS completes the ICB each year utilizing data collected from the OPDIVs.  

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