Chapter 34 - Paperwork Reduction Act – Information Collections Policy

5-34.1  INTRODUCTION

1. Purpose. This chapter establishes the policy of the Indian Health Service (IHS) intended to ensure compliance with the Paperwork Reduction Act (PRA) of 1995, Public Law No. (Pub. L.) 104-13, as amended; the implementing regulations in Title 5, Section 1320 of the Code of Federal Regulations (CFR); and the Office of Management and Budget (OMB) and the Department of Health and Human Services (HHS or the Department) policies, standards, procedures, and instructions with regard to clearance of information collections. The chapter provides a protocol plan for the development of proposed collections of information, including new information collections and the extension of ongoing collections, to allow for public comment, Department certification and OMB review. The chapter also provides protocols on collaboration with Area contacts and the Agency Information Collection Clearance Officer (ICCO) to timely and officially submit the information collection to HHS ICCO. Lastly the chapter sets forth the responsibilities to produce and approve notices for publication in the Federal Register.

   This policy outlines the protocols for programs and employees to follow to obtain clearance for the collection of information from the public in compliance with the PRA.

2. Authorities.
   1. Controlling Paperwork Burdens on the Public,” 5 CFR § 1320. Exit Disclaimer: You Are Leaving www.ihs.gov 
   2. OMB Memorandum, “Information Collection under the Paperwork Reduction Act,” dated April 7, 2010.  (Manual Exhibit 5-34-A)
   3. OMB Memorandum “New Fast-Track Process for Collecting Service Delivery Feedback under the Paperwork Reduction Act,” dated June 15, 2011.  (Manual Exhibit 5-34-B)
   4. OMB Memorandum “Paperwork Reduction Act – Generic Clearances,” dated May 28, 2010.  (Manual Exhibit 5-34-C)
   5. OMB Memorandum, “Reducing Reporting and Paperwork Burdens,” dated June 22, 2012.  (Manual Exhibit 5-34-D)
   6. OMB Memorandum, “Social Media, Web-Based Interactive Technologies, and the Paperwork Reduction Act.” dated April 7, 2010. (Manual Exhibit 5-34-E)
   7. Paperwork Reduction Act of 1995, Pub. L. No. 104-13, codified as revised at Sections 3501-3521 of Title 44, United States Code (U.S.C.).
3. Policy.  Federal Agencies must comply with the PRA.  All IHS employees are required to comply with the PRA and related regulations, and follow this policy.  In addition, where applicable, IHS staff should ensure compliance by organizations conducting business for and on behalf of the IHS.  It is the IHS policy to:
   1. Establish an office for ensuring compliance with and prompt, efficient, and effective implementation of the PRA’s provisions;
   2. Establish a process within that office that is sufficiently independent of program responsibility and to evaluate fairly whether the proposed information collection(s) should be approved;
   3. Publish notices in the Federal Register describing the proposed information collections and soliciting comment from the public prior to requesting most types of information from the public, which is a requirement of the OMB;
   4. Submit proposed information collections, prior to use, for review and approval to the Office of the Chief Information Officer (OCIO), HHS and the Office of Information and Regulatory Affairs, OMB for approval;
   5. Receive approval from the OMB before commencing the proposed information collection(s); and
   6. Report to the OMB all information collections conducted in violation of the PRA’s provisions and the progress of initiatives and efforts of the Agency to reduce information collection burden.
4. Scope.  This information collections policy applies to all IHS staff and, where applicable, requires IHS staff ensure compliance by organizations conducting business for and on behalf of the IHS through contractual relationships, collaborative agreements, and, in some cases, grants.  This policy does not supersede any other applicable law or higher-level agency directive or policy guidance.

5-34.2  RESPONSIBILITIES

1. Director, IHS.  The Director, IHS, encourages all staff to stay abreast of information collections trainings and other important Agency-wide notices.  The Director, IHS, reviews and provides Agency clearance for the 60-Day and 30-Day Federal Register notices for regular Information Collection Requests (ICR).  Agency approval for regular collections of information to be submitted to the OMB for review will be coordinated through HHS after approval by the Director, IHS, or designee, via the IHS ICCO, Division of Regulatory and Policy Coordination (DRPC), Office of Management Services (OMS), in accordance with 5 CFR § 1320.

   Through HHS, the Director, IHS, or designee, may request an emergency processing of a submission of an information collection to the OMB, via the IHS ICCO, DRPC, OMS, in accordance with 5 CFR § 1320.13.  This may include situations where public harm is reasonably likely to result if normal clearance procedures are followed, an unanticipated event has occurred, or for the other reasons delineated in 5 CFR § 1320.13.

2. Area Directors.  Area Directors must designate an Area Point of Contact (POC) within the Area to work with the ICCO.  This role will be provided additional guidance, training and understanding of the PRA and act as a local POC to ensure all Area staff have resources, training, and secondary reviews before sending information to the ICCO.  The POC will send information collections to the ICCO for review and clearance.  The Area Directors will:
   1. Establish and appoint an Area POC for information collections, and submit this to the Director, DPRC within 45 days of approval of this policy.  Additionally, the POC must be updated in the event of any changes, and will be verified annually with the ICCO;
   2. Ensure staff is in compliance with the PRA regulations, including reporting violations to the ICCO (i.e., IHS employees collecting information without prior approval from the OMB); and
   3. Following the coordination processes with this policy.
3. Director, Office of Management Services.  The Director, OMS, is responsible for, but not limited to, the following:
   1. Ensuring Agency compliance with and prompt, efficient, and effective implementation of the information policies and information resources management responsibilities established under the PRA, including the reduction of information collection burdens on the public; and
   2. Establishing a process within the IHS that is sufficiently independent of program responsibility to evaluate fairly whether the proposed collections of information should be approved, with respect to the collection of information.
4. Director, Division of Regulatory and Policy Coordination.  The Director, DRPC, is responsible for:
   1. Confirming Area Directors have appointed an Area POC for information collections, and that all Headquarters (HQ) IHS staff/programs are aware they must be in compliance with the PRA regulations, including reporting violations to the OMB (i.e., IHS employees collecting information without prior approval from the OMB); and
   2. Ensuring coordination with the regulatory process.
5. Information Collection Clearance Officer.  The ICCO position is located within the DRPC.  The ICCO has primary responsibility for evaluating proposed ICR’s for compliance with the PRA prior to submission through HHS to the OMB for approval.  The ICCO responsibilities include, but are not limited to:
   1. Acts as a liaison between IHS staff and the OCIO, HHS, and OMB.
   2. Assists the IHS Area POC and HQ staff with navigating the information collections clearance process for preparing and submitting ICR packages for approval.  These duties include:
      1. Responding to inquiries from the IHS Area POCs and staff regarding the information collection clearance process;
      2. Providing guidance to the IHS Area POCs and staff with creating new or revising existing supporting statements;
      3. Providing guidance to IHS staff to prepare or revise, and submit 60-day and 30-day Federal Register notices to the Federal Register for publication;
      4. Reviewing and ensuring information collection instruments (i.e., forms and surveys) are in compliance with PRA regulations;
      5. Submitting the information collections packages, on behalf of IHS staff, to HHS for review and submission to the OMB for approval; and
      6. Coordinating responses to the OMB questions.
   3. Develops and maintains the IHS information collection clearance policy, procedures, and guidance for implementing the PRA provisions and regulations.
6. Employees.  All IHS employees are responsible for:
   1. Consulting with the Area POC, and/or the IHS ICCO to determine if the PRA/OMB clearance is required, and to ensure  the correct information and documents are provided to obtain approval from the OMB prior to use of the information collection instruments (i.e., surveys);
   2. Complying with the provisions of the PRA and OMB regulations; and
   3. Using only information collection instruments (i.e., surveys) that are approved by the OMB to collect information from the public.
   4. Generally, if Federal employees wish to collect information from Tribal employees, or other non-Federal persons, they must obtain prior OMB approval.  See 5-34.3B for relevant definitions and potentially relevant exceptions

5-34.3  INFORMATION OR INFORMATION COLLECTION

1. Information Collection Clearance Process.  The overall process of preparing, evaluating, and obtaining approval to collect information from the public is referred to as the information collection clearance process.  The information collection clearance process varies depending on a number of variables, including whether an ICR is categorized as either a:
   1. Regular ICR; or
   2. Fast track Generic Information Collection Request (G-ICR).
2. Information, Information Collection, and related items.  Generally, the terms “information” and “collection of information” are defined as follows (See Manual Exhibit 5-34-H for more information about information exclusions):
   1. Definition of “Information.”  Pursuant to 5 CFR § 1320.3(h), “Information” means any statement or estimate of fact or opinion, regardless of form or format, whether in numerical, graphic, or narrative form, and whether oral or maintained on paper, electronic or other media.  “Information” does not generally include items in the following categories; however, the OMB may determine that any specific item constitutes “information”:
      1. Affidavits, oaths, affirmations, certifications, receipts, changes of address, consents, or acknowledgments; provided that they entail no burden other than that necessary to identify the respondent, the date, the respondent's address, and the nature of the instrument (by contrast, a certification would likely involve the collection of information” if an agency conducted or sponsored it as a substitute for a collection of information to collect evidence of, or to monitor, compliance with regulatory standards, because such a certification would generally entail burden in addition to that necessary to identify the respondent, the date, the respondent address, and the nature of the instrument);
      2. Samples of products or of any other physical objects;
      3. Facts or opinions obtained through direct observation by an employee or agent of the sponsoring agency or through non?standardized oral communication in connection with such direct observations;
      4. Facts or opinions submitted in response to general solicitations of comments from the public, published in the Federal Register or other publications, regardless of the form or format thereof, provided that no person is required to supply specific information pertaining to the commenter, other than that necessary for self?identification, as a condition of the agency's full consideration of the comment;
      5. Facts or opinions obtained initially or in follow-on requests, from individuals (including individuals in control groups) under treatment or clinical examination in connection with research on or prophylaxis to prevent a clinical disorder, direct treatment of that disorder, or the interpretation of biological analyses of body fluids, tissues, or other specimens, or the identification or classification of such specimens;
      6. Request for facts or opinions addressed to a single person;
      7. Examinations designed to test the aptitude, abilities, or knowledge of the persons tested and the collection of information for identification or classification in connection with such examinations;
      8. Facts or opinions obtained or solicited at or in connection with public hearings or meetings;
         1. If, however, the group is gathered for the purpose of having attendees respond to a specific set of formatted questions, then the PRA does apply;
         2. No clearance is needed if the attendees are just asked to comment or give suggestions on the program or subject in question; and
         3. It follows that agencies may offer the public opportunities to provide general comments on discussion topics through the Internet (Manual Exhibit 5-35-A).
      9. Facts or opinions obtained or solicited through non-standardized follow-up questions designed to clarify responses to approved collections of information; and
      10. Like items so designated by the OMB.
   2. Definition of “Collection of Information.”  As further detailed in 44 U.S.C. § 3502(3); 5 CFR § 1320.3(c), “collection of information” includes, but is not limited to, using identical questions posed to, or identical reporting or recordkeeping requirements imposed on, “ten or more persons.”  Regardless of form or format and regardless of whether it is mandatory, voluntary, or required to obtain or retain a benefit, such collections of information may include but not limited to:
      1. Requests for information to be sent to the government, such as forms (e.g., scholarship application), written reports (e.g., grantee performance reports), and surveys (e.g., trainee or patient satisfaction surveys);
      2. Recordkeeping requirements (e.g., as required by some contracts); and
      3. Third-party or public disclosures (e.g., nutrition labeling requirements for food).
   3. Definition of “person.”  Pursuant to 44 U.S.C. § 3502(10); 5 CFR § 1320.3(k), “person” means:  “An individual, partnership, association, corporation (including operations of government-owned contractor-operated facilities), business trust, or legal representative, an organized group of individuals, a state, territorial, Tribal, or local government or branch thereof, or a political subdivision of a state, territory, Tribal, or local government or a branch of a political subdivision.”
      1. Where the agency initiates an identical information request over a 12-month period to the same group of persons, the sum of the persons queried, regardless of whether the same person is queried more than one time, must be used to count the total persons for the purposes of being considered 10 or more persons.  For example, where the agency sends the same information request to five persons quarterly over the course of a 12-month period, each person will be counted four times, for a total of 20 persons.  That information collection must seek the OMB approval.
      2. The “10 or more persons” does not generally apply to Federal employees, when acting within the scope of their employment.  Therefore, Federal employees may collect information (e.g., via a survey) from other Federal employees without obtaining prior approval from the OMB, unless the answers are to be used for general statistical purposes [44 U.S.C. § 3502(3)(A)(ii); 5 CFR § 1320.3(c)(3)-(4)].
   4. Definition of “the public.”  People or groups outside of the Federal government.  Federal employees and military personnel are not considered the public under the PRA.
   5. Surveys of any kind (e.g., a SurveyMonkey), and the use of social media (e.g., Facebook) and other web-based interactive technologies, that pose identical, specific questions (including through pop-up windows), are considered collections of information (See Manual Exhibit 5-34-E for more information).  These types of information may also need a Third Party Web Application Privacy Impact Assessment approval through HHS.  The ICCO will inform contacts if such information needs additional approvals.
   6. The ICCO should always be consulted in situations where it is planned for a contractor to conduct an information collection from the public, on behalf of the IHS operated program, as this activity may still need approval by the OMB.
   7. The Tribal Consultation process, as delineated by the IHS Tribal Consultation Policy, IHS Circular No. 2006-1, is not considered information collection, as defined by the PRA.  The OMB regulations specify a number of items that are generally not considered “information” under the PRA [5 CFR 1320.3(h) (4), (6), and (8)], including facts or opinions that are:
      1. Submitted in response to general solicitations of public comments, published in the Federal Register or other publications;
      2. Addressed to a single person; and
      3. Obtained or solicited at or in connection with public hearings or meetings.
3. General Procedures to Obtain Clearance for a Regular ICR.
   1. Clearance Process.  A regular ICR clearance process refers to the type of ICR clearance process typically used, since the OMB PRA regulations were promulgated, as opposed to a fast track G-ICR.  The ICR package must be submitted to the ICCO for review and approval.  The ICCO will submit the ICR package to the Director, IHS.  Once approved by the Director, IHS, the ICCO will submit the ICR package to the OCIO, HHS for review, and HHS will then submit the ICR package to the OMB, on behalf of the IHS staff/programs, for further review and final approval.
      1. Program staff will begin to prepare a new regular ICR package at least one (1) year to 18 months prior to the target date the program expects to begin collecting information from the public.
      2. Program staff planning to renew an existing ICR shall begin the renewal process at least nine (9) months to one (1) year prior to the expiration date of the existing OMB approved collection.
   2. Regular ICR Package.  The sponsoring program is the office of record, and the program staff is required to keep track of the timelines, prepare a regular ICR package to obtain approval for their collection and it must contain the following:
      1. Supporting Statement.  The OMB requires Federal agencies to submit a supporting statement to provide justification, background material and supporting analysis for the collection.  The supporting statement includes a Part A, and may require a Part B.  Contact the ICCO for examples of the Supporting Statement (See Manual Exhibit 5-34-F, titled “How to Write a Supporting Statement Parts A & B”).
         1. Part A is a detailed discussion of the need, use, burden hours, costs, and methodology of the information collection.
         2. Part B may be required in addition to Part A, for information collections involving statistical sampling (such as surveys and questionnaires used to make inferences about a population from a subset of that population).
      2. 60-Day Federal Register Notice.  The PRA requires the Agency to publish a 60-day notice in the Federal Register to solicit public comment on the agency's proposed collection [44 U.S.C. 3506(c)(2)(A); 5 CFR § 1320.8(d)].  The DRPC will provide guidance to the program to prepare and publish a Federal Register notice to provide a 60-day period for the public to comment on the proposed information collection.
         1. The entire content of the ICR package (with the exception of the 30-day Federal Register notice) must be drafted by the time the first comment period starts so it can be supplied to members of the public upon request.
         2. The notice must include a specific request that the public evaluate whether the proposed collection of information is necessary; evaluate the accuracy of the agency’s estimate of the burden the collection would impose on respondents; comment on how to enhance the quality, utility, and clarity of the information to be collected; and comment on how to minimize the burden of the collection of information.
         3. The program that originated the ICR is responsible for responding to any public comments received in response to the 60-day notice.
         4. The entire package (Supporting Statement, 60-Day Federal Register notice, and information collection instrument) must be submitted to the ICCO who will route it through the proper channels to the Director, IHS, for clearance.  The Director, IHS, approves the 60-Day Federal Register notice, and then it is submitted to the Federal Register for publication.
      3. 30-Day Federal Register Notice.  After conclusion of the 60-day comment period, the ICCO channels the ICR package with a 30-Day Federal Register notice through the appropriate review channels to the Director, IHS, for clearance, again.  Once the 30-day Federal Register notice is published in the Federal Register, the ICCO submits the ICR package to the OMB for final review and approval.  This process lets the public know that the ICR package was submitted to the OMB and provides the public an opportunity to provide further comment for another 30 days, which are sent to the OMB instead. [Pursuant to 44 U.S.C. 3507(a)(1)(D); 5 CFR § 1320.10(a)].
         1. The comments and responses resulting from the published 60-day Federal Register notice are included within the 30-day Federal Register notice.
         2. The requesting program may revise the ICR based on the public comments received during the 60-day period.
         3. The 30-day Federal Register notice, which is the second notice, informs the public about how to submit comments to the OMB and informs the public the OMB may act on the Agency's request only after the 30-day comment period has closed.
      4. Data collection instruments.  Data instruments include but are not limited to:  questionnaires, surveys, instructions, scripts, and consent forms with information subject to PRA. There are many types of consent forms.  All consent forms should be sent to the ICCO for review if they impact members of the public.  They may also need review by the agency Privacy Officer.
      5. Other relevant materials related to the collection.  Other relevant materials, include for example, studies substantiating the need for the collection or copies of documents published as a result of previous collection efforts, etc.
   3. Common Form clearance and Emergency/Expedited review and clearance (used in very limited cases).  Both clearances must be discussed with the ICCO.
4. Fast Track Generic Information Collection Clearance Process.  The IHS obtained the OMB approval for an umbrella ICR titled “Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery” (OMB No. 0917-0036).  The fast track G-ICR clearance process involves much less documentation, and less time to obtain the OMB approval than a regular ICR.
   1. IHS staff that plan to use similar information collection instruments (i.e., customer satisfaction surveys) may be allowed to submit their ICR under this expedited process, if it meets all of the following criteria, as mandated by the OMB:
      1. The 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;
      2. The information gathered will not be used for the purpose of substantially informing influential policy decisions;
      3. The 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;
      4. The collections are voluntary;
      5. 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;
      6. The collections are non-controversial and do not raise issues of concern to other Federal agencies;
      7. 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; and
      8. With the exception of information needed to provide remuneration for participants of focus groups and cognitive laboratory studies, personally identifiable information is collected only to the extent necessary and is not retained. 
   2. As a general matter, the following kinds of collections may fall under the fast track G-ICR process:
      1. Customer comment cards/complaint forms.
      2. Small discussion groups.
      3. Focus groups of customers, potential customers, delivery partners, or other stakeholders.
      4. Cognitive laboratory studies, such as those used to refine questions or assess usability of a website.
      5. Qualitative customer satisfaction surveys (e.g., post-transaction surveys; opt-out web surveys).
      6. In-person observation testing (e.g., website or software usability tests).
   3. The Area POC, and HQ IHS staff must submit the following items to the ICCO for a fast track G-ICR clearance package:
      1. A completed short form (2 pages), titled “Generic Clearance Submission Template” (also known as the mini-supporting statement).  Contact the IHS ICCO for this template form, and examples (See Manual Exhibit 5-34-G); and
      2. The information collections instrument (i.e., survey, forms).
   4. The ICCO submits the fast track G-ICR package to the OCIO, HHS, and OMB, on behalf of the program, for approval.
5. Approved Information Collection Requests.  With both the regular ICR and the fast track G-ICR, the ICCO will notify the requesting program office of the OMB’s approval or disapproval.  Once the form is approved, the following information must be displayed on the information collection instrument (i.e., form or survey) whenever it is used.
   1. The OMB approval information with an OMB control number assigned for the collection.
   2. The burden statement (See Manual Exhibit 5-34-F, for more information on burden hours).
6. Information Collection Request and Paperwork Reduction Act Website.  The DRPC created an ICR and PRA intranet website to provide IHS employees with guidance in preparing an ICR.  Employees can access the laws, regulations, resources, and procedures mentioned in this policy on the website address at:  https://home.ihs.gov/PRA/index.cfm?module=home