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Indian Health Manual

Chapter 34 - Information Collection Clearance

Part 5 - Management Services

Title	Section
Introduction	5-34.1
Purpose	5-34.1A
Authorities	5-34.1B
Policy	5-34.1C
Scope	5-34.1D
Responsibilities	5-34.2
Director, IHS	5-34.2A
Director, Office of Management Services	5-34.2B
Director, Division of Regulatory Affairs	5-34.2C
Information Collection Clearance Officer	5-34.2D
Employees	5-34.2E
Information or Information Collection	5-34.3
Information Collection Clearance Process	5-34.3A
Information or Information Collection	5-34.3B
General Procedures to Obtain Clearance for a Regular ICR	5-34.3D
Fast Track Generic Information Collection Clearance Process	5-34.3D
Approved Information Collection Requests	5-34.3E
Information Collection and Paperwork Reduction Act Website	5-34.3F

Exhibit	Description
Manual Exhibit 5-34-A,	OMB Meorandum, "Information Collection under the Paperwork Reduction Act," dated April 7, 2010
Manual Exhibit 5-34-B,	OMB Memorandum "New Fast-Track Process for Collecting Service Delivery Feedback under the Paperwork Reduction Act," dated June 15, 2011
Manual Exhibit 5-34-C,	OMB Memorandum "Paperwork Reduction Act - Generic Clearances," dated May 28, 2010
Manual Exhibit 5-34-D,	OMB Memorandum, "Reducing Reporting and Paperwork Burdens," dated June 22, 2012
Manual Exhibit 5-34-E,	OMB Memorandum, "Social Media, Web-Based Interactive Technologies, and the Paperwork Reduction Act," dated April 7, 2010
Manual Exhibit 5-34-F,	"How to Write a Supporting Statement Parts A & B"
Manual Exhibit 5-34-G,	Request for Approval under the "Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery" OMB Control Number 0917-0036-XX
Manual Exhibit 5-34-H,	Exclusions to the regulatory definition of "information" under Paperwork Reduction Act (September 5, 2014)

5-34.1 Introduction

Purpose. This chapter establishes the protocol for Indian Health Service (IHS) employees to obtain clearance for the collection of information from the public in compliance with the Paperwork Reduction Act (PRA) of 1995, Public Law No. (Pub. L.) 104-13, as amended, and its implementation in 5 Code of Federal Regulations (C.F.R.) § 1320.

Authorities.
1. "Controlling Paperwork Burdens on the Public," 5 C.F.R. § 1320. http://www.gpo.gov/fdsys/pkg/CFR-2010-title5-vol3/xml/CFR-2010-title5-vol3-part1320.xml
2. OMB Circular A-130, "Management of Federal Information Resources" http://www.whitehouse.gov/omb/circulars_a130_a130trans4/
3. OMB Memorandum, "Information Collection under the Paperwork Reduction Act," dated April 7, 2010. (Manual Exhibit 5-34-A )
4. 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 )
5. OMB Memorandum "Paperwork Reduction Act - Generic Clearances," dated May 28, 2010. (Manual Exhibit 5-34-C)
6. OMB Memorandum, "Reducing Reporting and Paperwork Burdens," dated June 22, 2012. (Manual Exhibit 5-34-D)
7. OMB Memorandum, "Social Media, Web-Based Interactive Technologies, and the Paperwork Reduction Act." dated April 7, 2010. (Manual Exhibit 5-34-E)
8. "Paperwork Reduction Act of 1995," Pub. L. No. 104-13. http://www.gpo.gov/fdsys/pkg/PLAW-104publ13/pdf/PLAW-104publ13.pdf
9. "Coordination of Federal Information Policy," 44 United States Code (U.S.C.) § 3502. http://www.gpo.gov/fdsys/pkg/USCODE-2011-title44/pdf/USCODE-2011-title44-chap35.pdf

Policy. IHS employees are required by the PRA, and related regulations, to comply with this Policy. Also, IHS management officials shall incorporate the terms of this Policy into contractor personnel, interns, and other non-government employees' contracts or memorandums of agreement as conditions for their employment. It is 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 sufficiently independent of program responsibility to evaluate fairly whether proposed information collections should be approved.
3. Publish notices in the Federal Register describing proposed information collections and soliciting comment from the public prior to requesting most types of information from the public.
4. Submit proposed information collections, prior to use, for review and approval to the Office of the Chief Information Officer (OCIO), Department of Health and Human Services (HHS) and the Office of Information and Regulatory Affairs (OIRA), Office of Management and Budget (hereafter referred to as OMB) for approval.
5. Receive approval from OMB, before commencing the proposed information collection.
6. Report to OMB all information collections conducted in violation of the PRA's provisions, and the progress of initiatives to reduce information collection burden.

Scope. This information collection policy applies to all IHS staff and to organizations conducting business for and on behalf of the IHS through contractual relationships, cooperative 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

Director, IHS. The Director, IHS, is responsible for designating responsibilities as listed under 5 C.F.R. §1320.7. The Director, IHS, also reviews and provides clearance for the 60-Day and 30-Day Federal Register notices for regular Information Collection Requests (ICR). Agency approval for collections of information to be submitted to OMB for review can only be authorized by the Director, IHS, or her or his designee.
The Director, IHS, or designee, may request an emergency processing of a submission of an information collection to OMB, via the IHS Information Collection Clearance Office, DRA, OMS, in accordance with 5 C.F.R. § 1320.13. This may include situations where public harm is reasonably likely to result if normal clearance procedures are followed, and/or an unanticipated event has occurred.

Director, Office of Management Services. The Director, OMS, is designated by the Director, IHS, as the Senior Official responsible for, but not limited to, the following in accordance with 5 C.F.R. § 1320.7:
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.
2. With respect to the collection of information, the Director, OMS, shall establish a process within the IHS that is sufficiently independent of program responsibility to evaluate fairly whether the proposed collections of information should be approved.

Director, Division of Regulatory Affairs. The Director, Division of Regulatory Affairs (DRA), is responsible for:
1. Ensuring all IHS staff/programs are in compliance with the PRA regulations, including reporting violations to OMB (i.e., IHS employees collecting information without prior approval from OMB).
2. Ensuring coordination with the regulatory process.

Information Collection Clearance Officer. The Information Collection Clearance Officer (ICCO) position is located within the DRA. The ICCO has primary responsibility for evaluating proposed ICRs for compliance with the PRA prior to submission to 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 IHS staff with navigating the information collection clearance process for preparing and submitting ICR packages for approval. These duties include:
  1. Responds to inquiries from IHS staff regarding the information collection clearance process.
  2. Assists IHS staff with creating new or revising existing supporting statements.
  3. Assists IHS staff to prepare or revise, and submit 60-day and 30-day Federal Register notices to the Federal Register for publication.
  4. Reviews and ensures information collection instruments (i.e., forms and surveys) are in compliance with PRA regulations.
  5. Submits the information collection packages, on behalf of IHS staff, to HHS and OMB for approval.
3. Develops the IHS information collection clearance policy, procedures, and guidance for implementing the PRA provisions and regulations.

Employees. All IHS employees are responsible for:
1. Consulting with the IHS ICCO to ensure the correct information and documents are provided to obtain approval from OMB prior to use of the information collection instruments (i.e., forms or surveys).
2. Complying with the provisions of the PRA and OMB regulations.
3. Using only information collection instruments (i.e., forms and surveys) that are approved by OMB to collect information from the public.

5-34.3 INFORMATION OR INFORMATION COLLECTION

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 Information Collection Request; or
2. Fast track Generic Information Collection Request (G-ICR).

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 C.F.R. § 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, 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's 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. A 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.
    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 OMB.
2. Definition of "Collection of Information." Pursuant to 44 U.S.C. § 3502(3)(A)(i); 5 C.F.R. § 1320.3(c), "collection of information" means using identical questions posed to, or reporting or recordkeeping requirements imposed on, "ten or more persons." Such collections of information may be mandatory, voluntary, or required to obtain or retain a benefit, including 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), "person" means: "An individual, partnership, association, corporation, 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 ten 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 OMB approval.
  2. The "ten 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 OMB [5 C.F.R. § 1320.3(c)(4)].
4. Surveys of any kind (i.e., a Survey Monkey), and the use of social media (i.e., 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).
5. If Federal employees wish to collect information from Tribal employees, or other non-Federal persons, they must obtain prior OMB approval.
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 OMB.
7. The Tribal Consultation process, as delineated by the IHS Tribal Consultation Policy, IHS Circular No. 2006-1, is not considered an information collection, as defined by the PRA. OMB regulations specify a number of items that are generally not considered "information" under the PRA [5 C.F.R. 1320.3(h) (4), (6), and (8)], including facts or opinions that are:
  1. submitted in response to general solicitations of public comments,
  2. addressed to a single person, and
  3. obtained or solicited at or in connection with public hearings or meetings [see 5-34.3, B. (1) h].

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, OCIO, HHS, and OMB on behalf of IHS staff/programs, for further review and final approval. See "Guidance for Completing an Information Collection" found at the HHS OCIO Internet website at: http://www.hhs.gov/ocio/policy/collection/infocolsub.html.
  1. Program staff shall begin to prepare a new regular ICR package at least 6 to 9 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 4 to 6 months prior to the expiration date of the existing OMB approved collection.
2. Regular ICR Package. The sponsoring program staff is required to 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 C.F.R. § 1320.8(d)]. The DRA will assist 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 OMB for final review and approval. This process provides the public an opportunity to provide further comment for another 30 days. [44 U.S.C. 3507(a)(1)(D); 5 C.F.R. § 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 OMB and informs the public 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.
  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.

Fast Track Generic Information Collection Clearance Process. In May 2012, IHS obtained 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 (i.e., 2-4 weeks) to obtain 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 OMB:
  1. The purpose of the collection is to assist the Agency/program in improving existing or future service deliveries, products, or communication materials;
  2. Participation by respondents is voluntary;
  3. The collection does not impose a significant burden on respondents;
  4. The collection does not require statistical rigor in order to have practical utility for improving existing or future service deliveries, products, or communication materials; and
  5. Public dissemination of results is not intended.
2. As a general matter, the following kinds of collections may fall under the fast track G-ICR process:
  1. Comment cards or complaint forms;
  2. Focus groups;
  3. One-time or panel discussion groups;
  4. Moderated, un-moderated, in-person, and/or remote-usability studies;
  5. Testing of a survey or other collection to refine questions;
  6. Post-transaction customer surveys (e.g., by call centers);
  7. On-line surveys; and
  8. Customer satisfaction qualitative surveys (e.g., those designed to detect early warning signs of dissatisfaction with agency service delivery).
3. 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).
  2. The information collections instrument (i.e., survey, forms).
4. The ICCO submits the fast track G-ICR package to OCIO, HHS, and OMB, on behalf of the program, for approval.

Approved Information Collection Requests. With both the regular ICR and the fast track G-ICR, the ICCO will notify the requesting program office of 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 OMB control number assigned for the collection.
2. The burden statement (See Manual Exhibit 5-34-F, for more information on burden hours).

Information Collection Request and Paperwork Reduction Act Website. The DRA created an ICR and PRA intranet website to provide IHS employees with guidance in preparing an ICR. Employees can access the laws, regulations, OMB memorandums, and procedures mentioned in this policy on the website address at: http://home.ihs.gov/PRA/index.cfm?module=home