Departmental Procedures for Review of Information Collection Requests

Introduction

As described in Circular Number IRM-402, OPDIVs are responsible for ensuring OPDIV compliance with OMB and Departmental directives; planning for the development of new collections of information and the extension of ongoing collections well in advance to allow for public comment, Departmental certification, and OMB review; conducting independent reviews of proposed information collections; preparing and submitting to the Department their information collection clearance packages for submission to OMB; providing to the Department the necessary certifications for paperwork clearances; producing and approving notices for publication in the Federal Register; managing the OPDIV burden reduction program; and developing and managing their Information Collection Budget.

The OPDIV Chief Information Officer should be involved in Paperwork Reduction Act review activities and be fully cognizant of all issues arising from the collection of information from the public. OPDIVs bear the responsibility of demonstrating in their information collection clearance packages that they have taken all reasonable steps to reduce reporting burden on the public, covering the topics of burden estimation, burden reduction for small entities, frequency of response, response time, number of copies required, writing in plain language, and consistency with existing reporting and recordkeeping practices. Each OPDIV must also prepare its Information Collection Budget as a management oversight tool to serve as an adjunct to the case-by-case management of its information collection requests.

Excluding the time involved developing the information collection clearance request, the entire Paperwork Reduction Act renewal process may take as long as five to six months. Four months are needed as follows: first Federal Register notice - 60 days, second Federal Register notice - 30 days, and OMB review - 30 days. Therefore, OPDIVs must manage the process (excluding true emergencies) to ensure that the first Federal Register notice is published five months before OMB approval is needed. The two public comment periods and the "public protection" provision of the PRA require that OPDIVs allow adequate time to ensure that OMB approvals do not lapse and become in violation of the law.

OPDIVs should use the Paperwork Reduction Act (P.L. 104-13), OMB regulations (5 CFR Part 1320), and the Draft OMB Implementing Guidance as references for meeting the above requirements.

1. Clearance Requests to the Department
   1. Paperwork Reduction Act Submission Packages

      A major change arising from the 1995 revision to the PRA is the requirement that the Department take a more active role in reviewing information collection requests before the requests are submitted to OMB. Hence, OPDIVs must now submit all clearance requests to the Department for departmental review and certification prior to OMB review. Normally, the Department will send the requests to OMB in 10 working days or less.

      The Department requires three copies of the clearance request package: one copy for Departmental records and two copies for OMB.

      Each PRA clearance request package must contain the following:

      1. Form OMB 83-I, as certified by the OPDIV Senior Information Collection Official. The OPDIV certifies the form's contents (item 19 of the 83-I) to the Department and the Department, in turn, must certify the contents to OMB. Exhibit A of these procedures contains instructions for completing Form OMB 83-I. The form and procedures are also available at web site: www.hhs.gov/oirm/infocollect.

      2. A Supporting Statement, fully completed, that describes in details the nature of the information collection. Exhibit B of these guidelines provides instructions for preparing the Supporting Statement. These guidelines are also available at web site: www.hhs.gov/oirm/infocollect.

      3. 60-Day Advance Federal Register Notice. With the exception of Information Collection requirements contained in proposed rules, OPDIVs must publish a 60-day advance notice in the Federal Register. A copy of this notice should be included with the PRA clearance request. The notice must solicit public comment on the need for the information, its practical utility, the accuracy of the OPDIV's burden estimate, and ways to minimize burden (including applications of information technology). The 60-day notice directs public comment to the OPDIV. The OPDIV must include a copy of the 60-day notice in its PRA clearance request package. In preparing the 60-day notice, the OPDIV should exercise care that numerical estimates are consistent throughout the package. For additional information on preparing the 60-day notice, consult OMB's draft Implementing Guidance.

      4. Draft 30-Day Federal Register Notice. At the end of the 60-day comment period, the OPDIV should prepare a second Federal Register notice in draft, notifying the public that the clearance request was submitted to OMB and requesting public comment be directed to OMB. The OPDIV should include the draft 30-day notice in the clearance request package. The draft 30-day notice should reflect any burden changes that resulted from the first public comment period. Before forwarding the clearance request package to OMB, the Department will notify the OPDIV upon completion of its review of the clearance package. Generally, after Departmental notification, the OPDIV will send the 30-day notice to the Federal Register for publication. OMB's draft Implementing Guidance contains specifications for the contents of the draft 30-day notice.

      5. Cover Memorandum (Optional). At its option, the OPDIV may include in the clearance package a cover memorandum to OMB. Circumstances that might occasion a cover memo are special circumstances affecting the information collection request that the OPDIV wishes to draw to OMB's attention (e.g., need for an emergency clearance or discussion of the status of previous conditions of approval). Cover memos should be addressed from the OPDIV through the Department to OMB.

   2. Additional Documentation

      Some clearance requests will require additional documentation as in the examples below.

      1. Renewals. When a clearance package requests renewal of an existing information collection, the OPDIV should include the previous OMB Notice of Action with the renewal package. If OMB placed conditions upon the original approval or placed conditions on the subsequent renewal, the OPDIV should include a copy of those conditions and an explanation of how the OPDIV met those conditions.

      2. Revisions. When a clearance package contains revisions to an information collection previously submitted and/or approved, the OPDIV should provide, in addition to the information required for a renewal, a clear explanation of the revision in the Supporting Statement.

      3. Reinstatements. OPDIVs should manage their paperwork transactions so that information collections whose approval period is nearing expiration do not lapse. However, when OPDIVs wish to reinstate an information collection that has lapsed, the OPDIV should provide an explanation (in a cover note to the HHS Reports Clearance Officer) as to why the collection has lapsed.

   3. Proposed and Final Rules
      1. Proposed Rules. 5 CFR Part 1320.11 requires that, when an information collection is contained in a proposed regulation, the Department must submit to OMB a clearance package for the information collection on or before the day on which the Notice of Proposed Rule Making (NPRM) is published in the Federal Register. Therefore, the OPDIV must submit the information clearance package to the Department before NPRM publication in the Federal Register. The Department will coordinate with the OPDIV so that publication in the Federal Register coincides with OMB receipt of the clearance package.

         The information clearance package must contain a copy of the proposed rule and its preamble. The preamble to the NPRM must include notification that the Department has requested OMB review of the information collection and direct that comments be sent to the OMB reviewer. Publishing this notification in the NPRM satisfies the requirement for public notice.

         Consult OMB's draft Implementing Guidance for information on the OMB review period and potential OMB actions.

      2. Final Rules. If the information collection contained in an NPRM is identical to the one to be included in the final rule, the OPDIV need not resubmit a PRA clearance package during the final stage of rulemaking. If modifications have been made to the information collection between the NPRM and final stages, the OPDIV must resubmit the clearance package for OMB approval. Resubmission must occur on or before the date of publication of the final rule.

         Consult OMB's draft Implementing Guidance for information on the OMB review period and potential OMB actions for final rules.

   4. Emergency Clearances

      OPDIVs may only seek emergency clearances when compelling circumstances arise that could not have been foreseen. Failure to plan ahead is not an adequate reason to declare an emergency. OPDIVs must provide a full explanation of the emergency situation in the Supporting Statement.

      The OMB draft Implementing Guidance cites the following conditions governing emergencies:

      When the collection of information --

      • is needed prior to the expiration of time periods established under 5 CFR 1320; and

      • is essential to the mission of the agency; and

      When the agency cannot reasonably comply with the normal clearance procedures under 5 CFR 1320 because --

      • public harm is reasonably like to result if normal clearance procedures are followed;

      • an unanticipated event has occurred; or

      • the use of normal clearance procedures is reasonably likely to prevent or disrupt the collection of information or is reasonably likely to cause a statutory or court ordered deadline to be missed.

      Consult OMB's draft Implementing Guidance for the process to be followed when requesting an emergency clearance.

   5. Coordination with the Data Council and the Office of the Assistant Secretary for Planning and Evaluation.

      The Data Council, with representation from all the OPDIVs, monitors all health and non-health data collection and analysis activities of the Department, including an integrated health data collection strategy (i.e., the HHS Survey Integration Plan). The Data Council is involved in the planning, development, and review of major national surveys. Major surveys are those surveys that deal with important or controversial policy issues, impact the Department or OPDIVs, and/or involve budget development. The Assistant Secretary for Planning and Evaluation (ASPE) supports the Data Council mission and is also involved with reviewing national surveys. The Department will examine OPDIV PRA submission packages to ensure compliance with standards and best practices (emanating from the Data Council), and for evidence of ASPE involvement in the preparation of national surveys.

2. Informing OPDIVs of OMB and Departmental Actions

   For all clearance packages--ordinary information collections and information collections in proposed or final rules--the Department will notify the OPDIV Clearance Officer by e-mail:

   • when the Department has sent a clearance package to OMB for approval and

   • when OMB has provided the Department with a Notice of Action. The Department will also forward to the OPDIV Clearance Officer an electronic version of the Notice of Action.

3. The OMB Review Process

   The OMB review process for ordinary information collections and information collections contained in proposed or final rules is explained in the OMB draft Implementing Guidance.

   1. OMB and OPDIV Communications

      Informal communications between OPDIVs and OMB frequently result in OPDIVs preparing and sending to OMB additional supporting documents, beyond those included in the original clearance package. These may be modified Supporting Statements, memoranda, e-mail messages, etc. It is important for the OPDIVs to provide the Department with copies of such documents by e-mail or by fax, because the Department's files must be complete and OMB holds the Department responsible for compliance with laws, regulations, and terms of clearance. OPDIV Clearance Officers must see to it that the Department is kept informed of any additional communications between OPDIVs and OMB.

   2. Terms of Clearance

      OPDIVs are responsible for complying with terms of clearance that OMB may impose on their information collections as conditions of approval. It is particularly important that the OPDIV Clearance Officers keep the Department informed of progress in meeting terms of clearance communicated in OMB Notices of Action. Clearance Officers should bear in mind that any actions for renewal of approval would require explanation as to how previous terms of clearance have been met.

4. The Information Collection Budget and Burden Management

   The Paperwork Reduction Act of 1995 requires that the Director of the Office of Management and Budget,

   "In consultation with the agency heads, set an annual government goal for the reduction of information collection burden by at least 10 percent during each of fiscal years 1996 and 1997 and 5 percent during each of fiscal years 1998, 1990, 2000, and 2001, and set annual agency goals to reduce information collection burdens imposed on the public that represent the maximum opportunity in each agency..." (44 U.S.C. 3505(a)(1)).

   "[report annually on] a summary of accomplishments and planned initiatives to reduce collection of information burden." (44 U.S.C. 3514(a)(2)(A)(I)).

   "[report annually on] a list of any increase in the collection of information burden, including the authority for each such collection." (44 U.S.C. 3514(a)(2)(A)(iii)).

   To meet these responsibilities, OMB requires each government agency to prepare an annual Information Collection Budget (ICB). The ICB is an annual accounting of the previous year's accomplishments and the presentation of a plan for burden reduction in the current year. OMB compiles the agencies' reports into a single government-wide total and compares each year with the information collection burden baseline developed in fiscal year 1995.

   Each year, approximately two months after the end of the fiscal year, OMB issues a Bulletin describing the ICB, the types of information required, and the format for reporting that information. The Department notifies the OPDIVs when OMB publishes the ICB Bulletin and provides nstructions for OPDIV ICB submission. The Department will prepare the annual ICB based upon data supplied by the OPDIVs.

   The OPDIVs must develop an information collection burden management plan and maintain records sufficient for developing the annual ICB. At a minimum, the OPDIVs must be able to provide:

   1. The total information collection burden in hours and number of collections for the previous year, and the burden reduction goals for the current year.

   2. The most significant burden reduction accomplishments from the previous year.

   3. The most significant planned burden reduction initiatives for the current year.

   If an OPDIV's total information collection burden will increase for the current year, the OPDIV must provide the primary statutes and/or regulations that cause the increase.

5. The Paperwork Reduction Act and the Government Performance and Results Act

   The Government Performance and Results Act (GPRA) must be fully implemented by October 1, 1998. GPRA requires the OPDIVs to identify data to provide baselines for future performance measurement. GPRA also requires OPDIVs to set performance targets, assess accomplishments, and validate and verify assessments. OPDIV Reports Clearance Officers should be aware of GPRA related activities in their respective OPDIV and provide appropriate assistance and guidance:

   1. in making use of existing data;

   2. evaluating additional data needs;

   3. identifying obsolete information collections; and

   4. identifying need for generic customer satisfaction survey.

6. Generic Clearances/Customer Satisfaction Surveys

   Executive Order 12862, Setting Customer Service Standards, directs Federal agencies to establish standards for providing service to the public. Agencies are directed to survey their customers to "determine the kind and quality of services they want and their level of satisfaction with existing services." All customer satisfaction surveys of non-Federal employees are covered by the PRA and, therefore must go through the full information collection clearance process. The OMB Implementing Guidance describes the process and requirements for developing a generic clearance which can be used for customer satisfaction surveys. OMB describes the generic clearance as having two review stages:

   1. a full review of the overall master data collection plan; and

   2. a quick review of the actual details of each task within the plan.

   OMB especially emphasizes the planning aspect of creating a generic clearance. The master data collection plan "must provide enough detail to provide the public with a basis for comment on a par with a normal single-task clearance" and "must be managed so that there are no surprises or controversies that bypass the public comment period."" The more detail provided, the more likely OMB will approve the generic collection. Once approval is granted OMB will review the individual surveys in an expedited manner.

   OPDIVs wishing to conduct customer satisfaction surveys may consider seeking approval for a generic clearance. When submitting a request for a generic customer satisfaction clearance, OPDIVs must prepare a supporting statement that meets all the standard PRA requirements. In addition, the supporting statement should:

   1. describe the nature of the survey;

   2. describe the anticipated number and frequency of the customer surveys;

   3. describe the customers, clients or partners to be surveyed;

   4. provide examples of the types of questions to be asked; and

   5. describe the statistical methodology to be used to analyze the survey responses.

   When OMB approval is granted, the OPDIV will send a copy of the survey instrument and a cover memorandum to OMB through the Department referencing the OMB approval and describing the contents and intent of the survey. The Department will review the submission and forward it to OMB for its review. All surveys conducted under a generic clearance must reflect the OMB approval number and expiration date.

7. Race and Ethnicity in HHS Data Collection Activities

   On October 24, 1997, the Secretary issued a directive titled, "HHS Policy for Improving Race and Ethnicity Data - ACTION." The policy requires the inclusion of information on race and ethnicity in all HHS-sponsored data collections systems, with certain exceptions. The policy also requires that the minimum standards specified by the Office of Management and Budget for race and ethnicity data and reporting be used, including any subsequent revisions to the OMB standards. We have included at the Department's web site the Secretary's memorandum and "Policy Statement," along with an electronic link to OMB Bulletin 00-02.