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2. 2 BACKGROUND OMB was originally granted authority to approve federally sponsored data collections 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 of 1980 (reissued 1995) Purpose: to ensure that Federal agencies do not overburden the public with federally sponsored data collections

3. 3 44 U.S.C. chapter 35 PAPERWORK REDUCTION ACT Agency’s collection of information should: Minimize burden on respondents and cost of the collection to the agency Serve an agency purpose in meeting a specific agency need Maximize practical utility Not unnecessarily duplicate available information

4. 4 PAPERWORK REDUCTION ACT (cont.) Collection of information: obtaining statements of facts or opinions, regardless of form or format, for answers to identical questions posed to 10 or more persons.

5. 5 PAPERWORK REDUCTION ACT (cont.) Directs OMB to develop and oversee the implementation of Government-wide policies, principles, standards, and guidelines concerning statistical collection procedures and methods.

6. 6 The Federal Government A Federal agency is considered to “conduct or sponsor” a collection of information if the agency Collects the information Causes another agency to collect the information Contracts with a person to collect the information, or Requires a person to provide information to another person

7. 7 INVESTIGATOR-INITIATED GRANTS A collection of information undertaken by a recipient of a Federal grant is considered to be “conducted or sponsored'' by an agency only if: The recipient of a grant is conducting the collection of information at the specific request of the agency; or (2) The terms and conditions of the grant require specific approval by the agency of the collection of information or collection procedures.

8. 8 Exempt from PRA/OMB clearance Federal employees Individuals under treatment or clinical examination in connection with research on or prophylaxis to prevent a clinical disorder, direct treatment of that disorder . . . (clinical exemption)

9. 9 INFORMATION COLLECTION Statement of fact or opinion SURVEYS INTERVIEWS QUESTIONNAIRES FOCUS GROUPS FORMS REPORTING RECORDKEEPING DISCLOSURE

10. 10 INFORMATION COLLECTION (cont.) HARD COPY (PAPER) TELEPHONE ELECTRONIC – COMPUTERIZED WEB BASED DIGITIZED TAPE, DISK AUTOMATED PHONE RESPONSES iPOD, BLACKBERRY, PDA TEXT MESSAGING,TELEMETRY FACE TO FACE

11. 11 Paperwork Reduction Act Applies everywhere United States Globally

12. 12 What is PRA/OMB Clearance? PRA/OMB Clearance is the process which requires all Federal agencies to have in place a system to ensure that any collection of information from more than nine individuals meets OMB standards and is submitted to OMB for approval.

13. 13 PRA/OMB Process 60-day Federal Register Notice ICR package Supporting Statement Attachments (e.g., questionnaires, surveys) 30-day Federal Register Notice; forward submission to PCB prior to forwarding through DHHS DHHS reviews and forwards to OMB for review and approval

14. 14 60-DAY FEDERAL REGISTER NOTICE Each agency must publish a 60-day notice in the Federal Register to obtain public comment on the collection prior to submitting the information collection to OMB. Agencies may also have requirements for internal review or higher level reviews that need to be factored into the schedule for planning a survey.

15. 15 60-DAY FEDERAL REGISTER NOTICE (cont.) To solicit public comment: Evaluate whether proposed collection is necessary, including practical utility Evaluate accuracy of burden estimate Enhance the quality, utility, and clarity of the information to be collected Minimize the burden of the collection of information on those who are to respond

16. 16 BURDEN Total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency

17. 17 CHECKLIST FOR SUBMISSION Supporting Statement A and B Worksheets Part I and II Data Collection Instruments Introductory and follow-up letter to respondents, including consent forms IRB approval Other relevant documentation

18. 18 Flowchart for PRA/OMB Clearance Process

19. 19 GENERIC CLEARANCE A plan for conducting more than one collection of information using very similar methods. Considered only when the agency is able to demonstrate that there is a need for multiple, similar collections, but the specifics of each collection cannot be determined until shortly before the data are to be collected.

20. 20 GENERIC CLEARANCE Review occurs in 2 stages: Full OMB review of the generic clearance ICR Expedited review of the individual collections that fall within the scope of the generic clearance.

21. 21 GENERIC CLEARANCE Expedited Review Documents required: Cover memo or mini-supporting statement Generic clearance form Survey instrument

22. 22 GENERIC CLEARANCE Expedited Review (cont.) Burden hours – IC must track burden hours Number of hours approved in main ICR Which survey used how many hours If more than 1 survey, number as follows: 0925-xxxx-1, 0925-xxxx-2, etc.

23. 23 GENERIC CLEARANCE Timeline

24. 24 GENERIC CLEARANCE The only projects OMB approves for generic clearance are: Simple customer satisfaction surveys where the results will be used for internal NIH purposes only, and Studies concerning formative research

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26. 26 Generic NIH ICRsas of 11/14/08

27. 27 Related Links Project Clearance Branch http://odoerdb2.od.nih.gov/oer/policies/project_clearance/pcb.htm FAQs about PRA http://www.hhs.gov/ocio/policy/collection/infocollectfaq.html Office of Communications and Public Liaison http://www.nih.gov/icd/od/ocpl/resources/OMBClearance/ OMB Guidance on Agency Survey and Statistical Information Collections http://www.whitehouse.gov/omb/inforeg/pmc_survey_guidance_2006.pdf

28. 28 KEY POINTS Information collection must be necessary to the proper function of the agency Agency must specify how the information will be used Burden must be minimized as much as possible OMB approval process takes about 6-9 months

29. 29 Questions?