# Presentation: 001018

## Policies and Procedures

**PAPERWORK REDUCTION ACT AND PRA/OMB CLEARANCE**
**Policies and Procedures**

**Marilyn Tuttleman, M.S.**
**Project Clearance Officer**
**(301) 594-7949**
**mt25d@nih.gov**

**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**

**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**

**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.**

**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.**

**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**

**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. **

**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)**

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

**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**
**	****	****	**

-                 **Paperwork Reduction Act **
**Applies everywhere**
**United States**
**Globally**

**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. **

**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**

**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.**

**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**

**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**

**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**

## Flowchart for PRA/OMB Clearance Process

## 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.**

## 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.**

## GENERIC CLEARANCE

**Expedited Review**
**Documents required:**
**Cover memo or mini-supporting statement**
**Generic clearance form**
**Survey instrument**

## 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.**

## GENERIC CLEARANCE

-                                  Timeline

- Package created by PI.
- Includes: cover memo or
- mini-supporting statement,
- generic clearance form,
- survey instrument

- PI sends package to PCB for review

- PCB reviews within
- 1 week

- PCB submits to ICRAS

- HHS reviews in 7-10 days

- OMB reviews in ~1 month

- OMB responds to PCB
- with approval

## 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**** **

## Active NIH ICRsas of 10/7/08

| IC | # ICR |
| --- | --- |
| CC | 2 |
| CSR | 1 |
| FIC | 2 |
| NCCAM | 2 |
| NCI | 17 |
| NCRR | 1 |
| NHLBI | 8 |
| NIAAA | 1 |
| NICHD | 6 |
| NIDA | 4 |
| NIDDK | 4 |
| NIEHS | 5 |
| NIGMS | 1 |
| NINDS | 2 |
| NLM | 2 |
| OD | 13 |
| TOTAL | 71 |

- Source:  ICRAS

## Generic NIH ICRsas of 11/14/08

- *Not included in active ICR list
- Source:  ICRAS

| IC | # ICR |
| --- | --- |
| CC | 1 |
| CSR | 1 |
| FIC | 0 |
| NCCAM | 1 |
| NCI | 3 |
| NCRR | 0 |
| NHLBI | 0 |
| NIAID | 1* |
| NICHD | 2 |
| NIDA | 0 |
| NIDDK | 0 |
| NIEHS | 0 |
| NIGMS | 0 |
| NINDS | 0 |
| NLM | 1 |
| OD | 3 |
| TOTAL | 13 |

- *Not included in Active list

- Source:  ICRAS

**Related Links**
**Project Clearance Branch** _[http://odoerdb2.od.nih.gov/oer/policies/project_clearance/pcb.htm](http://odoerdb2.od.nih.gov/oer/policies/project_clearance/pcb.htm)_
**FAQs about PRA**
- _[http://www.hhs.gov/ocio/policy/collection/infocollectfaq.html](http://www.hhs.gov/ocio/policy/collection/infocollectfaq.html)_
- _[http://www.nih.gov/icd/od/ocpl/resources/OMBClearance/](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](http://www.whitehouse.gov/omb/inforeg/pmc_survey_guidance_2006.pdf)_

**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**

- Questions?