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SMG 3270.1

FDA STAFF MANUAL GUIDES, VOLUME III - GENERAL ADMINISTRATION

INFORMATION RESOURCES MANAGEMENT

PAPERWORK REDUCTION ACT/OMB CLEARANCE

OBTAINING CLEARANCE UNDER THE PAPERWORK REDUCTION ACT OF 1995

Effective Date: 12/14/2011

[PDF Version]

  1. Purpose
  2. Reference
  3. Policy
  4. Definitions
  5. Examples
  6. Responsibilities
  7. Process and Procedures
  8. Effective Date
  9. History

1. PURPOSE

This guide identifies policies, procedures and responsibilities for the Food and Drug Administration (FDA) as required by the Paperwork Reduction Act of 1995 (the Act), OMB, HHS and FDA when seeking OMB approval for collecting information from the public.

2. REFERENCE

The Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) establishes and defines policies and procedures for controlling paperwork burden imposed by Federal agencies on the public. The regulations located at 5 Code of Federal Regulations (CFR) Part 1320, “Controlling Paperwork Burdens on the Public; Regulatory Changes Reflecting Recodification of the Paperwork Reduction Act,” implement the information collection review and approval provisions as prescribed by the Act—its purpose being, “. . . to reduce, minimize and control burdens and maximize the practical utility and public benefit of the information created, collected, disclosed, maintained, used, shared and disseminated by or for the Federal government.” (5 CFR 1320.1). In addition, the Act requires all agencies to obtain the approval of the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget (OMB) before requesting certain types of information.

3. POLICY

OMB designated authority to OpDiv CIOs to oversee the PRA activities of the agency. FDA’s PRA staff is located in the Management Branch of the Division of CIO Support under the Office of Information Management.

All requests for OMB approval of information collections must adhere to and follow clearance procedures set forth in the Act, OMB’s regulations implementing the PRA, as well as guidance provided by FDA’s PRA staff, Office of the Chief Counsel (OCC), Office of Policy (OP), HHS and OMB.

1. The Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520)

2. Controlling Paperwork Burdens on the Public; Regulatory Changes Reflecting Recodification of the Paperwork Reduction Act (5 CFR 1320)

3. Standard Operating Procedures: Paperwork Reduction Act Statements for Guidances (http://inside.fda.gov:9003/it/PaperworkReductionAct/GeneralInformation/ucm019962.htm)

4. DEFINITIONS

(Some of these definitions may be found at 5 CFR 1320.3)

A. Information collection. When the agency obtains, causes to be obtained or solicits information by means of identical questions posed or identical requirements including:

1. Reporting

2. Recordkeeping

3. Disclosure to the Federal government or a third party

Information may be required (mandated by statute or regulation) voluntary, or required to obtain or retain a benefit. Further, information is defined in 5 CFR 1320 as “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” (5 CFR 1320.3(h)).

Information is NOT, “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” (5 CFR 1320.3(h)(1)).

B. Exemptions. The PRA exempts certain collections of information from OMB review and approval (5 CFR 1320.4).

The most common exceptions are:

1. Information or wording that is completely supplied by the Federal government. OMB approval is not required for information that is “originally supplied by the Federal government to the recipient for the purpose of disclosure to the public . . .” An example of this is the Surgeon General’s warning on cigarettes.

2. During the conduct of a Federal criminal investigation or prosecution.

3. During the conduct of a civil action to which the United States or any official or agency is a party, or during the conduct of an administrative action, investigation, or audit, involving an Agency against specific individuals or entities.

C. Burden. A measurement of the total time (time burden), effort, and financial resources (cost burden) expended by persons to comply with the requirement or request. This includes understanding the request, formulating and completing the response, and transmitting or disclosing the information to a federal agency or to a third party (5 CFR 1320.3(b)(1)).

Time burden is measured in minutes or hours. Estimates of burden hours must include estimates of the number of respondents, the frequency or response, and the total number of burden hours per year. Cost burden is measured in U.S. currency. An example of a cost burden would be, for instance, the salary a company would pay an employee to respond to an FDA request or requirement.

Exception to counting burden: Activities incurred in the normal course of doing business, e.g., compiling and maintaining business records, if the agency can demonstrate that the reporting, recordkeeping, or disclosure activities needed to comply are “usual and customary.” This type of information collection still requires OMB approval but there is no burden estimated for this activity (5 CFR 1320.3(b)(2)).

OMB requires that burden be separated and counted in three different categories:

1. Reporting: submitting information to FDA

2. Recordkeeping: maintaining or keeping specified records, including notifying the agency, the public or a third party that the record exists

3. Third party or public disclosure: a requirement for a person to obtain, compile, or locate information for the purpose of making it known to others, including members of the general public at large and personswith which the respondent does business (supply chain reporting), through posting, notification, or labeling (i.e. nutrition labeling for food)

D. Person (or respondent). Individuals, households, businesses in the private sector, corporations, or State, local or Tribal governments (5 CFR 1320.3(k)). OMB approval is generally required for an information collection imposed on 10 or more persons—the people to whom the requirement or request is directed.

E. Ten (10) or More Respondents. The number of respondents to which an information collection requirement or request is directed within a 12-month period. Ten respondents triggers the need for OMB approval for an information collection. Be sure to:

1. Count people, businesses, or governments to whom the collection is directed

2. Do not count employees or contractors who work for respondents

3. Do not count Federal agencies, current employees or active duty military except to count Federal entities for general purpose statistics (see 5 CFR 1320.3(c) (3)).

F. Practical Utility means the actual, not merely the theoretical or potential, usefulness of information, to or for an agency, taking into account its accuracy, validity, adequacy, and reliability. Included, as well, is assuring proper and practical use of the information.

G. Capital costs are one time costs of investments (example: purchasing new computers and software or a new type of label, designing a new data system, building record storage facilities.) These are not considered “cost burden” (See item B for cost burden).

H. Operating and maintenance costs are recurring costs (example: operating and maintaining capital investments, redesigning existing labels, postage and copying costs.) These costs are not considered “cost burden” (See item B for cost burden).

I. A 60-day notice is published in the Federal Register and solicits public comment for 60 days on these four elements (5 CFR 1320.8(d)(1):

1. whether the information collection is necessary for the proper performance of the functions of the agency, including whether the information is useful (practical utility);

2. whether the agency’s burden estimate is accurate, including whether the agency used valid methods and assumptions;

3. whether there are any ways to enhance the quality, utility, and clarity of the information the agency plans to collect; and

4. to what extent the agency has minimized the burden on the public, including whether the agency should expand the electronic reporting options for respondents.

J. A 30-day notice is published in the Federal Register and solicits public comment on the information collection for 30 days and informs the public that the information collection request has been submitted to OMB for review and approval. Comments on the FR notice go to OMB. The 30-day notice should publish within one year after the 60-day notice publishes (5 CFR 1320.10(a)).

K. Supporting Statement. This is the key document in the Innformation Collection Request (ICR) that justifies and describes the purpose, scope, and benefits of the information collection. OMB reviews it to determine whether or not to approve the information collection.

L. Information Collection Request (ICR). A collection of documents submitted to OMB that explains and supports the need for the information. The ICR includes the supporting statement drafted using the current template provided by the PRA staff and documents associated with the information collection, e.g., proposed or final rule, guidance, survey or form. The ICR should be received at OMB no later than 10 days after the rule or 30-day notice publishes.

M. Program Changes: Initiating a new information collection, terminating or making changes to burden, respondents or the way the information is collected in existing information collections. Program changes are the result of action by FDA (even if the action is the result of Congressional direction). Some examples of program changes to existing information collections may be:

1. adding, omitting, or changing questions;

2. changing the frequency of an reporting, recordkeeping or disclosure; and

3. requiring a different group of respondents to respond or comply with a request or requirement.

N. Adjustments: Changes to burden that are the result of factors outside FDA’s control. Some examples of adjustments are:

1. correcting errors in the burden estimate; and

2. increasing or decreasing burden hours due to factors outside the agency's direct control, such as population changes, a change in the number of firms in an industry; or because a different number of respondents decide to respond or to use the data collection instrument.

O. Violation or “bootleg”. When a Federal agency collects from the public, information covered by the PRA but without OMB approval. Without a valid OMB approval, FDA cannot legally collect the information, regardless if it is mandated. The public can refuse to respond to the information collection requirement or request if there is no valid OMB approval. Violations are reported in the annual Information Collection Budget (see item P) report to Congress. A violation can occur with a new collection of information that does not have OMB approval or when an already approved ICR expires or when a statute requires a report to be filed with FDA but FDA did not seek OMB approval.

P. Information Collection Budget. An annual data call report that is required by OMB. All OpDivs are asked to confirm changes in burden hours and costs for the previous fiscal year as provided by OMB, and any new information collections for the upcoming fiscal year. Because FDA’s burden hours exceed 10 million, we are charged with reducing our overall burden by 1% of the current burden. HHS consolidates the individual OpDivs’ information and sends a final report to OMB. OMB prepares and sends to Congress a final report on behalf of the entire Federal government (5 CFR 1320.17).

Q. Public Protection Provision. “An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.” This statement must appear on all FDA forms as well as FR notices announcing OMB approval (5 CFR 1320.6).

R. OC/RPMS or RES (Regulations Policy and Management Staff/Regulations Editorial Staff). This staff edits and prepares notices and rules for publishing in the FR (http://inside.fda.gov/ProgramsInitiatives/CommitteesWorkgroups/RegulationsPolicyStaff/index.htm).

S. FRDTS (Federal Register Document Tracking System) is part of AIMS (Agency Information Management System). All documents to be published in the FR are logged into this system before being submitted to RPMS. This tracking system requires account set up.

T. FDMS (Federal Document Management System). Comments on FDA’s 60-day FR notices are sent by the public or industry through FDMS.

U. ICRAS (Information Collection Request, Review, and Approval System). The tracking system, through which, FDA submits ICRs to HHS (http://paperworkreduction.gov/about.html).

V. ROCIS (Regulatory Information Service Center (RISC) and Office of Information and Regulatory Affairs (OIRA) Combined Information System). The tracking, system through, which HHS submits FDA’s ICRs to OMB.

W. OMB control number. An 8-digit number assigned by OMB for each FDA approved information collection. The first four numbers, 0910, are FDA specific; the last 4 are sequentially assigned by OMB.

X. Regulations.gov. The website, through which, the public may submit comments to rules.

5. EXAMPLES

A. Types of Activities That Constitute Burden. Some common FDA collections of information may include (burden classification follows in parentheses):

1. sending an annual report (also includes the time to search data files for the information) (reporting);

2. keeping records of testing results (recordkeeping);

3. labeling (third party disclosure);

4. submitting applications, i.e. a New Drug Application (reporting);

5. registration and listing of a new company beyond simple identification (reporting);

6. automated, electronic, mechanical or other technological collection techniques or combinations of data collection methods, i.e., company or manufacturer registration and listing using the FDA Gateway (reporting);

7. giving answers to a survey or in a focus group discussion (reporting);

8. completing a form (includes reading the instructions) (reporting);

9. developing, acquiring, installing and utilizing technology and systems for processing, maintaining, disclosing, collecting, providing, validating, and verifying information (reporting);

10. training personnel to be able to respond to a collection of information (often included in the reporting burden for another activity such as preparing a report);

11. completing and reviewing the collection of information (often included in the reporting burden for another activity such as completing a form);

12. developing and maintaining company standard operating procedures (reporting and possible recordkeeping); and

13. performing a specific test in order to generate a specific report or record (reporting and recordkeeping).

B. Method of Collection. The method by or through which, regardless of form or format, an agency conducts or sponsors a collection of information does not alter the requirement that the agency obtain OMB approval. Some methods of collection are:

1. on paper or fillable PDF;

2. orally, in person or by telephone;

3. electronically, including data standards, and instructions for Electronic Data Exchange, Internet-based forms or “wizards,” E-mail; and

4. any other approach through which the respondent or potential respondent is able to provide the response, recordkeeping, or disclose the information.

FDA must offer respondents an electronic means of reporting to be compliant with the Government Paperwork Elimination Act.

C. Collection Instruments. Some examples of various ways and documents by which the agency may solicit information are:

1. rules and regulations;

2. focus groups;

3. qualitative or quantitative surveys;

4. guidance documents; and

5. grants, contracts, cooperative agreements, and memorandums of need.

D. Reporting. Some examples of reporting are:

1. completing an FDA form;

2. completing a survey;

3. participating in a focus group;

4. apply to be on a list of exporters of an FDA-regulated product;

5. completing a New Drug Application; and

6. applying for an Investigational Device.

E. Recordkeeping Requirements. Some examples of recordkeeping requirements are:

1. creating and retaining records;

2. notify, disclose and report the existence of the record to a third party, the Federal Government, or the public; and

3. creating and maintaining standard operating procedures.

F. Disclosure to Third Parties or the Public. Some examples include:

1. labeling; and

2. providing a report to a party other than the Federal government.

6. RESPONSIBILITIES

The PRA designates the Chief Information Officer (CIO) of FDA responsibility for the implementation and management of FDA’s paperwork control functions.

A. Office of Information Management (OIM)

1. Reports Clearance Officer (RCO). The CIO has designated the Team Leader of the Paperwork Reduction Act team as FDA’s Reports Clearance Officer. The RCO is responsible for ensuring that the proper procedures are followed when requesting OMB approval for collections of information and must certify that the proposed collections of information meet applicable requirements.

2. The PRA team consists of PRA specialists who work directly with center program experts, HHS and OMB. These PRA specialists are the Agency's liaison between FDA, HHS, and OMB.

OIM is responsible for the following:

a. maintaining records and inventories of the Agency's information collection activities;

b. reviewing and providing technical support and guidance to centers and program experts on PRA issues, as well as assuring that all proposed rules and regulations meet standards for approval by OMB;

c. reviewing and/or preparing the following Federal Register notices for publication:

i. 60-day notices to request comments on proposed collections of information;

ii. 30-day notices to request comments and announce that a collection of information is being submitted to OMB for review;

iii. notices of approval to announce that OMB has approved a collection of information;

d. providing PRA training to agency personnel; and

e. facilitating communication between FDA centers, HHS and OMB, including negotiating special procedures for unique circumstances.

B. Centers/Offices

1. Assistant Reports Clearance Officers (ARCO). Each Center/Office has designated an ARCO and an alternate to carry out the PRA control functions for their Center/Office. They are the liaison between their various program offices and OIM. Their duties include receiving and reviewing collection of information requests, and tracking the progress of their requests.

2. Program Offices. In addition to preparing the required ICR, program offices must have their statistical and consumer surveys reviewed for methodology and survey design. The program office must provide evidence of this review to the Reports Clearance Officers in OIM for inclusion in the agency’s request for OMB review.

Centers and program offices are responsible for the following:

a. maintaining records and inventories of their center’s PRA clearance activities;

b. acting as a liaison between PRA specialists and Center program experts;

c. assisting program experts in understanding requirements of PRA and identifying such in rules and guidance documents;

d. assuring that 60-day notices are drafted using the current template and are complete prior to sending to PRA specialist;

e. assuring that final ICRs are accurate and complete prior to sending to PRA specialist;

f. reviewing and providing technical support and guidance to Agency program organizations on PRA issues, as well as assuring that all proposed rules and regulations meet standards for approval by OMB; and

g. assisting in the preparation of their centers PRA activities for the ICB.

C. Office of Chief Counsel (OCC). OCC may advise center and program experts on the legal implications of the PRA. OCC may review notices and responses to comments if requested by the center or if the comments are considered to be controversial.

D. Regulations Policy and Management Staff (RPMS) and Regulations Editorial Staff (RES). The RPMS desk officers and RES editors review and assure that all Federal Register documents relating to PRA meet the Office of the Federal Register standards for publication.

7. PROCESS AND PROCEDURES

A. Identifying information collection, drafting the PRA analysis, and preparing and submitting the ICR to OMB for review and approval

1. Identify information collection. You may have an information collection that requires OMB approval if you find these words in your document: record, notify, keep, maintain, submit, retain, report, obtain, provide, disclose, register, label, establish and follow written procedures. Consult with your PRA specialist if necessary.

2. Draft the PRA analysis (including estimating the annual burden) for publication in the Federal Register. Once the information collection activities are identified you can begin estimating hourly and cost burden for each activity. You may use past experience or consult with a small number of respondents (3-5) to find out how much time, effort and cost is associated with responding to the information collection. The basis for your estimate should be included in narrative form in the analysis. (Use current boilerplate language and templates available on the RES website. Draft the supporting statement according to the current template and instructions and e-mail it to your PRA specialist for review)

3. Prepare the ICR in ICRAS. Your PRA analyst will prepare and submit the ICR via ICRAS.

B. New Collection of Information that is not a Regulation. (These may include but are not limited to surveys, guidance documents, pilot programs and new forms.) The entire process may take up to nine months to complete. This time period includes:

1. Center’s Responsibilities

a. Work with PRA Specialist to identify information collection

b. Send the draft NOA (that contains the 60-day notice in a separate PRA section) to the specialist

c. Send the NOA to OC/RPS for publication

d. Prepare a response to information collection related comments received to the NOA (These comments are included in the 30-day notice and the supporting statement)

e. Draft the supporting statement and send it to the specialist

2. PRA Specialist’s Responsibilities

a. Review and approve the PRA section in the NOA

b. Sign the blue sheet clearance record

c. Draft the 30-day notice and include the center’s response to the comments. Send it to OC/RPS

d. Review the supporting statement and develop the ICR in ICRAS

e. Notify HHS of notice publication date and request the ICR to be submitted to OMB

f. Coordinate discussions with OMB

OMB may take action 30 days after the ICR is received.

C. Notice of Proposed Rulemaking (NPRM) and Final Rules.

1. Center’s Responsibilities

a. Work with PRA specialist to identify information collection that requires OMB approval.

b. Once the codified language is close to final, and you have drafted the PRA section, you may submit your rule to the specialist. (Simultaneous PRA and OCC review may expedite the process.)

c. Draft the PRA analysis for inclusion in the PRA section of the rule.

d. Prepare a response to information collection related comments received to the NPRM. (Public comments are sent to OMB. FDA’s response is included in the final rule and the supporting statement.)

e. Draft the supporting statement and send it to the specialist at least one to two months before the rule publishes.

2. PRA Specialist’s Responsibilities

a. Provide guidance to center to determine what information collection requires OMB approval

b. Review and approve the PRA section

c. Sign the blue sheet clearance record

d. Review the supporting statement

e. Develop the ICR in ICRAS

f. Coordinate discussions with OMB

g. Notify HHS of the rule’s publication date and request the ICR be submitted to OMB

D. Direct Final Rules Containing a Collection of Information

1. Option 1: A new information collection associated with a direct final rule needs to be approved on an emergency basis because there was never an NPRM published offering the public an opportunity to comment. The emergency request for approval would be published in the FR first. Publication of the DFR/NPRM would follow after OMB approval was granted for the emergency. (The reason for taking this approach would need to meet the emergency approval criteria.) (See emergency clearance procedures on page 29)

2. Option 2: If there is not a valid justification for emergency approval then the information collection should not be in the direct final rule. FDA would need to propose and collect comments through the companion NPRM (both the DFR and NPRM published on the same day). This approach is allowed only if the ICR related issues are discrete and separable from the rest of the rule. If the entire rule is related to information collection (e.g., a recordkeeping or reporting rule) then FDA would need to proceed with the first option or just do an NPRM (i.e., no direct final rule at all).

E. Emergency Requests

1. Notify the PRA specialist at the time of the project’s concept.

2. There are three situations where OMB might consider granting an emergency approval:

a. public harm is reasonably likely to result if normal clearance procedures are followed;

b. an unanticipated event has occurred (with public health consequences); and

c. a normal clearance is likely to cause a statutory or court-ordered deadline to be missed.

3. OMB grants emergency approval for six months only. The renewal process to extend OMB approval for a further three years must begin once the approval is granted.

4. A “background information sheet” must be prepared including the reason for the emergency, consequences if an emergency approval is not granted, a description of the information being collected, and the target audience.

5. Center’s Responsibilities

a. Prepare and send the PRA specialist a background information sheet to be sent to OMB.

b. Draft the FR notice soliciting public comment and send it to the specialist. (OMB may decide to waive the comment period.)

c. Prepare a response to information collection related comments received to FR notice. This is included in the supporting statement.

d. Draft the supporting statement and send it to the specialist.

6. PRA Specialist’s Responsibilities

a. Prepare and send the specialist a background information sheet to be sent to OMB.

b. Draft the FR notice soliciting public comment and send it to the specialist. (OMB may decide to waive the comment period.)

c. Prepare a response to information collection related comments received to FR notice. This is included in the supporting statement.

d. Draft the supporting statement and send it to the specialist.

8. EFFECTIVE DATE

December 14, 2011

9. Document History -- SMG 3270.1, Obtaining Clearance under the Paperwork Reduction Act of 1995

STATUS (I, R, C) DATE APPROVED LOCATION
OF CHANGE HISTORY
CONTACT APPROVING OFFICIAL
Initial 06/2005 N/a PRA and Records Management Branch (HFA-250) Mark Pincus, PRARMB Chief
Revision 12/14/2011 N/a OIM/DCIOS/MB  Elizabeth Berbakos, MB Chief