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SMG 3295.1

FDA STAFF MANUAL GUIDES, VOLUME III - GENERAL ADMINISTRATION

INFORMATION RESOURCES MANAGEMENT

FORMS MANAGEMENT

FDA FORMS MANAGEMENT

Effective Date: 06/12/2007
Changed: 03/10/2011

[PDF Version]

 1. Purpose
 2. Policy
 3. References
 4. Definitions
 5. Responsibilities
 6. Determining Need and Requirements for New/Revised Forms
 7. Printed Forms
 8. Electronic Forms
 9. Periodic Review of Forms
 10. Deletion of Obsolete Forms
 11. Forms Management in Field Activities
 12. Effective Date
 13. Document History

1. PURPOSE 

This Guide outlines the FDA Forms Management Program and establishes Agency policy and procedures for developing and/or ordering new, revised, and reprinted forms. It supplements, and is to be used in conjunction with, the Department of Health and Human Services (HHS) Forms Management Manual.

2. POLICY 

The FDA will use the uniform system prescribed in this Guide for creating, publishing and managing forms.

A. The FDA Forms Management Program will:

1. ensure the forms created within the Agency are current and able to collect the information that is needed;

2. provide effective control, uniform procedures and standards across the Agency for the creation, production and use of both public and internal forms;

3. promote effective systems by providing essential forms that are developed and designed for maximum efficiency in handling and processing data, for example, by making one simple form with well thought out fields that collect the maximum amount of information without an excessive amount of input or effort on the part of the user;

4. eliminate unnecessary and duplicate forms across Center/Office lines and across Department lines and consolidate those serving like or similar functions;

5. facilitate the design and use of public-use and internal electronic forms that comply with the Government Paperwork Elimination Act;

6. reduce the cost of forms by using the most economical methods of printing and distribution consistent with Government Printing Office use requirements and restrictions on printing by Federal Agencies found in SMG h:2205.1 , and promote the use of electronic forms to avoid printing, storage, and shipping costs; and

7. manage Agency use of higher authority or organizational forms, i.e., Standard Forms (SF), Optional Forms (OF), or Department Forms (HHS) http://intranet.hhs.gov/forms/.

B. The FDA Forms Management Officer (FMO) will use workflow analysis, graphic design techniques and standardization to create or revise forms in order that:

1. forms are easy to complete and the instructions are clear;

2. the layout of the form is well planned, allows adequate space, and limits errors;

3. productivity is increased in preparation, use, filing and retrieval;

4. errors are minimized in information capture, transmission and recovery;

5. the total number of forms within the system is minimized;

6. data element relationships are apparent through consistency and adherence to standards;

7. the effectiveness of the entire system, as well as the individual form, is enhanced;

8. procurement, storage, and distribution and use costs are reduced; and

9. the resulting business tool accomplishes its intended purpose.

3. REFERENCES 

A. HHS Forms Management Manual

B. The General Services Administration (GSA) Information Resources Management Technical Guide - Electronic Forms Systems Analysis and Design. Order or download for a fee from National Technical Information Service at (800) 553-6847. Order Number PB95250239.

C. Privacy Act, 1974, http://www.access.gpo.gov/nara/cfr/waisidx_04/21cfr21_04.html

D. Staff Manual Guide h:2205.1, "Printing Procurement (Headquarters)"

E. Staff Manual Guide 2250.3, "Contractor Supplemental Mailings"

F. Staff Manual Guide 2250.4, "Selection of U.S. Postal Service Mail Classes and Services"

G. Staff Manual Guide 2250.5, "Format For Printing FDA Return Address" (formerly 2420.11)

H. Government Paperwork Elimination Act "Procedures and guidance." http://www.whitehouse.gov/omb/fedreg/gpea2.html#m00-10attach

I. Section 508 http://www.section508.gov/

J. Staff Manual Guide 3130.3, "Electronic and Information Technology Accessibility for Individuals with Disabilities Under Section 508 of the Rehabilitation Act Amendments of 1998"

K. Plain Language in Government Writing Initiative, http://www.fda.gov/ohrms/dockets/dockets/91n0384h/91n-0384h-bkg0003-Tab-14-vol19.pdf

4. DEFINITIONS 

A. Form - The basic business tool (whether printed or electronic) for collecting and transmitting information. The catalyst for getting things done. The record of what was done.

B. FDA Forms - The prefix, FDA, identifies the Agency forms for both Headquarters and Field activities. These forms are assigned sequential numbers, which are used as specific identification and as a means of stocking, ordering, and general control.

C. Electronic Forms - Forms that are designed to streamline existing business processes with current computer technology. Electronic forms are required to be Section 508 compliant. There are different types of electronic forms that vary in complexity:

1. Printable - completed by hand and submitted via mail or fax.

2. Fillable - completed online (using the computer) and then emailed; or printed and submitted via mail or fax.

3. Database - completed through use of database information and then emailed; or printed and submitted via mail or fax.

4. Electronic submission - completed online (or from database) and submitted electronically (via Internet, for example or emailed).

5. Digital signature - completed online or from database and submitted electronically with an electronic signature to ensure the integrity of the information used to create an electronic record.

5. RESPONSIBILITIES 

A. FDA Forms Management Officer, Office of the Chief Information Officer, Paperwork Reduction and Records Management Staff.

1. Reviews and approves/disapproves all FDA forms requests.

2. Provides overall direction, guidance, and technical assistance to the Forms Management Program throughout the FDA and carries out responsibilities as assigned in the HHS Forms Management Manual.

3. Consults with management officials and assists in the development of forms in support of specific programs, and coordinates with related management programs (i.e., reports, records, and directives).

4. Initiates periodic review of forms for current need, possible improvements or consolidation while ensuring that information necessary for all the interested Centers/Offices is included in any consolidated form. FMO also ensures that electronic forms are 508 compliant.

5. Issues the FDA forms web pages on both the Internet (public forms) http://www.fda.gov/opacom/morechoices/fdaforms/fdaforms.html and Intranet (all FDA forms) http://inside.fda.gov/Administrative/Forms/FDA/index.htm.

6. Complies with the requirements of the Privacy Act of 1974 http://www.access.gpo.gov/nara/cfr/waisidx_04/21cfr21_04.html; Section 508 http://www.section508.gov/; Plain Language in Government Writing initiative http://www.fda.gov/ohrms/dockets/dockets/91n0384h/91n-0384h-bkg0003-Tab-14-vol19.pdf; and the Paperwork Reduction Act of 1995 http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=104_cong_public_laws&docid=f:publ13.104.pdf

7. Maintains record copies of all Agency forms as well as documentation of forms histories.

8. Approves, enters and edits forms records of FDA public use forms included on the Forms.gov web site which is the US Governments official hub for federal forms and part of the President’s Management Agenda.

B. Printing Management Officer, Office of Acquisitions and Grants Services (OAGS); SMG h: 2205.1, "Printing Procurement (Headquarters)".

1. Provides technical direction for the conduct of a coordinated program controlling the development of materials to be printed or duplicated.

2. Assures the procurement and production of printed matter for FDA Headquarters activities through the Program Support Center (PSC), Publication Technologies Branch, the Government Printing Office (GPO), other Government agencies, and outside contractors.

3. Ensures that the most economical and efficient printing process and class of mail for each request is utilized (For assistance in determining the most appropriate class of mail service, please refer to SMG 2250.4, "Selection of U.S. Postal Service Mail Classes and Services").

4. Reviews and approves requests for printing procured from commercial sources on Form HHS-393, "Purchase/Service/Stock Requisition" and for obtaining waivers from GPO for requests over $1,000 (Refer to SMG 2205.3, "Contractor Supplemental Mailings").

5. Collects and compiles all required reports relating to the Agency's printing management program.

C. Headquarters Offices. When requesting the development of new or the revision of existing forms, Headquarters Offices are responsible for:

1. initiating timely requests for forms in order for the FMO to coordinate work schedules with PSC and, if a public-use form, to gain approval from OMB (Prior to date of finalization, external forms typically require one month for design and approval of proof and five months for OMB clearance);

2. coordinating proposed forms with other Centers by requesting the FMO’s assistance in determining whether there are other offices that may be interested in the form, and in helping to resolve issues that may come up in the coordination effort;

3. developing and issuing adequate instructions for use of forms;

4. coordinating proposed forms and procedures with other interested organizations prior to final development and printing;

5. coordinating with Privacy Act and/or Freedom of Information Staffs, and (if a public use form) coordinating with the Paperwork Reduction Act Team; and

6. advising the FDA Forms Management Officer when a form needs to be reprinted or when a form becomes obsolete.

D. Field Offices. Section 11 of this Guide outlines the responsibilities of the field activities for their local forms program.  

6. DETERMINING NEED AND REQUIREMENTS FOR NEW/REVISED FORMS 

Each FDA Office will determine the need for both hard copy and electronic forms required in that organization's area of functional responsibility. A form can be an effective management tool but care must be exercised to ensure that the costs and staff time expended are commensurate with the benefits received. The originator should look beyond the development, printing, and supplies costs and consider the more important costs of:

A. collecting information solicited by the form;

B. completing the form;

C. analyzing and processing the data collected; and

D. utilizing the data.

The originator will coordinate with other interested organizations a proposed form and procedure for its use prior to submitting a request to the FMO for development of the form. The originator may ask the FMO to assist in determining whether there are other offices that may be interested in the proposed form (for example through the FMO’s Center/Office contacts), and to play a part in coordinating the forms if necessary, for example to help resolve issues that may come up in the coordination effort. The FMO will assist in the review and development of the form draft, and give final approval. The originator will decide when to make forms obsolete, and when the use of old editions of forms is allowed.

7. PRINTED FORMS 

All requests for new and revised FDA forms must be submitted to the FMO (HFA-250) for action. Submit a completed HHS-398 "HHS Request for Form Action” to the FMO. Requests for a form action must be submitted as early as possible for external forms. Issuing forms on an emergency basis often results in forms that have not been properly developed and coordinated. A forms action requires one month for design and approval of proof and five months for OMB clearance.

The FMO reviews all forms actions for duplication of existing forms and information systems, effectiveness, and economy from the standpoint of good forms management.

Responsibility for developing new or revised forms is shared by the originating office and the FMO. The FMO decides the final version of a form.

The following steps must be followed to initiate the development of new or the revision of existing forms:

A. Create a draft of the proposed form or data to be collected.

B. Submit a completed HHS-398 "HHS Request for Form Action" to the FMO.

C. Prescribing Directive. Include a copy (or draft) of the prescribing directive, i.e., staff manual guide, memorandum, etc., with every request for a FDA form. This allows the forms analyst to design and construct the form according to the objectives of the directive, and reduce the chance of errors, and consequent later changes and/or corrections.

D. Written Instructions. If appropriate, written instructions should be developed for FDA forms used in more than one office within the Agency. These instructions should accompany the proposed form.

E. Public-Use Report Forms. Forms that collect information from the public, i.e., individuals, businesses, States, etc., are called public-use report forms and require Office of Management and Budget (OMB) approval as prescribed by the Paperwork Reduction Act of 1995. These forms must be submitted to the Center PRA representatives and FDA PRA Analysts (HFA-250) for clearance and submission to OMB for approval before the form can be reproduced. Allow at least five months for this review and clearance process to be completed. The OMB number, expiration date and the public protection provision should be displayed on the front page of the collection of information (21 CFR 1320.3(f)(1)).

F. The Privacy Act of 1974. FDA is responsible for complying with the provisions of the Privacy Act of 1974 with regard to new and revised FDA forms, which are used to collect information that is retained in a system of records. If it is determined that the form does come under the purview of this Act, obtain concurrence of the Privacy Act Coordinator, Freedom of Information Office (HFI-35).

G. Submit the draft of the proposed form or data to be collected to the FMO, along with any prescribing Directive, written instructions, OMB Notice of Action (Approval Notice); and/or concurrence of the Privacy Act Coordinator, Freedom of Information Office.

H. The FMO will forward a final typed copy of the form to be printed to the originator for approval with the approval stamp below on the blank reverse side of the form proof. Completing the items in the approval stamp below certifies approval of the form. The originator may also approve the final typed copy of the form by email to the FMO.

FINAL TYPE COPY APPROVALDATE

OFFICE

 

SIGNATURE

 

I. Preparation of Printing Request. After approval of the final copy, the originator will prepare a HHS-26, "Printing and Visual Services" for printing the form(s) at GPO or a PSC-4, "Reprographics Services Requisition", for printing the form(s) at PSC. Determining the number of forms to be printed may require the coordination of the FMO and the warehouse at PSC Personal Property Facility, 16071 Industrial Drive, Gaithersburg, MD 20877, if the form is one that is used Agency-wide or requested by the public. The originator stores most internal forms that are used in a limited fashion, and usually keeps stocks of FDA forms that are developed for use in only one Center/Office.

J. Printing, Distribution, and Stocking. DHHS/PSC/Printing and Postal Technologies Branch, Printing Procurement Section, Room 3C-60, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857 handles printing for FDA.

When distributing a form(s) by mail, follow Staff Manual Guide: 2250.3 Contractor Supplemental Mailings, 2250.4 Selection of U.S. Postal Service Mail Classes and Services, and/or 2250.5 Format for Printing FDA Return Address (formerly 2420.11). Contact FDA's Mail Manager for further assistance (HFA-215).

Instructions for mailing and disposal of the printed material are included on the form and, when appropriate, a distribution list and/or mailing labels are attached.

The PSC Personal Property Facility will establish a reorder point for stocked forms and notify the FMO when replenishment is required. When the originator stocks FDA forms, that Center/Office will be responsible for initiating appropriate and timely reprint or revision action.

K. Reprinting Forms.

1. FDA Forms Stocked Centrally. The PSC Personal Property Facility warehouse will inform the FMO when a form has reached a reorder point. Based on usage statistics and type of form, the PSC Personal Property Facility will recommend a reorder quantity. The FMO will check on the current status of the form and will request the originator to prepare a form HHS-26, "Printing and Visual Services" or PSC-4, "Reprographics Services Requisition." The originator must notify the FMO, OM/OCIO/PRRMS, (HFA-250), 5600 Fishers Lane, Room 6A-22, Rockville, MD 20857, if a delay in the submission of the printing request is anticipated.

2. FDA Forms Stocked by Originator. When the form has reached a reorder point, the originator will forward a Form HHS-26, "Printing and Visual Services" or PSC-4, "Reprographics Services Requisition." to the FMO at OM/OCIO/PRRMS, (HFA-250), 5600 Fishers Lane, Room 6A-22, Rockville, MD 20857.

L. Forms Ordering Procedures.

1. Order forms from the Internet FDA, "Public Use Forms and How to Obtain Them" web page, and the Intranet FDA Electronic Forms Catalog.

FDA forms that are stocked by the PSC Personal Property Facility warehouse can be ordered by faxing your requests to the FMO at 301-594-0060.

Some forms are stocked by the originating office, which may be contacted by the name and phone number listed in the electronic catalog on the FDA forms web pages.

2. Department of Health and Human Services Catalog. The PSC Forms Download Site provides a list of HHS forms and forms used by other DHHS agencies that may be down loaded. http://intranet.hhs.gov/forms/

3. Electronic forms designed by the FMO are put up on the web site as soon as they are approved by the originating office and by OMB. Responsibility for making forms available on the web is shared by the originating office and the FMO. Originating offices have their own updating procedure for internal forms posted to the web.

4. Copies of all obsolete FDA forms are retained by the FMO for five years after the form is determined to be obsolete by the originating office. Copies of these editions are available on request.

8. ELECTRONIC FORMS 

All requests for new and revised FDA forms must be submitted to the FMO (HFA-250) for action. Submit a completed HHS-398 "HHS Request for Form Action" to the FMO. Requests for a form action must be submitted as early as possible for external forms. Issuing forms on an emergency basis often results in forms that have not been properly developed and coordinated. A forms action requires one month for design and approval of proof and five months for OMB clearance.

All forms actions are reviewed by the FMO for duplication of existing forms and information systems, effectiveness, and economy from the standpoint of good forms management.

Responsibility for developing new or revised forms is shared by the originating office and the FMO. The FMO decides the final version of a form.

The FMO working with the originating office will determine if the form should be electronic and if so what format it should take. The originating office makes the final decision whether a form will be paper, electronic or both.

All revisions are updated on the web by the FMO. Any versions on Center/Office web sites that do not link to the FMO's web site should be updated by the originating office to reflect the same changes that are in the official version.

The following steps must be followed to initiate the development of new or revision of existing electronic forms; or the creation of electronic forms from existing printed forms.

A. Contact the FMO for directions on making the electronic form accessible in compliance with Section 508 of the Rehabilitation Act. In 1998, Congress amended the Rehabilitation Act to require Federal agencies to make their electronic and information technology accessible to people with disabilities. Inaccessible technology interferes with an individual's ability to obtain and use information quickly and easily. Section 508 was enacted to eliminate barriers in information technology, to make available new opportunities for people with disabilities, and to encourage development of technologies that will help achieve these goals. The law applies to all Federal agencies when they develop, procure, maintain, or use electronic and information technology. Under Section 508 (29 U.S. C. 794d), agencies must give disabled employees and members of the public access to information that is comparable to the access available to others (see also Agency Policies on Section 508).

B. Submit a completed HHS-398 "HHS Request for Form Action" to the FMO.

C. Create a draft of the proposed form or data to be collected, in hardcopy or electronically.

D. Prescribing Directive. Include a copy (or draft) of the prescribing directive, i.e., staff manual guide, memorandum, etc., with every request for a FDA form. This allows the forms analyst to design and construct the form according to the objectives of the directive, and reduce the chance of errors, and consequent later changes and/or corrections.

E. Written Instructions. If appropriate, written instructions should be developed for FDA forms used in more than one office within the Agency. These instructions should accompany the proposed form.

F. Public-Use Report Forms. Forms that collect information from the public, i.e., individuals, businesses, States, etc., are called public-use report forms and require Office of Management and Budget (OMB) approval as prescribed by the Paperwork Reduction Act of 1995. These forms must be submitted to the Center PRA representatives and FDA PRA Analysts (HFA-250) for clearance and submission to OMB for approval before the form can be made available electronically. Allow at least five months for this review and clearance process to be completed. The OMB number, expiration date, and the public protection provision should be displayed in the instructions, near the title of the electronic collection instrument or on the first screen viewed by the respondent for on line applications (21 CFR 1320.3(f)(2)).

G. Privacy Act of 1974. FDA is responsible for complying with the provisions of the Privacy Act of 1974 with regard to new and revised FDA forms, which are used to collect information retained in a system of records. If it is determined that the form does come under the purview of this Act, obtain concurrence of the Privacy Act Coordinator, Freedom of Information Office (HFI-35).

H. Database forms. Equipment on which the form is processed should be listed, along with the software used and the structure of the database for review by the forms designer and/or systems analyst for compatibility. The specific parameters and cautions regarding electronically designed forms, that are used for collecting information to be placed in a database, are contained in the General Services Administration (GSA) Information Resources Management Technical Guide, Electronic Forms Systems Analysis and Design (stock number is PB95250239/LP).

I. Creating electronic forms from existing printed forms. Like a photocopy, an electronic reproduction of a form must be complete, containing all instructions and questions that appear on the current official form. The wording and punctuation of all items, instructions, and identifying information must be consistent. Forms printed face and back on the original may be printed on single sheets. Likewise, multiple-part sets may be printed as single sheets, filled out and photocopied. All blocks of information to be filled out should retain their approximate original size as they are filled out. Otherwise this becomes a forms revision and not an electronic version of the same form.

J. Submit the draft of the proposed form or data to be collected, or electronic form to the FMO, along with any prescribing Directive, written instructions, OMB Notice of Action (Approval Notice); and/or concurrence of the Privacy Act Coordinator, Freedom of Information Office.

K. The FMO will coordinate the design of the form and return a hardcopy draft or an electronic version of the form for approval to the originating office. If the form proof is in hardcopy the FMO will forward a final typed copy of the proposed electronic form to the originator for approval with the approval stamp below on the blank reverse side of the form proof. Completing the items in the approval stamp certifies approval of the electronic form. The originator may also approve the final typed copy of the form by email to the FMO.

FINAL TYPE COPY APPROVALDATE

OFFICE

 

SIGNATURE

 

L. The originating office may send approval of the form electronically or by returning the hardcopy with signed approval stamp to the FMO. The FMO will post the form to the FDA Forms Internet and Intranet site if it is a public form or to the FDA Forms Intranet site if it is an internal form.

9. PERIODIC REVIEW OF FORMS 

The FMO will periodically conduct a review of the status and continued need for forms used in FDA, both printed and electronic, in order to clear out space being taken up to store unneeded forms and to update the FDA Internet "Public Use Forms and How to Obtain them" web page and the FDA Intranet Electronic Forms Catalog.

10. DELETION OF OBSOLETE FORMS 

To delete obsolete forms, the originating office should submit a completed HHS-398 "HHS Request for Form Action" disclaimer icon  to notify the FDA's FMO OM/OCIO/PRRMS, (HFA-250), 5600 Fishers Lane, Room 6A-22, Rockville, MD 20857.

11. FORMS MANAGEMENT IN FIELD ACTIVITIES 

Field activities are encouraged to submit recommendations for development of new forms and proposed revisions to existing forms to FDA Headquarters for consideration. Recommendations should be submitted to the Office of the Associate Commissioner for Regulatory Affairs, Division of Management Operations, Administrative Management Branch, HFC-21 or to FDA's FMO OM/OCIO/PRRMS, (HFA-250), 5600 Fishers Lane, Room 6A-22, Rockville, MD 20857.

12. EFFECTIVE DATE 

The effective date of this guide is June 12, 2007.

13. Document History -- SMG 3295.1, FDA Forms Management 

STATUS (I, R, C)DATE APPROVEDLOCATION OF CHANGE HISTORYCONTACTAPPROVING OFFICIAL
Initial06/08/2007N/aElizabeth Sands, OCIO/PRRMSGinger Leo, Deputy Chief Information Officer, OCIO
Change10/08/2008Section Heading 5.A.5; Section Heading 8.AElizabeth Sands, OIM/DBPS/IIB/WMAT

Elizabeth Sands, FDA Forms Management Officer, OIM

Change03/10/2011Sect. Hd 3.C.; Sect. Hd. 5.A.6. Elizabeth Sands, OIM/DBPS/IIB/WMAT

Elizabeth Sands, FDA Forms Management Officer, OIM