FDA STAFF MANUAL GUIDES, VOLUME III - GENERAL ADMINISTRATION ADMINISTRATIVE SERVICES OFFICE SERVICES PUBLICATIONS AND AUDIOVISUAL CLEARANCES

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1 SMG FDA STAFF MANUAL GUIDES, VOLUME III - GENERAL ADMINISTRATION 1. PURPOSE ADMINISTRATIVE SERVICES OFFICE SERVICES PUBLICATIONS AND AUDIOVISUAL CLEARANCES Transmittal Number Date: 10/27/ Purpose 2. Background 3. Definitions 4. Policy 5. Responsibilities 6. Procedures 7. Clearance Procedures Summarized 8. Desktop Publishing This guide states the policies and establishes the procedures for tile review and approval of publications, audiovisual materials, exhibits, and public affairs service contracts within the Food and Drug Administration (FDA) and for identifying and submitting to HHS those publications, audiovisual materials, exhibits, and public affairs contracts requiring further approval by the Public Health Service and the Office of the Assistant Secretary for Public Affairs (OASPA). This guide updates previous procedures in keeping with the Department's Public Affairs Management Manual dated November BACKGROUND HHS, through the Office of the Assistant Secretary for Public Affairs, requires that the above-mentioned materials developed by HHS component agencies and intended for general distribution follow certain clearance procedures and designates agency public affairs offices as the channels through which this is to be accomplished. These FDA clearance procedures were developed for that reason. Also, good management requires that FDA set certain standards for the design, content, and distribution of public affairs materials. 3. DEFINITIONS A. FDA Component: As used in this guide, an FDA component is the Office of the Commissioner, the Office of Public Affairs, the Office of Regulatory SMG (TN 87-56, 10/27/1987) 1

2 Affairs, the Office of Management and Operations, the Office of Consumer Affairs, the Office of Planning and Evaluation, the Office of Health Affairs, the Center for Drugs and Biologics, the Center for Food Safety and Applied Nutrition, the Center for Devices and Radiological Health, the Center for Veterinary Medicine, the National Center for Toxicological Research, and FDA Regional and District Offices. B. Publications: Items of printed information in the form of books, periodicals, pamphlets, brochures, newsletters, reports, circulars, posters, or fact sheets, carrying the Department's name as the publisher or in which the Department has proprietary interest whether written or publisher in the department or outside, regardless of how financed. "Printed information" in this context includes microfilm publishing. The Government Printing and Binding regulations require that all publications printed at government expense identify the issuing office and the date of the publication; for FDA publications, the Public Health Service and the Department must also be identified. Excepted from the category of publications are publications that are for internal, administrative use, such as employee memos and journal articles, as well as speeches, news releases, scripts for radio or TV programs, and other items that may be exempted in writing by the Assistant Secretary for Public Affairs. However, news releases are susubject to separate clearance procedures and must be submitted to the Associate Commissioner for Public Affairs. Radio and TV scripts are also subject to approval by the Associate Commissioner for Public Affairs. C. Periodical: Any publication issued annually or more often with a format, content, and purpose consistent in nature. This also includes any publication that is reprinted due to a need for substantial revisions. D. Reprint: Any published document essentially unchanged from the previous printing. E. Revision: Any published document with text and/or graphic changes since the previous printing. F. Audiovisual: Motion pictures, filmstrips, sound recordings, multimedia presentations, videotapes, slide presentations, photographs, graphs, illustrations and similar materials, and such materials of a public affairs/communications nature whose purpose is the dissemination of information. Excluded are slides, graphs and charts, and charts that are produced to illustrate a speech or are for one-time use only. G. Exhibit: Any display, device or structure designed to inform or educate any audience. SMG (TN 87-56, 10/27/1987) 2

3 H. Employee-Related Materials: All magazines, newsletters, fact sheets, and publications such as guides, introductions to the various components of the department, awards materials, training materials, handbooks, and internal posters. I. Administrative Materials: These include department and operation division catalogs and manuals (except those of a purely technical nature and those whose distribution is limited to within the department). J. Public Affairs Service(s) Contracts: A legal agreement to spend HHS funds through a contract or procurement order for any publication or audiovisual services under terms of this section, such as graphic and design services, clipping services, editorial services, multimedia campaigns, polling, duplication, speech writing, photographic services, editing, planning and strategy, and research and evaluation having to do with public affairs. 4. POLICY It is FDA policy to develop public affairs programs that meet the needs of the agency' s regulatory programs and the information needs of technical audiences, other agencies, the public, and industry. It is also FDA policy to encourage prompt dissemination of technical and program information resulting from the work of agency grants and contracts relating to consumer protection and industry regulations. 5. RESPONSIBILITIES A. The Associate Commissioner for Public Affairs (ACPA), as required by HHS, is responsible for the development and issuance of FDA clearance procedures described in this guide, and for clearance of FDA publications, audiovisual materials, exhibits, and materials prepared under public affairs service contracts. B. Associate Commissioners, Center Directors, Regional Food and Drug Directors, and District Directors are responsible for adherence to the procedures described herein. Associate Commissioners and Center Directors have the authority to clear, for policy purposes and technical accuracy, publications intended solely for technical and scientific audiences. C. The Director of the Center for Devices and Radiological Health is responsible for issuing procedures applicable to in-house production of FDA videotapes after the appropriate concept clearance has been obtained by a requesting component. SMG (TN 87-56, 10/27/1987) 3

4 D. Each FDA component as defined earlier is responsible for maintaining necessary files and records on its own publications and audiovisual materials, including file copies of such items and the documents that accompany them. 6. PROCEDURES A. Annual Analysis: Each FDA component is expected to analyze at least annually its publications and audiovisual needs and to develop programs appropriate to these needs. The Office of Public Affairs will assist, upon request, in planning such programs. B. Publication Review: The publication review procedure begins while a publication is still in the planning and concept stage, and before any major funds have been expended, with submission of a completed HHS Form 615 (Publication Planning and Clearance Request) to the Director of the Communications Staff (HFI-40) in the Office of Public Affairs. The Director is responsible for reviewing the form as to adequacy and submitting it to the Public Health Services' Public Affairs Office, which in turn submits it to the Office of the Assistant Secretary for Public Affairs. Approved items are returned to HFI-40. Work on a publication should be limited until the approved Form 615 has been received by the agency. In some instances, the Office of Public Affairs will require clearance of the final manuscript or design. Prints and revisions that are to be printed and distributed by the agency or a component are included in this process. C. Periodicals: Periodicals as defined in 3(c) above require sanction from the White House Office of Management and Budget as well as prior approval by me agency, PHS, and HHS. Guidelines for establishing a periodical are spelled out in OMB Circular A-3. Approvals for periodicals are usually granted by OMB on a lang-term basis. D. Audiovisuals: Clearances for audiovisuals begin with completion of an HHS form 524-A (Audiovisual Clearance Request). The fill-out form is to be submitted to the Director of the Communications Staff in OPA for review and forwarding, when appropriate, to the PHS Public Affairs Office and OASPA. The Communications Staff is notified when requests are approved. As with publications, work on audiovisuals should be limited until approval has been received, and in some cases the Office of Public Affairs will require clearance of the script for an audiovisual. Only these projects in which production funds are more than $5,000 need to be forwarded to PHS and OASPA for approval. However, a 524-A must be completed for projects below $5,000 and submitted to the Director of the Communications Staff for review and approval. In addition to the 524-A requirement, pre- and post-reporting requirements involving forms 282 and 202 must be met for all projects of $5,000 or more. These SMG (TN 87-56, 10/27/1987) 4

5 requirements, and other audiovisual controls, are spelled out in OMB circular A-114 dated March 20, E. Contracts: Form 524-B is to be used for public affairs service contracts and procurement orders as defined in 3(j) above. The filled-out form is to be submitted to HFI-40 for review and approval. Those projects of more than $5,000 will be sent to PHS and the Department for approval. F. Exhibits: The clearance procedure for exhibits involves completion and submission of a form 524-A. If done under a public service contract (see 6(e) above), a form 524-B must be submitted for approval before submitting the 524-A. A system of maintaining schedules of exhibit showings is called for in the Public Affairs Management Manual (HHS Transmittal 86.D1 [11/11/86]), and this responsibility is delegated to the Consumer Affairs and Information Staff of the Office of Regulatory Affairs (HFC-11O). G. Employee-Related Materials: These materials were previously exempt from clearance procedures but are now included. Form 615 should be used for clearing these materials, which are defined under 3(h) of this guide. H. Administrative Materials: Also previously exempt, these materials require completion and approval of form 615. See 3(i) of this guide for definitions. 7. CLEARANCE PROCEDURES SUMMARIZED A. The originating office completes HHS form 615 for publications, form 524- A for audiovisuals, or form 524-B for public affairs service contracts. NOTE: In completing forms 615 and 524-A, it is important to be thorough in responding to the justification section of each form (item 9 in the 615 and item 5 in the 524-A). That response should be the point by point, with each point identified as on the form. B. The completed form is processed through the clearance system of the originator's office, center or other component. C. The completed form is forwarded with approvals to the Director, Communications Staff, HFI-40, Office of Public Affairs, for approval at agency level. HFI-40 will forward it, when appropriate, for approval at the PHS and HHS levels. D. OPA will inform the originating office of the approval or disapproval of a project by the department or PHS. SMG (TN 87-56, 10/27/1987) 5

6 E. If the project is a publication, the originating office obtains a publication number from HFI-40. F. The originating office provides HFI-0 with file copies for the record when the project has been completed. 8. DESKTOP PUBLISHING New technology has created a capability of in-office preparation of original copy that can be produced on a laser printer. This is commonly known as desk-top publishing. The Joint Committee on Printing, a Congressional entity that controls government printing, requires that all purchases of laser printing equipment be registered with Department and PHS printing officials. Thus, any agency purchase of such equipment must be recorded by the PHS Printing and Reproduction Management Branch in the Parklawn Building, which is required to report such purchases to the Office of the Secretary. SMG (TN 87-56, 10/27/1987) 6