NIH POLICY MANUAL

1183 - NIH Publications and Audiovisuals:  Preparation, Review, Approval, and Distribution 
Issuing Office: OCPL  496-4143
Release Date: 02/27/02

1. Explanation of Material Transmitted: The purpose of this revised chapter is to update the policy and procedures to be followed in the preparation, review, approval, and distribution of documents to be issued by NIH and its components, including those prepared and issued under contract. This chapter provides guidance to ensure and maximize quality and effectiveness in NIH publications and audiovisuals, and provides an orderly basis for their review without hampering the free flow of information.

2. Filing Instructions:

Remove: NIH Manual Chapter 1183 dated 03/31/85

Insert: NIH Manual Chapter 1183 dated 02/27/02

PLEASE NOTE: For information on:

• Content of this chapter, contact the issuing office listed above.
• NIH Manual System, contact the Office of Management Assessment, OA, on 496-2832.
• Online information, enter this URL: http://www1.od.nih.gov/oma/manualchapters/

A. Purpose:

This chapter addresses the policy and procedures to be followed in the preparation, review, approval and distribution of documents to be issued by NIH and its components, including those prepared and issued under contract. This chapter has been revised to reflect the OMB Guidelines for Ensuring and Maximizing Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies, (http://www.whitehouse.gov/omb/fedreg/reproducible.html) hereinafter referred to as OMB Information Quality Guidelines. Under these guidelines, agencies must ensure and maximize information quality, and establish administrative mechanisms allowing affected persons (i.e., people who may benefit or be harmed by the disseminated information) to seek and obtain correction of official information. This chapter provides guidance to ensure and maximize quality and effectiveness in NIH publications and audiovisuals, and provides an orderly basis for their review without hampering the free flow of information. Guidelines for responding to formal complaints about NIH information quality are in Chapter 1185 (pending release).

B. Applicability:

This chapter applies to any document that carries the NIH imprimatur. The document can be in the form of a book, chapter of a book or textbook, booklet, brochure, bibliography, collection of abstracts, fact sheet, house organ, index, leaflet, manual, monograph, newsletter, pamphlet, review, periodical, proceedings, recurring report, statistical compendium, internet document, audiovisual, or the like prepared by any NIH component, directly or by contract. It applies to information disseminated in print form, on the websites of NIH and its components, or through any other medium.

The following materials are excluded from the provisions of the chapter:

C. Policy and Procedures:

All NIH documents and audiovisuals must be prepared in accordance with professional and ethical standards, as well as generally accepted standards of good taste. They must be appropriate for dissemination by this Federal agency and must undergo appropriate review and approval prior to release. NIH must adhere to the laws and regulations applying to publications and audiovisuals, including OMB Information Quality Guidelines, the DHHS Printing Handbook, and relevant NIH policy manual issuances. NIH efforts to ensure and maximize information quality begin at the preparation stage, and continue through the review and approval stages. Existing NIH policies developed in concert with Federal computer security laws provide appropriate security safeguards to ensure integrity of NIH documents, i.e., that the information is protected from unauthorized access, revision, corruption, or falsification.

1. Preparation. Each publication must be accurate, both in specific details and in general impressions, and meet accepted standards of high quality. The OMB Information Quality Guidelines define quality as including objectivity, utility, and integrity. 

NIH documents and presentations containing text and summary data must be objective. Sources should be referenced for the convenience and further information of the reader. Where appropriate, supporting data should have full, accurate, transparent documentation. Potential error sources affecting data quality should be identified and disclosed to users. Disclaimers should be used to distinguish the status of information (e.g., based on preliminary data or partial data set). 

OMB Information Quality Guidelines hold “influential” scientific, financial, or statistical information to a higher standard of quality, requiring that the results be “substantially reproducible” by qualified third parties were the original or supporting data to be independently reanalyzed using the same methods. If feasible, making the data and methods publicly available will assist in determining whether analytical results are capable of being substantially reproduced.

Regarding summaries of proceedings or transcripts of meetings, no announcement outside DHHS should be made concerning plans to publish the proceedings or transcript of a conference or symposium sponsored by an NIH component or contractor before completion of the conference and final determination of distribution requirements. Deviation from this provision must be approved by the NIH Institute or Center (IC) director. 

Before an existing publication is reprinted or a new edition and/or revision is prepared, originators should reexamine its contents, including details of format and treatment, and make appropriate additions or changes to ensure that the new edition and/or revision is accurate and conforms to current standards for a new publication.

Plain Language. A Government-wide directive requires Federal agencies to use plain language in all communications with the public. Plain language is writing that is geared to the target audience (i.e., a plain language document for a scientific audience may be different from a plain language document for the general public). Using plain language ensures that your audience can find and understand the information you provide. Plain language is grammatically correct, with accurate word usage. It is also clear and expresses exactly what readers need to know without unnecessary words. Hallmarks of plain language include:

· Common, everyday words, except for necessary technical terms;
· “we,” “you,” and other personal pronouns;
· the active voice;
· logical organization; and
· easy-to-read and understand design features, such as bullets and tables.

Requirements and guidelines for NIH implementation of plain language are given at http://www1.od.nih.gov/execsec/plainlanguage.htm.

Layout and Design: Each publication should be prepared in a pleasing, dignified, and finished format appropriate for its intended use and audience. Use of color and typography must be in accord with Government Printing and Binding Regulations (http://www.house.gov/jcp/jcpregs.pdf).

2. Review. The purpose of the review process is to improve the quality of NIH documents and to ensure the accuracy and validity of information intended to benefit the targeted audience, such as professional societies, and the general public. All materials distributed by NIH must be reviewed for accuracy, propriety, completeness, and quality (including objectivity, utility, and integrity). The structure of the review and the types of reviewers will depend on the nature of the information as well as the targeted audience. 

For scientific and technical documents, peer review provides a level of quality control that is well recognized in the scientific community. According to OMB Information Quality Guidelines, material subject to formal, independent, external peer review can be considered to be of acceptable objectivity. However, this presumption of objectivity is refutable based on a persuasive showing by a complainant in the particular instance. The single most important determinant of a review group’s excellence and credibility are its members. Reviewers must have appropriate scientific knowledge (as demonstrated by grant and publication record, and academic degrees and honors), respect in the scientific community, breadth of expertise, be fair and objective, and should not be influenced by inappropriate personal interests (competition, scientific bias, personal antagonisms, or similar irrelevant factors). Because utility is one measure of quality, the review group should include representative(s) of the targeted audience to the degree practicable.

Statistical compendia and documents providing “influential scientific, financial, or statistical information” must be reviewed carefully. The Director of the originating IC must determine that the data conforms to the standards set forth in this chapter, and if applicable, that the reported information and/or statistics be substantially reproducible.

You are encouraged to seek advice on any additional review procedures specific to your IC from your IC communications director. OD employees should seek advice from the NIH Office of Communications and Public Liaison (OCPL).

3. Approval. Each IC publication or audiovisual must be approved by the Director of the originating component or by the Director’s designee. When the subject matter of a presentation overlaps with the program of another NIH component, another Federal agency, or any non-Federal agency or private individual, the concurrence of such component, agency or individual must be obtained by the originating office before submission of the proposed publication to OCPL/OD/NIH. A proposal for a publication or audiovisual to be prepared under contract should be reviewed and approved in OCPL/OD/NIH prior to contract preparation. 

Prior to being set in type, prepared for camera-ready copy, printing, or production, each IC publication or audiovisual must be approved by OCPL/OD/NIH, and the Office of the Assistant Secretary for Public Affairs (OASPA), DHHS. This also applies to reprints and new editions and/or revisions of existing publications or audiovisuals.

a. Publications: For each official publication, the originating office must:

o Submit to the NIH OCPL Editorial Operations Branch (Bldg 31, 5B52) three (3) copies of a completed Publication Planning and Clearance Request (Form HHS-615, available at http://intranet.hhs.gov/forms/HHS/HHS-615.pdf). This applies to any new publication, reprint, new edition, and/or revision. OCPL will forward to OASPA for review. Even if your request is approved conditionally – that is, if OASPA requires you to make changes to your publication plan – there is no need to resubmit the HHS-615.

o Submit one (1) set of a completed Request for Publication and Speech Clearance (Form NIH 1616-1, available at http://forms.cit.nih.gov/adobe/procurement/NH1616_1.pdf), along with a paper copy of the text and captions. Form 1616 should carry the signatures of appropriate officials within the originating IC, including that of the IC Director of designee. Your manuscript will be reviewed and returned within 7-10 days with any requested changes clearly marked. 

o Work with your IC Administrative Officer to generate a Central Services Activities (CSA) Request – Printing, also called a “P” number (See http://www.nih.gov/od/ors/dss/repro/procedures.htm for detailed procedures). Submit the CSA request, along with camera-ready copy, to the Editorial Operations Branch (Bldg 31, Room 5B52). Even if you are submitting your publication to the printer on diskette, you are required to submit to the Editorial Operations Branch a paper copy of the text layout, any illustrations, a dummy layout of front and back covers, title page, preface, foreword, introduction, contents page(s), and any other material to appear in your publication. Your package will be reviewed and returned with a signature indicating that it is ready to take to print.

o Except for printing done in-house, submit three (3) copies of a completed Notification of Intent to Publish for the Superintendent of Documents, U.S. Government Printing Office (GPO Form 3868, available at http://forms.psc.gov/forms/GPO/ps3868.pdf) to the Editorial Operations Branch (Bldg 31, Room 5B52).

b. Periodical Publications:

(1) New Periodicals. Section 1108, Title 44, U.S.C., as amended, prescribes the policies and procedures for funding government periodicals (including journals, magazines, and similar publications), and assigns the Office of Management and Budget (OMB) responsibility for approving the preparation and release of periodicals. OMB has delegated the responsibility for approving all proposals for new HHS periodicals and all requests for extending the life of existing HHS periodicals to the Secretary.

(2) Established Periodicals. Approval by OCPL/OD/NIH is not required for each issue of an established periodical. However, the Director of the originating IC or the Director’s designee is required to determine that each issue fulfills the objectives originally set for the periodical and conforms to the standards set forth in this chapter.

(3) Newsletters and Information Bulletins. A proposal for the establishment of a newsletter or similar informational bulletin must be submitted to OCPL/OD/NIH for approval.

c. Electronic Publications: Internet postings of approved printed publications do not need additional approvals. Internet documents with no print counterpart require content clearance by the appropriate IC office(s) to ensure that the information observes all applicable requirements governing information for release to the public. For IC Web pages relating to more than one IC (e.g., trans-IC publications, special interest groups), the appropriate contact person for the primary IC responsible for creating the Web page shall be notified for clearance requirements. (See also World Wide Web NIH Guidance, April 15, 1998, http://irm.cit.nih.gov/policy/guideli2.html).

d. Audiovisual Materials, Including Exhibits. All NIH Audio/Visual projects and exhibits must be cleared through OCPL/OD/NIH and OASPA, whether produced in-house or under contract. To obtain clearance, submit Form HHS 524A (http://www.nih.gov/od/ocpl/resources/audiovisual.htm) to OCPL’s News Media Branch (Bldg 31, Room 5B52). Upon satisfactory review, OCPL will forward this to the Office of the Assistant Secretary for Public Affairs for approval. OASPA approval must be obtained before actual production may begin. If the cost exceeds $50,000, a written evaluation plan is required. If more than $100,000 is involved, a written evaluation and formal message testing are required. No subsequent change in terms, dollar amounts, conditions, or additions can be made to the product without written approval of OASPA. Contact the appropriate IC or OD communications director for additional guidance.

4. Distribution: The number of copies to be printed should be based on the amount needed for: distribution to professional, scientific, or general groups; answering inquiries; and other specific purposes. Sufficient quantities should be ordered to achieve maximum effectiveness without frequent reprinting. Overprinting of materials with limited demand, or with the likelihood of rapidly becoming obsolete, should be avoided. Approving or authorizing officials shall avoid unnecessary and unproductive expenditures for a publication and duplication of a publication issued by another Federal or non-Federal agency.

In addition to the distribution for which the publication is planned, copies of each NIH publication should be distributed as follows:

o Two (2) copies to the Technical Services Division, National Library of Medicine, Bldg. 38, Rm. 1N17.

o One (1) copy to the Technical Services Section, NIH Library, Bldg. 10, Rm. 1L09.

o One (1) copy to the Editorial Operations Branch, PIO, OCPL, OD, NIH, Bldg. 31, Rm. 5B52.

o Five (5) copies to the Medical Arts and Photography Branch, Division of Intramural Research Services, Bldg. 10, Rm. B2L316.

NIH Manual Chapter 6308, Acquisition of Printing Requirements at the NIH, requires that government publications (except those determined to be required for strictly administrative purposes having no public interest or educational value, and documents classified for reasons of national security) must be made available to the Federal Depository Library Program (FDLP) of the GPO Library Service, the Library of Congress and the Cataloging and Indexing Program (C&I). Compliance with these requirements is assured for acquisition of printing for Centers and other NIH entities, solely due to the need for interaction with the NIH Printing Officer, Central Printing and Publications Management Office (CPPMO). However, Institutes that choose to contract for printing from sources other than the GPO must provide the copies of these publications to the sources noted above, and report such publications to the CPPMO as a part of their own duties. See NIH Manual Chapter 6308 for specific instructions regarding this requirement.

D. Publications by NIH Contractors: Each publication or audiovisual prepared and distributed for an NIH component by a contractor must: 

· meet all of the requirements of this chapter, including the DHHS and NIH identifications;

· be free of advertising and all identification with the contractor that is not relevant to the publication or the publication contract; and

· be copyright free and mailed separately from other materials produced by or identified with the contractor.

E. Identification:

1. DHHS and NIH. Each publication intended for distribution outside DHHS must clearly identify the originating organization as a component of NIH and DHHS. The words "U.S. Department of Health and Human Services," and "National Institutes of Health" (departmental imprint) must appear in full and in that order on the cover, with NIH identifications below the DHHS identification. The Department name should appear in more conspicuous type. The identical type face should be used for all identifications. The following is an example: 

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES 
National Institutes of Health

Each publication intended for external distribution must carry a publication number--NIH Publication No. XX-XXXX--assigned to it by the Editorial Operations Branch, Public Information Office (PIO), Office of Communications and Public Liaison (OCPL), OD, NIH, on the back cover and title page, if any.

2. Placement of Identification. Each publication shall have the "departmental imprint" on the front cover. Printed material that has a self-cover shall have the identification information on the first printed page. If a publication contains a title page, the cover identification should be repeated on the title page with whatever other identification information is appropriate, i.e., the appropriate Institute or Center. No personal name shall be printed on the cover of a publication. This does not apply to identifying authorship on title pages. Exceptions may be granted only by the Office of the Assistant Secretary for Public Affairs (OASPA), DHHS. 

Identification of the originating component and subcomponent is appropriate on the title page, but should not appear on the front cover. Exceptions may be made when the component name is incorporated into the title or when the nature of the subject matter justifies use of the component name. An IC logo may only be on the title page or back cover -- with the exception of the DHHS or NIH logo. Design of a logo should be in accordance with the Congressional Joint Committee on Printing (JCP) guidelines for illustrations (See Item 19, http://www.house.gov/jcp/jcpregs.pdf).

3. Self-Covers. In accordance with Government Printing Office regulations, printed material of 16 pages or less in length shall have a self-cover, using the same paper stock used for the text.

4. Logos. The official DHHS seal is intended for use on certificates and other official documents. A variation of the seal has been issued as a DHHS logo. Use of a logo on a cover or title page does not substitute for identifications required under Section E.1 above. The Department logo may appear on pamphlets, posters, periodicals, booklets, exhibits, and public affairs related materials. See NIH Manual 1113.

5. Photographs. A portrait photograph may be published according to JCP regulations. Any photograph showing employees engaged in official duties may be published for illustrative purposes (See Item 19, http://www.house.gov/jcp/jcpregs.pdf).

6. Acknowledgements and Credit Lines. Each publication must be presented as a product of NIH or one of its components. Personal acknowledgements and credits may be included to recognize unusual contributions and should be limited to the person's name and a brief description of the contribution. Collective credit to all persons connected with a project of the staff of any unit or group should be avoided. 

a. NIH Employees and Contractors. Any suggestion that an individual employee is being given personal publicity or that NIH is thanking its employee(s) for performing assigned duties must be avoided. Except for extenuating circumstances, there should be no mention or acknowledgement of an employee or contractor for: contributions such as typing, proofreading, or copy editing; sharing or loans of equipment, materials or services; or normal advice and courtesies. Administrative and supervisory personnel such as a chief of a section, branch, or laboratory should not be named in any publication produced by the individual's organizational component, except in a directory or other publications showing organizational relationships. 

An employee or contractor who actively participates in the preparation of a publication may be identified under the following circumstances: 

(1) The person's stature is such that the publication would gain acceptance or attention because of the individual's connection with it, or whose identification would establish or add validity or authority to the contents.

(2) The person is responsible for all or part of the publication, for example as editor of a collection of scientific reports or the proceedings of a conference on a subject in which the person is knowledgeable and experienced.

(3) The person is the author of an original report, chapter, or article for purposes of identification of authorship.

(4) The person is responsible for the design of a survey, analysis of data, statistical compilations, or the conduct of other projects in which it is desirable to indicate that a particular design or treatment has been used.

b. Persons Not Employed by NIH. Acknowledgements or expressions of thanks to persons not employed by or under contract to NIH may be published in accordance with provisions set forth in this paragraph (Section E.6). Publications produced under NIH grants, while not covered by this chapter, are subject to acknowledgement requirements. See PHS Grants Policy Statement (http://grants.nih.gov/grants/policy/nihgps_2001).

F. Nondiscrimination Compliance Statement: Each recruitment publication must carry a statement in the text that the originating component or program does not discriminate in employment on the grounds of race, color, religion, national origin, sex, handicap or age.

Except for recruitment publications, each publication that relates to programs or activities financially assisted by the Federal Government must include the following statement, printed in a box and not incorporated in the text, and preferably in boldface type, on the inside front cover or inside back cover.

DISCRIMINATION PROHIBITED: Under provisions of applicable public laws enacted by Congress since 1964, no person in the United States shall, on the grounds of race, color, national origin, handicap, or age, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity (or, on the basis of sex, with respect to any education program or activity) receiving Federal financial assistance. In addition, Executive Order 11141 prohibits discrimination on the basis of age by contractors and subcontractors in the& performance of Federal contracts, and Executive Order 11246 states that no federally funded contractor may discriminate against any employee or applicant for employment because of race, color, religion, sex, or national origin. Therefore, the [specify the particular program covered in the publication] must be operated in compliance with these laws and Executive Orders.

G. Records Retention and Disposal: All records (e-mail and non-e-mail) pertaining to this chapter must be retained and disposed of under the authority of NIH Manual 1743, "Keeping and Destroying Records," Appendix 1, NIH Records Control Schedule, Item 1100-B-1, "Policy Files."

NIH e-mail messages: NIH e-mail messages, (messages, including attachments, that are created on the NIH computer systems or transmitted over the NIH networks) that are evidence of the activities of the agency or have informational value are considered Federal records. These records must be maintained in accordance with current NIH Records Management guidelines. Contact your IC Records Officer for additional information.

All e-mail messages are considered Government property, and if requested for a legitimate Government purpose, must be provided to the requester. Employees' supervisors, the NIH staff conducting official reviews or investigations, and the Office of Inspector General may request access to or copies of the e-mail messages.

E-mail messages must also be provided to the Congressional Oversight Committees, if requested, and are subject to the Freedom of Information Act requests. Since most e-mail systems have back-up files that are retained for significant periods of time, e-mail messages and attachments are likely to be retrievable from a back-up file after they have been deleted from an individual's computer. The back-up files are subject to the same requests as the original messages.

H. Management Controls: The purpose of this Manual issuance is to provide updated guidance on the policies and procedures to be followed in the preparation, review, approval, and distribution of publications issued by NIH and its components, either directly or under contract.

1. Office Responsible for Reviewing Management Controls Relative to this Chapter: The NIH Office of Communications and Public Liaison (OCPL) is accountable for the method used to ensure that management controls are implemented and working.

2. Frequency of Reviews: Ongoing

3. Method of Review: OCPL evaluates input from users based on e-mail, telephone calls, meetings and memoranda, and makes appropriate changes as needed.

4. Review Reports: Are sent to DDM upon request.

I. References:

1. Office of Management Budget Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies. Final Guidelines. Effective January 3, 2002. http://www.whitehouse.gov/omb/fedreg/reproducible.html

2. NIH Policy Manual Chapter 1185, Complaints About NIH Information Quality, pending release.

3. NIH Policy Manual Chapter 1184, Scientific and Professional Information Presented by NIH Employees: Review, Approval, and Distribution.

4. 45 CFR Part 73 Standards of Conduct (for DHHS employees) published in the Federal Register of January 23, 1981, as revised. This was last revised October 1, 2000.  http://www.gpoaccess.gov/cfr/index.html

5. Government Printing and Binding Regulations issued by the Joint Committee on Printing (JCP), Congress of the United States, February 1990, No. 26. http://www.house.gov/jcp/jcpregs.pdf

6. Guidelines for Using Plain Language at NIH, August 8, 2000. 
http://execsec.od.nih.gov/plainlang/guidelines/

7. NIH Policy Manual Chapter 6308, Acquisition of Printing Requirements at the NIH

8. DHHS Printing Handbook, September 1998. 
http://intranet.hhs.gov/progorg/oirm/printing/handbook.html

9. NIH Manual Chapter 1130 Delegation of Authority, Program: General No. 3, Publish Articles and Results of Scientific Research, and Program: General No. 4, Availability of Records for Examination or Copying (both dated June 12, 1985). 

10. World Wide Web NIH Guidance. April 15, 1998. http://irm.cit.nih.gov/policy/guideli2.html

11. NIH Grants Policy Statement, as revised. This was last revised March 1, 2001. 
http://grants.nih.gov/grants/policy/nihgps_2001/

NIH