- Explanation of Material Transmitted: This revised chapter updates the policies and procedures required for recommending, creating, managing, monitoring, and eliminating NIH forms used within the National Institutes of Health (NIH), U.S. Department of Health and Human Services (HHS). The chapter contains website references for many types of electronic and/or digital forms that align with the HHS e-Gov Policy and 21st Century IDEA Act. This chapter does not cover Public Use Forms (see definitions).
- Filing Instructions:
Remove: NIH Manual 1730 dated 7/31/2013.
Insert: NIH Manual 1730 dated 02/23/2023.
PLEASE NOTE: For information on:
- Content of this chapter, contact the issuing office listed above or visit https://oma.od.nih.gov/DMS/Pages/Forms-Management.aspx.
- NIH Policy Manual, contact the Management Operations Branch, Division of Compliance Management, OMA at 301-496-4606, firstname.lastname@example.org or enter this URL: https://oma.od.nih.gov/DMS/Pages/Manual-Chapters.aspx.
This chapter describes the policies and procedures required for requesting new forms for use internally to NIH, through the NIH Forms Program, and for managing official NIH-wide forms. NOTE: In accordance with OMB/NARA M-23-07, Update to Transition to Electronic Records as of June 30, 2024, to the greatest extent possible, all federal forms must be created, maintained, and stored in electronic format.
This chapter applies to all NIH personnel creating, revising, or rescinding electronic and fully accessible forms for use within NIH. For this chapter, an “NIH form” is defined as:
- NIH-wide forms. The main focus of the NIH Forms Management Program is forms designed for NIH operations across the NIH enterprise. An NIH-wide form is only produced when no other suitable form is available from other federal sources.
- Specific ICO forms. The scope of this chapter also applies to specific forms created on request by an NIH Institute, Center, or OD Office (ICO) for their unique use through the NIH Forms Management Program, as agreed to by the NIH Forms Officer.
All NIH forms must be:
- Issued and used in accordance with all applicable laws, regulations, and policies;
- Created and revised as needed to maintain accessibility compliance;
- In compliance with Privacy Act requirements and policies regarding public use;
- Used only when they will increase efficiency in collecting, storing, disseminating, or using information; increase productivity, advance the quality of operations, or improve the effectiveness of operations; and,
- Designed to minimize costs and time associated with production, storage, and distribution.
D. Privacy Requirements
- NIH forms are subject to the Privacy Act of 1974, as amended:
The purpose of the Privacy Act is to protect the privacy of personally identifiable information (PII) held by the Federal Government by establishing “fair information practices” for the collection, maintenance, use, storage, and transmission of information by agencies. When creating or revising a NIH form, the originating office in the ICO must consult with their Privacy Coordinator to determine whether a form is subject to the Privacy Act. An NIH form is subject to the Privacy Act if it:
- Is under the control of an ICO;
- Asks the subject individual to provide PII; and
- Is designed to retrieve information about the subject individual by name or an identifier linked to them (i.e., timekeeper number, taxpayer identification number, medical record number, principal investigator number, home address, personal/mobile phone number, personal e-mail address).
- When an NIH form requests information subject to the Privacy Act, the form must include a Privacy Act statement. In accordance with OMB Circular A-108, the Privacy Act statement must include a plain-language description of:
- The authority (whether granted by statute or executive order) that authorizes the solicitation of the information and whether the disclosure of such information is mandatory or voluntary;
- The primary purpose for which the information is intended to be used;
- A summary of the published routine uses to which the information is subject;
- The effects on the individual, if any, of not providing all or any part of the requested information, and
- An appropriate citation (and, if practicable, a link) to any relevant System of Records Notice (SORN).
- Generally, agencies may not collect information regarding how individuals exercise rights guaranteed by the First Amendment, subject to limited exceptions. Accordingly, the originating office must consult with their NIH ICO Privacy Coordinator prior to developing a form that collects information regarding how individuals exercise rights guaranteed by the First Amendment, to ensure the form satisfies the stringent requirements of the Privacy Act, subsection (e)(7).
The limited exceptions to this requirement are if:
- A statute explicitly authorizes the agency to maintain such a record; as it is not sufficient if the information is relevant to an authorized activity;
- The record is required by the agency for an authorized law enforcement function; and,
- The individual expressly authorizes or knowingly volunteers the information.
E. Roles and Responsibilities
- The NIH Forms Officer, leads the NIH Forms Management Program, Information Management Branch (IMB), Division of Compliance Management (DCM), Office of Management Assessment (OMA), Office of Management (OM), Office of the Director (OD), is responsible for the overall operation of the NIH forms management program. Specifically, the NIH Forms Officer:
- Develops and coordinates policy for NIH forms;
- Provides centralized control of the creation, revision, and numbering of NIH forms;
- Oversees the management of the NIH Electronic Forms Home Page, a centralized digital site for NIH forms and other forms used by the NIH community;
- Ensures that the finalized and fully accessible, approved NIH form is posted to the NIH forms website;
- Communicates as appropriate with a federal third-party vendor in creating a new NIH form or updating an existing NIH form in an electronic format;
- Clears all policies that cite a NIH form to ensure that the most current and fully accessible version of the form is referenced; and
- Establishes and maintains historical files for rescinded NIH forms.
- The originating NIH Office within the ICO:
- Determines that a new form, or modification to an existing form, is needed for NIH-wide operations, and submits the following information to the NIH Forms Officer, through the Forms Management site at https://oma.nih.gov/dms/programs/forms/Pages/New-Form-request.aspx.
- Obtains necessary clearances (e.g., Privacy Act);
- Describes the need for the NIH form, including whether it is replacing an existing NIH form;
- Provides formatting instructions;
- Notifies the NIH Forms Officer when a form become obsolete, is superseded, or needs revisions;
- Ensures that any questions related to protected categories (e.g., gender, age, race, nationality, disability, sexual orientation) are necessary and justifiable; and,
- Provides a copy of the OMB approval notice to the NIH Forms Officer with any request to create or revise a public use NIH form.
- The NIH ICO Privacy Coordinator is responsible for reviewing new and revised form proposals originating from their ICO to determine if the form will be subject to the Privacy Act, advising on the requirements of the Privacy Act, and reviewing all proposals for new, revised, or reprinted NIH forms that are subject to the Privacy Act using the checklist in Appendix 1. Privacy Coordinator will determine if the form is subject to the Privacy Act and if, so will advise on Privacy Act requirements.
- The NIH Privacy Act Officer must authorize any needed alteration to a system of records following procedures in OMB Circular No. A-108, Federal Agency Responsibilities for Review, Reporting, and Publication under the Privacy Act.
- Third-party Vendor for accessibility compliance:
NIH currently has an interagency agreement for the production of a new NIH form (or edits and corrections to an existing NIH form) for accessibility compliance. The NIH Forms Officer works with the third-party vendor to finalize the form for accessibility compliance through:
- A draft form (either in Microsoft Word or Adobe PDF format);
- Reference to any policies relating to the form (such as an NIH Manual Chapters for Records Management and Privacy);
- Justification for the new form creation (or for updating an existing form) including specific formatting, requestor name, email, and phone number, and authorization from the Deputy Executive Officer, Budget Officer, or Administrative Officer.
- All NIH personnel, must Report any accessibility access issues or errors in NIH forms to the NIH Forms Officer
When a requesting NIH office determines that a new form, or modification to an existing form, is needed for NIH operations, the requesting office must:
- Submit the following information to the NIH Forms Officer, through the Forms Management site at https://oma.od.nih.gov/DMS/Pages/Forms-Management.aspx:
- A draft, either in Microsoft Word or Adobe PDF format;
- Reference to any policies relating to the form;
- Justification for the new form creation or for updating an existing form; including specific formatting, requestor name, email, and phone number;
- Authorization from leadership within the originating NIH Office (Deputy Executive Officer, Budget Officer, or Administrative Officer); and,
- Collaborate with the NIH Forms Officer to ensure that the finalized, approved, and fully accessible form is posted to the NIH Forms website.
G. Formatting Requirements
Contact the NIH Forms Officer with questions regarding:
- Title — Each NIH form must show a title that concisely describes the function or purpose of the form.
- Numbering — The number is routinely located in the lower-left corner of all pages of the form. All NIH-wide forms have “NIH” as a prefix. A series of related forms may be assigned a number with suffixes.
For example: The following three forms are all used to apply for parking permits and have the same root number, NIH 2788. They are distinct forms for different groups of users. The suffixes, -1, -2, and -3, make their forms unique:
- NIH 2788-1 - Renewal for Parking Permits for General Permits, Off-Campus Permits, Red Permits, and Satellite Permits;
- NIH 2788-2 - Request for Campus Parking Permit for Contract Employees;
- NIH 2788-3 - Mail-in Renewal for Carpool Permits.
- Date — NIH forms are identified by the month and year in which they were originated or revised. This date is shown on the form next to the form number and is put in parentheses. When a form is revised, the new date is preceded by “Rev.”
- Privacy Act Systems of Record Numbers — NIH forms that are used in systems of records, as defined by the Privacy Act, must display any system number assigned to the system of records. The NIH Privacy Act Officer assigns systems numbers to NIH systems of records.
- Accessibility - Section 508 Compliance — All federal digital/electronic online forms must be fully accessible and compliant with Section 508 of the Rehabilitation Act of 1973. Section 508 compliance ensures the elimination of barriers in information technology and communications (ICT), the opening of new opportunities for people with disabilities, and encourages the development of technologies that will help achieve these goals. For support on creating fully accessible and Section 508 compliant forms, please visit https://www.hhs.gov/web/section-508/accessibility-checklists/index.html.
H. Forms Availability
Most NIH-wide forms are available on the NIH forms website, at https://oma.od.nih.gov/DMS/Pages/Forms-Management.aspx. For all other NIH forms, contact the NIH Forms Officer, at 301-496-4606, or email NIHFormsManagement@od.nih.gov for additional information:
- All forms are available in fillable format and are fully compliant with federal accessibility requirements. If there are any issues with this format, please contact the NIH Forms Officer at FormsManagement@od.nih.gov.
- Per form formatting, the most recent edition date is typically on the bottom left. New editions of a form will replace all previous versions and make them inactive.
I. Records Retention and Disposal
All records that pertain to this chapter must be retained and disposed of under the authority of NIH Manual 1743, “Managing Federal Records”.
These records must be maintained in full compliance with current NIH Records Management guidelines. If necessary, backup file capability should be created for this purpose.
Forms that are created on NIH information systems or transmitted over NIH networks (that are evidence of the activities of the agency or have informational value) are considered Federal Records.
Contact the appropriate Records Liaison within the relevant ICO for additional information.
J. Internal Controls
The purpose of this manual issuance is to establish the NIH policy for managing NIH forms used within NIH.
- Review of Internal Controls. Through this manual issuance, the NIH Forms Officer is responsible for the method used to ensure that the internal controls are implemented and working;
- Frequency of Review: Ongoing;
- Method of Review: The NIH Forms Officer reviews NIH forms to ensure compliance with this policy;
- Review Reports: Are sent to the NIH Deputy Director for Management (DDM), Office of the Director (OD) upon request indicating that controls are in place and working well. They include any internal control issues that should be brought to the attention of the DDM.
- 21st Century Cures Act
- 21st Century Integrated Digital Experience Act
- Creating Advanced Streamlined Electronic Services for Constituents Act of 2019 ("CASES Act")
- HHS e-Gov Forms Policy
- NIH Manual 1743, Managing Federal Records
- OMB Circular No. A-108, Federal Agency Responsibilities for Review, Reporting, and Publication under the Privacy Act
- OMB Circular No. A-130, Managing Information as a Strategic Resource
- OMB/NARA M-19-21: Transition to Electronic Records
- OMB/NARA M-21-04 Modernizing Access to and Consent for Disclosure of Records Subject to the Privacy Act
- PSC Departmental Forms Management
- Section 508 of the Rehabilitation Act (29 U.S.C. § 794 (d)), as amended
- The Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.)
- The Plain Writing Act of 2010
- The Privacy Act of 1974 (5 U.S.C. 552a), as amended
- U.S. Web Design System (USWDS)
- NIH form - A NIH form is defined, for this chapter, as customized template document (i.e., not on-line information collection). An NIH form is designed for NIH operations and displays a forms control number issued under the NIH forms system. The NIH forms system generally excludes low-usage forms and forms used in limited areas for specific and limited use by an NIH Institute, Center, or Office (ICO). The NIH Forms Officer can help determine when a form number should be assigned. All forms created and used within NIH must meet federal accessibility and privacy standards. Most NIH forms will be NIH-wide forms, however, on specific occasions the form may be unique to a particular ICO (See B.2. above).
- Numbered Series of Forms - The following types of forms are used at NIH. Note that all forms are available electronically; when available, the website is provided:
- HHS Forms- Developed within the Department of Health and Human Services (HHS) and prescribed for general use throughout HHS. HHS forms are available at http://intranet.hhs.gov/forms/hhs_forms.html and http://www.hhs.gov/forms for HHS public-use forms.
- NIH Forms - Designed for NIH operations. An NIH form is produced when no other suitable form is available from higher sources. Sections E, G, and H of this chapter describe procedures and requirements for creating and revising NIH forms, and distributing, storing, and reordering forms. NIH forms are available from: https://oma.od.nih.gov/DMS/Pages/Forms-Management-All-Forms.aspx
- Optional Forms - Coordinated and numbered by the General Services Administration and are available for use on an optional basis to Government agencies. The prefix “OF” in the form number identifies Optional Forms. Optional Forms are available from: http://www.gsa.gov/forms/.
- Other Government Agency Forms - Developed and numbered by other Federal agencies, but available for use throughout Government. Some frequently used forms are available from: https://oma.od.nih.gov/DMS/Pages/Forms-Management.aspx.
- Standard Forms - Prescribed for mandatory use by Federal agencies. Standard Forms are approved and numbered by the General Services Administration. The prefix “SF” in the form number identifies Standard Forms. Please see the website: http://www.gsa.gov/forms/.
- Personally Identifiable Information (PII) – Information that can be used to distinguish or trace an individual’s identity, either alone or when combined with other information that is linked or linkable to a specific individual (See OMB Circular No. A-130).
- Privacy Act Record - Any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, his or her education, financial transactions, medical history, and criminal or employment history; which also contain his or her name, identifying number, symbol, or other identifying particular assigned to the individual, such as a fingerprint, voiceprint, or a photograph (5 U.S.C. 552a(a)(4)).
- Privacy Act System of Records - A group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular, assigned to the individual (5 U.S.C. 552a(a)(5)). A System of Records Notice is known as a SORN.
- Public Use Form (Information Collection Form) – This type of form is NOT covered by this policy. It requests standardized information from ten or more respondents (generally defined as non-government employees). Use requires advanced approval from the Office of Management and Budget (OMB) via the OMB clearance process. The approved form must have an OMB clearance number, expiration date, and burden statement clearly visible. The requirement includes, but is not limited to surveys, interviews, focus group guidelines, telephone screeners, questionnaires, and web-based questionnaires. See Appendix 2, below.
- Revised Form - An edition of a form with changes in format, text, or specifications, relative to the original or previous edition. Each NIH form shows a date of an issue next to the form number, usually in the bottom left corner, so that it is easy to distinguish between various editions of the same form.
Appendix - Checklist for Forms which come under Privacy Act Systems of Records
- Include on the form the unique number(s) of the Privacy Act system(s) of records in which the form will be used (for example: 09-25-0005). For a listing of NIH Privacy Act Systems of Records, go to the HHS website at https://www.hhs.gov/foia/privacy/sorns/index.html.
- Compare the information which will be recorded on the form with the descriptions in the notice of the system of records. Specifically, check that:
- The form will be filed only at places listed in the “System Location” section of the notice;
- The individuals on whom the information will be recorded on the form fall within the “Categories of Individuals Covered by the System” described in the notice;
- The information on the form falls within the “Categories of Records in the System” described in the notice;
- The intended use of the form within the agency is consistent with the “Purpose” section of the notice;
- Any intended use or disclosure of the form outside of HHS is authorized by a “Routine Use” specified in the system notice, or by one of the provisions in section (b) of the Privacy Act of 1974 (5 U.S.C. 552a), as amended;
- The physical medium in which the form will be maintained (e.g., paper, electronic) is listed in the “Policies and Practices for Storage of Records” section;
- The type(s) of individual identifiers (e.g., name, SSN) which will be used to retrieve the form are specifically included in the “Policies and Practices for Retrieval of Records” section of the notice;
- The form will be protected according to the “Administrative, Technical, and Physical Safeguards” section described in the notice;
- The form will be retained and disposed of by the authorized “Policies and Practices for Retention and Disposal of Records” section described in the notice;
- The notification and access official(s) identified in the notice will be able to locate forms about specific individuals, given the information specified in the “Notification Procedure” and “Record Access Procedure” sections; and,
- If any of these conditions are not met, either the form must be changed, or the system of records must be altered. The NIH Privacy Act Officer must authorize any alteration of the system of records.
- Provide a Privacy Act statement on the form itself, or as an attachment, for individuals who will be asked to provide information about themselves. The notification must state:
- Authority to collect information (i.e., statute or executive order) and whether the disclosure is voluntary or mandatory;
- The primary purpose(s) of information collection;
- Summary of routine uses for information disclosure;
- Effects on an individual (if any) of not providing all or any part of the requested information; and,
- Appropriate citation to the relevant SORN(s).
- Questions should be directed to the Privacy Coordinator within the NIH Institute, Center, or Office (ICO). For a list of NIH ICO points of contact, go to the OMA website at https://oma.od.nih.gov/DMS/Pages/Privacy-Program-Privacy-Coordinators.aspx.
Appendix 2 – Information Collection Not Covered by this Chapter
- This chapter does NOT cover forms designed for external NIH information collection, as this is NOT within the scope of the NIH Forms Management Program. Public use forms, used to collect public information, must carry an OMB clearance number, expiration date, and burden statement printed on the form in the format that OMB mandates.
If a form is being designed for this purpose, please consult the NIH Project Clearance Branch (PCB) in the Office of Policy for Extramural Research Administration (OPERA), Office of Extramural Research (OER), Office of the Director (OD), who serve as the control point for the OMB for all (intramural and extramural) outward facing information gathering, where a clearance process is required by the Paperwork Reduction Act to obtain approval of information collection forms targeted to 10 or more members of the public where the information is administrative in nature (meaning the analysis of the results will not be made public). PCB also acts as the liaison with other HHS components including the Office of the Secretary (OS) on public use forms and assists NIH offices with clearing public use forms with OMB. For information on obtaining OMB approval, contact the PCB, at 301-594-7949.
See also the OER Intranet site found at: https://extramural-intranet.nih.gov/policy-and-guidance/policy-topics/omb-clearance-requirements-for-surveys and MC 1825 - Information Collections from the Public.