Table of Contents:  

Section 1-1: Plan of the Manual

Section 1-1: Plan of the Manual

1-1-00 Policy
10 Procedures  
20 Information
30 Reporting Requirements

1-1-00 Policy

This section describes organization, maintenance, distribution and applicability of the NIH Design Requirements Manual (DRM).  This Manual supersedes all of the NIH Design Policy and Guidelines.  The NIH Design Requirements Manual is written in accordance with Section 3-4 “Design Guidelines” of Volume I of the HHS Facilities Program Manual.

A. Manual Organization
1. The Design Requirements Manual consists of chapters, which represent major subject categories.  The chapters are further broken down into sections, each of which shall set forth NIH design requirements and guidance with respect to NIH laboratory and vivarium design and rehabilitation. Exhibits/Appendices are included in the manual as necessary to disseminate examples, and additional detailed information.
2. The numbering system for manual chapters shall be as follows:

Chapter ……………..………... 1
Section ………………....……. 1-2
Sub-Section ................……… 1-2-10
Paragraph ………....……….. A
Subparagraph ….....………. A.1
Exhibit ………..............……. X1-2-A
Exhibit ………..............……. X1-2-B

The sections are generally organized in sub-sections as follows: Design Requirements, 1-1-00; Design Guidance, 1-1-10; Design Information, 1-1-20; and Design Document Requirements, 1-1-30. EXCEPTION to the format: In the case of design policies in Chapter 1 they are organized as follows: Policies, 1-1-00; Procedures, 1-1-10; Information, 1-1-20; and Reporting Requirements, 1-1-30.  

3. Exhibits to sections of this manual are numbered by placing an "X" before the section number and placing the exhibit letter immediately after the section number.  As an example, Exhibit B to Section 1-2 would be numbered Exhibit X1-2-B.

B. How to Use the Design Requirements Manual
The DRM is compiled for use by all divisions within the Office of Research Facilities Development and Operations (ORF) and the A/E’s designing laboratory and animal research facilities for NIH.  The DRM is organized by discipline. The Division of Technical Resources (DTR) may be contacted through the Project Officer for clarification of any particular requirement within the DRM. The appendices include code references, design resources, checklists, forms, and general information that will assist in developing complete designs. 

For ease of reference, portions of the DRM are interlinked within the body of the document.  Other helpful references provided throughout the DRM are hot linked to Web sites, including those found in the Appendices. The A/E shall contact the Project Officer for technical information requirements or coordination with the appropriate personnel within NIH for technical information required to complete a project.  

C. Maintenance
1. The Standards and Policy Branch (SPB), DTR, ORF is responsible for the maintenance of this manual.
2. Changes to the NIH Design Requirements Manual will be issued by the SPB.
3. Users of this manual are encouraged to submit proposed corrections, updates, and improvements to the Standards and Policy Branch for consideration.
4. It is the Policy Branch’s standard practice to solicit input on proposed changes from affected parties prior to publishing a change to the manual.

D. Distribution
1. The NIH Design Requirements Manual will be made available to each Office of Research Facility Development and Operation (ORF) Project Officer, Contracting Officer, and design contractor responsible for planning and design of NIH laboratories and vivariums.  Compliance with NIH design guidelines and requirements outlined in the manual is the responsibility of each NIH Contracting Officer, Project Officer and design contractor. Appropriate distribution to the design contractors shall be assured by the Contracting Officer. 
2. The manual will also be updated and posted on the ORF Web site

E. Effective Date
This manual is effective August 27, 2008.  Changes to the manual will be forwarded with an ORF Issuance Notice.  The date of the NIH Design Requirements Manual Issuance Notice shown at the top of each page of each chapter/section shall be the effective date of the change.

1-1-10 Procedures

A. Application
The NIH DRM establishes policy, design requirements and standards, and technical criteria for use in planning, programming, and designing of new NIH owned biomedical laboratories and animal research facilities and new additions to existing biomedical laboratories and animal research facilities.

B. Facility Acquisitions
Facility acquisitions include the purchase and/or lease of existing structures or facilities by the federal government.  For owned facilities, the A/E shall determine during early planning, what NIH life expectancy projections are for the particular facility and design to that expectation. Any proposed existing facility shall be evaluated prior to entering into a purchase or lease agreement for its capability to comply with the DRM. A determination shall be made for which elements of the DRM apply to the project based on the length of the lease.

C. Application of the DRM to Renovations
Application of the DRM to renovations shall be as required in the A/E contract.  A general conformance requirement in an A/E contract shall be interpreted as follows:

• Renovation that results in having an impact over 50% of the building area be in compliance with to the DRM.
• A full building gut renovation design shall be in complete conformance to the DRM.

D. Requirements by Reference: 
The appendices list reference documents that shall be used in conjunction with the DRM.  All A/E work prepared for NIH shall conform to all requirements and recommendations of the reference documents except where the written text of the DRM states otherwise.  For reference documents that are written as regulations, codes, or standards, all A/E work shall be in conformance as if the reference document were the written text of the DRM.  For reference documents that are written as handbooks, recommendations or manuals, the reference document shall be used as described in the DRM or where not described in the DRM, the ‘best practice’ methods recommended in the document shall be used.

1-1-20 Information

A. Guiding Principles from the HHS Facilities Program Manual as they relate to the NIH Design Requirements Manual
Investment decisions with regard to agency real property assets need to be integrated with and supportive of core mission activities to effectively manage and optimize real property assets.  To facilitate integrating real property asset management decisions with the agency mission requires two elements – a clear understanding of the agency’s mission that drives the allocation and use of all available resources (human capital, physical capital, financial capital and technology/information capital) and an effective decision making framework.  HHS facilities shall be planned and delivered to best meet the functional, safety, and environmental needs of the programs and missions they house.
• Environmental and Functional Needs: HHS buildings shall provide an environment in which occupants can perform their work with maximum efficiency at the optimum level of comfort.  Real Property Management decision making will support agency missions and strategic goals.  Appropriate levels of investment will be made in real property assets to advance customer satisfaction.
• Safety, Health and Security: HHS buildings shall provide an environment that is safe and healthy for occupants, and that, to the greatest extent possible, offers them maximum protection during emergencies or disasters.
• Economy: HHS facilities shall be planned and delivered at the most reasonable cost in terms of combined initial and long term expenditures, without compromising other mission requirements.  HHS will accurately inventory and describe all of its assets in order that full and appropriate utilization of space can be promoted.  Life cycle cost-benefit analysis shall be employed to explore alternatives for satisfying new requirements.  HHS will dispose of unneeded assets.
• Conservation and Resources: Energy and water conservation shall be given prime con-sideration in the planning and delivery of HHS facilities.  Products, materials, and systems shall be selected with a view toward maximizing the use of renewable resources.
• Preservation of historic and cultural resources shall be given full consideration in planning and delivery of HHS controlled real property assets and federally assisted undertakings.
• Sustainable Design: The planning, acquiring, siting, designing, building, operating and maintaining of HHS facilities shall take into consideration sustainable design principles including integrated design, energy performance, water conservation, indoor environmental quality and materials.

B. Compliance with Codes and Standards
In accordance with Section 3-4 of the HHS Facilities Program Manual and 40 U.S.C. 3312 each NIH building shall be constructed or altered, to the maximum extent feasible, in compliance with one of the nationally recognized model building codes and with other nationally recognized codes including mechanical and electrical codes, fire and life safety codes, and plumbing codes.  Due consideration shall be given to all State and local zoning laws as if the project were not being constructed or altered by a Federal agency.  The Government and its contractors shall not be liable for the cost of issuing local building permits or performing inspections for NIH construction.  The Contracting Officer shall insert a clause in every design and construction contract solicitation notifying prospective contractors of the statutory provisions of 40 U.S.C. 3112 (f) and (g).

The NIH main campus and headquarters is located in Bethesda, Maryland. The NIH has six field stations throughout the nation located in Poolesville, Maryland; Baltimore, Maryland; Hamilton, Montana; Research Triangle Park (RTP), North Carolina; Frederick, Maryland; and New Iberia, Louisiana.  Geographical requirements, local government mandates, and other unique design criteria are not specifically mentioned in DRM since the design shall abide by state and local regulations.  However, there are specific issues in a remote region that may be in conflict with the policies implemented by NIH in Bethesda, Maryland.  If this occurs, the more stringent policy shall apply except as mandated by the applicable authority. The A/E is required to check for site specific requirements, starting with the regional Project Officer and/or regional director for remote NIH sites.

Specific requirements at RTP that deviate from criteria in the DRM include but are not limited to:
• Authority Having Jurisdiction (AHJ) for Fire Protection.
• County permitting.
• Interface with DOHS/ORF.

Specific requirements at Rocky Mountain Laboratories (RML) that deviate from criteria in the DRM include but are not limited to:

• Special bracing design in 2B seismic zone designation.
• 100% standby power versus load shedding requirements.
• Special storm water management treatment due to gravel site.
• City mandated special manhole requirements.
• City mandated videotaping requirements.
• Unique traffic and noise standards.
• Historic Core.

C. Biosafety Levels
Laboratories involving research with biological materials are classified into four biosafety level (BSL) categories (BSL1, BSL2, BSL3, and BSL4).  These categories are outlined in detail in the Biosafety in Microbiological and Biomedical Laboratories (BMBL) issued by the CDC and NIH.   Animal research facilities house animals in an appropriate species specific environment that meets or exceeds all applicable policies, guidelines, and regulations as outlined in the Institute of Laboratory Animal Resources (ILAR) Guide for the Care and Use of Laboratory Animals (the “Guide”), BMBL, Public Health Service (PHS) policy, and Animal Welfare Regulations.  In addition, laboratories shall meet the minimum requirements to be accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC).  These facilities are classified into four animal biosafety level (ABSL) categories (ABSL1, ABSL2, ABSL3, and ABSL4). 

BSL3/ABSL3 is referred to as “containment” and BSL4/ABSL4 is referred to as “high containment” biomedical laboratory and animal research facilities.

All laboratory and vivarium practices in NIH facilities, at a minimum shall meet BSL2 requirements.  BMBL facility design requirements for laboratories operating at the BSL2 level require primary containment equipment such as BSCs autoclaves, bench top sink and pass through air. The ABSL2 animal facility requires autoclaves, hand washing sinks in the animal rooms and a mechanical cage washer.   Division of Occupational Health and Safety (DOHS) along with research program officials shall approve the decision to design for bio-safety levels higher than BSL2. 

Placing Fume Hoods and Biological Safety Cabinets in laboratories shall comply with the findings of the "Methodology for Optimization of Laboratory Hood Containment - Volumes I and II, November 1996, Farhad Memarzadeh, PhD, P.E., NIH – Office of the Director, ORF Publication, Bethesda, MD" 

1-1-30 Reporting Requirements
The DRM is a document that shall be used in Pre-Project Planning and reported and scored in the Project Definition Rating Index (PDRI) in accordance with Section 2-4 in Volume I of the HHS Facilities Program Manual.
(508 compliant)

This page was last updated on May 23, 2013