DHS coordinates the federal government’s overall response to or recovery from terrorist attacks. The Centers for Disease Control and Prevention (CDC) within the U.S. Department of Health and Human Services is the primary agency for the public health response to a biological terrorism attack or naturally occurring outbreak. The FBI within DOJ is the primary agency for the criminal investigation of incidents of bioterrorism. In its recommended guidelines for laboratories engaged in microbial forensic analyses, the Scientific Working Group on Microbial Genetics and Forensics (SWGMGF) defines attribution as “the information obtained regarding the identification or source of a material to the degree that it can be ascertained.” As part of the effort to deter biological terrorism and strengthen the law enforcement response to such an act, Homeland Security Presidential Directive (HSPD) 10, “Biodefense for the 21st Century” established within DHS a dedicated central microbial forensic laboratory known as the NBFAC to provide bioforensics analysis of evidence associated with the event. This Presidential Directive established the NBFAC as “the lead federal facility to conduct and facilitate technical forensic analysis and interpretation of materials recovered from biocrime and bioterror investigations in support of the appropriate lead federal agency.” DHS Science and Technology (S&T) is to accelerate the delivery of enhanced technological capabilities to meet the requirements and fill capability gaps to support DHS agencies in accomplishing their mission. Pursuant to this mission the DHS Chemical and Biological Defense (CBD) Division seeks technologies to defend against a chemical and biological attack. In addition, the division is charged with pursuing research to improve response and restoration, conduct threat risk assessments, and invest in bioforensics R&D. In this regard, the Bioforensics R&D Program, according to DHS, supports NBFAC operational threat agent identification and characterization through investments in bioforensics research and next generation technologies to include molecular biology, genomic comparison techniques, genotyping assays and physical and chemical analysis of sample matrix to better understand the origin, evolutionary history, production method and dissemination mechanism associated with the malicious use of biological agents. Bioforensics has been defined as an interdisciplinary field of microbiology devoted to the development, evaluation, validation, and application of methods to detect and fully characterize microbial samples containing a biological agent or its components for the purpose of making statistically meaningful comparative analyses. Attributing something to a perpetrator requires different types of information and analysis—both traditional and bioforensics. Information produced by forensic examination can result in an investigative lead or provide support for the investigation. Bioforensics capabilities used to provide analyses of evidence may show how, when, and where microorganisms were grown and potential methods for dissemination, which assists attribution. Bioforensics evidence could include the agent that was released, toxins, nucleic acids, and protein signatures. It could also include contaminants, additives, and evidence of preparation methods. Traditional evidence could include fingerprints, hair, fibers, documents, photos, firearms, and body fluids. In a bioforensics case, the intent would likely be to gather sufficient information to allow a comparison of an evidentiary sample with a known reference sample to assist in supporting source attribution. Evidence from a bioforensics investigation must also meet the scientific community’s standards for evidence as well as a criminal court’s standards for legal admissibility. DHS has developed strategic plans and goals related to bioforensics attribution and identified some key bioforensics capability needs. However, according to DHS officials, DHS did not perform a bioforensics capability gap analysis, but, rather, used an informal approach to identify capability needs and gaps. DHS officials stated that they did not document the process DHS used or the results of its informal approach. Further, DHS officials told us that there is not a complete list of the gaps identified using the informal approach. Finally, although they indicated that DHS had focused resources toward addressing those gaps, they could not provide documentation of the bioforensics capability requirements and other relevant information to support the capability gap identification and resource allocation decisions that were made. In the absence of documentation of the processes, discussions, analyses, decisions, or any other activities performed to identify and prioritize bioforensics gaps, DHS’s rationale for the identification and prioritization of needs and gaps on which to focus its resources is unclear. According to DHS officials, DHS relies on the DHS S&T-managed NBFAC and bioforensics R&D programs to identify bioforensics capability needs and gaps. However, DHS does not have a complete list of its bioforensics capability gaps because it has not performed a bioforensics capability gap analysis. According to the DHS Systems Engineering Life Cycle guide, a gap analysis is a best practice that is essential to understanding whether capabilities exist that can meet requirements, or if they must be developed. In addition, some DHS officials told us that performing a capability gap analysis is a best practice that DHS programs should follow, even in the absence of DHS guidance to do so. In interviews and written responses, DHS officials described generally how DHS identified and documented capability needs and gaps. They told us that they identify priorities each fiscal year, develop projects to meet these priorities, and develop the NBFAC Annual Plan to address these priorities. However, they told us that there is no documentation of the process or results of the informal approach they used to identify bioforensics capability needs and gaps. According to federal standards for internal control, documentation is necessary for the effective design, implementation, and operation of an entity’s internal control system. Lacking documentation of the processes, discussions, analyses, decisions, or any other activities performed to identify and prioritize capability gaps, it is unclear what DHS’s rationale was for the identification and prioritization of bioforensics capability needs and gaps. Identifying and prioritizing capability gaps enables the proper allocation of resources to the highest priority needs. Thus, without a capability gap analysis, DHS may not have identified and prioritized all capability needs and gaps, and so may not be allocating resources to address the most significant gaps to meet its mission needs. DHS officials told us that no complete list of bioforensics capability gaps has been created since 2010. However, they told us that DHS had developed a document from 2013-2014—the Bioforensics Roadmap (Roadmap)—as a means to identify and achieve consensus from stakeholders on the key bioforensics capability needs on which to focus DHS resources. DHS officials said that the Roadmap lays out the Bioforensics R&D Program execution and also lists the key needs on which DHS has focused, or will focus, resources, along with the associated programs to address the needs. DHS developed strategic plans for its National Biodefense Analysis and Countermeasures Center (NBACC) in 2012 and Chemical and Biological Defense in 2013. It documented NBFAC strategic goals in 2013. These documents include strategic objectives related to bioforensics that could be used to guide a capability gap analysis. A former DHS official who had participated in DHS’s process for the identification of bioforensics gaps told us that the process was informal and also that there is no documentation of the process. This official summarized it as generating a list of topics and issuing BAAs to address them. Other DHS officials confirmed that the process was informal and that there was no documentation of the results. They told us that they are unaware of the details of the processes and activities performed to identify capability needs and gaps. However, they did describe generally the informal process that DHS used. They indicated that the process included working with key interagency partners and other stakeholders—such as the FBI—and engaging in discussions, exchanging emails, and holding periodic meetings. DHS officials also stated that they met informally as needed with the FBI and some intelligence agencies to discuss needs and gaps. These officials explained that the discussions with DHS’ interagency partners were part of a larger process to develop and manage NBFAC and bioforensics R&D programs. They said that DHS coordinated with the FBI and the Intelligence Community to focus these programs’ activities to meet the needs of these end users. Further, they said that the Roadmap was vetted by other agencies and researchers. In addition, according to FBI officials, the FBI conducted assessments of its capabilities by working with the DHS S&T and providing direction to DHS about its capability needs. FBI officials stated that sometimes the FBI does not know there is a bioforensics capability gap until it encounters one during an investigation. Independent assessments of DHS’s S&T Bioforensic R&D program have raised similar concerns about how DHS has identified and prioritized bioforensics capability gaps. For example, external assessments of the CBD portfolio from 2012 and 2014 found a lack of clarity about how the Bioforensics R&D program identified and prioritized capability gaps and why some projects were chosen. The reviewers recommended that the program manager describe the program’s basis for identifying capability gaps and selecting projects in future reviews. Specifically, a November 2014 review acknowledged the need for enhancing bioforensics capabilities but questioned the lack of information on how gaps in capability or knowledge guiding R&D investments were identified and prioritized. A 2012 review stated that it was unclear why some research studies were chosen over others, as well as how the selection of projects was linked to, or justified against, the risk assessment. Through the Roadmap, key bioforensics efforts have been identified, which DHS officials characterized as gaps. The efforts listed in the Roadmap include (1) operational infrastructure, (2) sample collection and preservation, (3) sample extraction, (4) identification and characterization, and (5) data analysis and integration. The Roadmap also includes existing and future CBD and other agency programs, as well as commercial development, linking them to the particular capability gap they address.