Department of Health and Human Services (HHS) Fiscal Year 2020 Agency Report

1. Please provide a summary of your agency’s activities undertaken to carry out the provisions of 

OMB Circular A-119, “Federal Participation in the Development and Use of Voluntary Consensus 

Standards and in Conformity Assessment Activities” and the National Technology Transfer and 

Advance Act (NTTAA). The summary should contain a link to the agency’s standards-specific 

website(s) where information about your agency’s standards and conformity assessment related 

activities are available.

1. Agency for Healthcare Research and Quality (AHRQ)

The mission of AHRQ is to produce evidence to make health care safer, higher quality, more accessible, 

equitable, and affordable, and to work within the U.S. Department of Health and Human Services and 

with other partners to make sure that the evidence is understood and used. AHRQ uses voluntary 

consensus standards in our national Medical Expenditure Panel Survey, in our Healthcare Costs and 

Utilization Project, in our Quality Indicators, and in AHRQ’s United States Health Information 

Knowledgebase. AHRQ supports the U.S. standards developing organizations (SDOs) through 

participation in relevant workgroups. By improving the uniformity, accuracy, validity and digitization of 

health data used for research and decision making, AHRQ increases the robustness of its research 

findings and the usability of tools developed based on these findings.

2. Centers for Disease Control and Prevention (CDC)

Center for Surveillance, Epidemiology, and Laboratory Services (CSELS)

CDC Centers, Divisions, and Programs work with partners in a voluntary and consensus manner to 

develop, evaluate, and apply standards for data capture and dissemination. Below is a summary of 

significant standards for communications, messaging, data structuring and transport. CDC endeavors to 

follow industry or community agreed upon standards with subtle content level modifications to 

accommodate the complex and varied demands of public health whenever possible. During the 

development process, CDC works with local public health departments, academia, non-profits, and 

healthcare industry and information technology partners to collaboratively achieve consensus.

Type / Domain Document Transaction Standard(s) Used Status

Communications and Directory HL7 CDA ® Release 2 Implementation Guide: Reporting to Public Health 

Cancer Registries from Ambulatory Healthcare Providers, Release 1, DSTU Release 1.1 – US

Cancer Reporting

(Stage 3 MU) HL7 CDA Published

Communications and Directory Implementation Guide for Ambulatory Healthcare Provider Reporting to 

Central Cancer Registries (March 2014)

Cancer Reporting

(Stage 2 MU) HL7 CDA Published
Communications and Directory Implementation Guide for Ambulatory Healthcare Provider Reporting to 

Central Cancer Registries (August 2012)

Cancer Reporting

(Stage 2 MU) HL7 CDA Published

Communications and Directory PHIN Communication and Alerting (PCA) Guide Version 1.3 (April 27, 

2010) Public Health Alerting EDXL V 1.0

CAP V1.1 Published

Communications and Directory PHIN Directory Exchange Implementation Guide Version 1.0 (May 16, 

2007)

Public Health Directory Exchange DSML 1.0 Published

ELR HL7 Version 2.5.1 Implementation Guide:Electronic Laboratory Reporting to Public Health (US 

Realm), Release 2, HL7 Informative Document (May 2014)

(HL7 account required) Electronic Laboratory Reporting to Public Health HL7 2.5.1 Published

NNDSS https://wwwn.cdc.gov/nndss/case-notification/message-mapping-guides.html

Specific Notifiable Disease Reporting to Public Health (Final Guides) HL7 2.5.1 Published

Syndromic Surveillance (HL7 Standard for Trial Use) Syndromic Surveillance Message Mapping Guides

Syndromic surveillance transmissions from healthcare providers to public health HL7 Version 2.5.1,

ICD-10-CM,

SNOMED-CT,

LOINC,

Rx Norm,

UCUM,

CPT4 HL7 Standard for Trial Use v.1. Available on the HL7 website (membership required.

Syndromic Surveillance PHIN Messaging Guide for Syndromic Surveillance: Emergency Department, 

Urgent Care, Inpatient and Ambulatory Care Settings, Release 2.0 (April, 2015)

Erratum to the PHIN Messaging Guide for Syndromic Surveillance: Emergency Department, Urgent Care, 

Inpatient and Ambulatory Care Settings ADT Messages A01, A03, A04 and A08 Optional ORU^R01 

Message Notation for Laboratory Data HL7 Version 2.5.1 (Version 2.3.1 Compatible) Release 2.0 April 21, 

2015pdf icon

PHIN 2.0 Implementation Guide Meaningful Use Clarifying Document (PDF available on NIST 

Website)external icon

Sending data from emergency department, urgent, ambulatory care and inpatient settings to public 

health authorities

Certifying 2014 Edition Meaningful Use electronic health record technology HL7 2.5.1

Published as CDC version 2.0

Center for State, Tribal, Local, and Territorial Support (CSTLTS)

The Centers for Disease Control and Prevention (CDC) Center for State, Tribal, Local, and Territorial 

Support (CSTLTS) has been a key supporter in the development, launch and support of the voluntary 
accreditation program for public health departments. A non-profit accrediting body, the Public Health 

Accreditation Board (PHAB), was established to lead the accreditation program which launched in 

September 2011. CDC has been involved as a partner and co-funder (with the Robert Wood Johnson 

Foundation) of this initiative. As part of this effort, PHAB engaged hundreds of public health 

practitioners in developing and testing all elements of the program, including the standards and 

accreditation assessment process. The PHAB standards and assessment process meet the definitions of 

OMB Circular A-119, regarding voluntary consensus standards and conformity assessment processes.

Until the establishment of PHAB, there had been no national accreditation program for public health 

departments. The program is intended to “improve and protect the health of the public by advancing 

the quality and performance of public health departments.”. The first cohorts of health departments 

were accredited in early 2013. As of the end of FY 2020:

• PHAB has accredited 361 health departments—36 states, four tribes, and 331 local health 

departments (including 264

individually accredited local health departments and 67 county health departments through a 

centralized state application

• 82% of the U.S. population is served by an accredited health department (HD).

• PHAB began reaccrediting sites in 2018; 32 sites have been reaccredited.

• 510 HDs, including 41 SHDs, are formally in the accreditation process (applied or accredited) and are 

demonstrating how they meet the national standards.

All documents related to the accreditation program (the standards, assessment process guidance, 

glossary, etc.) are available at www.phaboard.org. The initial national consensus standards were 

released in July 2011 (Version 1.0) and an update (Version 1.5) was released in 2014. CDC participated in 

PHAB efforts to support requirements for reaccreditation, published manuscripts about its support of 

accreditation in a journal, and has been collaborating to explore a variety of topics that can inform the 

Version 2.0 updates to the Standards and Measures, which are planned for release in 2022. CDC’s 

interest and support regarding this accreditation program is evidenced through its accreditation page at 

http://www.cdc.gov/stltpublichealth/accreditation/.

Evaluation data to date show very positive findings about benefits and impact. A PHAB survey in July 

2020 found that more than 80% of accredited health departments indicated that, overall, accreditation 

has helped their response to the COVID-19 pandemic. Annual evaluation findings also consistently 

report benefits to participating in accreditation. April 2020 evaluation data indicate that the program 

has stimulated quality improvement (96% of accredited health departments agree), improved 

accountability (80%), improved the capacity of the department to provide high quality programs and 

services (82%), and strengthened the utilization of resources (71%). More information about the positive 

impact of the accreditation program can be found by reviewing data and reports available through 

PHAB’s website and in May/June 2018, an issue of the Journal of Public Health Practice and 

Management was dedicated to the Impact of Accreditation and included several manuscripts authored 

by federal partners. Evaluation findings are also summarized through this Morbidity and Mortality 

Weekly Report (MMWR) manuscript, which was co-authored by PHAB and CDC: 

(https://www.cdc.gov/mmwr/volumes/65/wr/mm6531a3.htm?s_cid=mm6531a3_e)

Division of Cancer Prevention and Control (DCPC)
CDC’s National Program of Cancer Registries (NPCR) works to measure progress in preventing and 

treating cancer, a leading cause of death in the United States. Established by Congress through the 

Cancer Registries Amendment in 1992, NPCR collects data on cancer occurrence (including the type, 

extent, and location of the cancer), the type of initial treatment, and outcomes. Today, through NPCR, 

CDC supports central cancer registries in 46 states, the District of Columbia, Puerto Rico, the U.S. Pacific 

Island Jurisdictions, and the U.S. Virgin Islands. These data represent 97% of the U.S. population.

NPCR follows the data collection and quality standards in the North American Association of Central 

Cancer Registries (NAACCR) consensus documents. Annually, these data are evaluated for quality, 

completeness, and timeliness according to the National Data Quality Standard for 23-month data and 

the Advanced National Data Quality Standard for 12-month data. Data also are evaluated according to 

the USCS Publication Standard before publication. NPCR standards can be found here.

National Center for Health Statistics (NCHS)

The National Center for Health Statistics (NCHS) Classifications and Public Health Data Standards Staff 

(CPHDSS) continues to serve as the focal point for assessing and supporting a wide array of public health 

data standards and standards development activities to support the mission of NCHS. CPHDSS 

participates in health data standards activities to provide public health representation in the

development, maintenance and implementation of national healthcare standards to meet the needs of 

population health that supports vital records reporting and specific survey data requirements for NCHS 

data systems. NCHS has had successful outcomes over the past year in its standards activities including: 

development of an Implementation Guide for use by Jurisdictions and their Health IT system vendors 

that will support the reporting of natality using a new specification based on emerging industry 

approaches, but informed by years of lessons around requirements, successes and challenges gained 

through defining and implementing historically mature standards. Additionally, the National Health Care 

Surveys have continued to progress their standards development to fulfill the reporting requirements 

for the public health objectives under Promoting Interoperability (PI) regulations; and, the development, 

enhancement and expansion of standards for reporting and interoperability.

Details of activities and reports about the Center’s eVital Standards Initiative are available within the 

newly established Vital Statistics Modernization Community of Practice (CoP): 

https://www.cdc.gov/nchs/nvss/modernization/cop.htm. A complete list of eVital standards is available 

at http://www.cdc.gov/nchs/nvss/evital_standards_intiatives.htm. Under this initiative, CDC/NCHS is 

working with the National Association for Public Health Statistics and Information Systems (NAPHSIS), 

state representatives and other vital records stakeholders to develop vital records standards to enable 

electronic data exchanges among electronic health record systems, U.S. vital records systems and 

potentially other public information systems for birth, death and fetal death events. NCHS also provides 

support for state pilot testing and trial implementation to promote the refinement and adoption of eVital Standards-based interoperability. Information on accessing the national standards for vital records 

reporting is available at https://www.cdc.gov/nchs/nvss/evital/accessing_evital_standards.htm. 

Additional informational products including presentations, posters and papers are readily accessible to 

interested stakeholders.
NCHS is engaged in the development and use of the new Health Level 7 International (HL7) Fast 

Healthcare Interoperability Resources (FHIR) standard. This work aims to leverage the latest web 

standards and focuses on implementation to improve the timeliness of mortality and natality reporting 

as well as the initial development and use of FHIR with Health Care Surveys. NCHS is also working with 

our state vital records agencies through the NVSS Community of Practice to explore how national 

standards can be utilized for the Center to provide coded cause of death and race and ethnicity 

information in response to states’ death reporting information. These standards for both mortality and 

natality were tested with state vital records offices and their electronic death and birth registration 

system vendors at HL7 FHIR Connect-a-thons. Regarding the National Health Care Surveys (NHCS), in 

2020 NCHS participated as a use case for a FHIR reference architecture known as Making EHR Data More 

Available for Research and Public Health that Reference Architecture (MedMorph). It refers to a 

common framework (e.g., FHIR resources, FHIR APIs, FHIR operations, security mechanisms) that will be 

leveraged by multiple public health and research use cases. Health Care Surveys is a specific use case 

within this framework and will have FHIR profiles developed for survey reporting. These efforts support 

the interoperability among various public health systems and Health IT systems.

Efforts have continued the development of an HL7 FHIR implementation guides for vital records 

management and reporting. In April 2020, the HL7 Birth and Fetal Death FHIR implementation guide was 

drafted with the support and feedback of a workgroup consisting of state vital records representatives, 

electronic birth registration system vendors and natality subject matter experts. This effort was to 

prepare a ballot for publication during the HL7 January 2021 ballot cycle. In October 2020 the HL7 Vital 

Records Death Reporting FHIR implementation guide was published as a standard for trial use. Ongoing 

maintenance and development for this standard has continued throughout 2020. Additionally, 

maintenance has continued for the development of the HL7 V2.6 and Integrating the Healthcare 

Enterprise (IHE) standard for vital records. The HL7 VR messaging and document standards and the IHE 

VR standards have been enhanced to support interoperability for the complete flow of information from 

the provider to the jurisdiction, and bi-directional reporting of death events between the jurisdiction 

and NCHS including mortality coding as well as race and ethnicity coding. These standards support 

implementers whose legacy systems are still using these specific versions of standards and may have the 

ability to transform between various standards. For example, some systems may transform V2 to FHIR 

when transporting data among disparate systems. It is for these reasons the maintenance of other 

standards is paramount. These various types of standards within the standards developing community 

provide the foundation to support new emerging standards such as FHIR. The legacy standards 

development NCHS has participated in during previous years has provided the groundwork for 

efficiently creating other standards.

In addition to FHIR standards and architecture involvement, the Division of Health Care Statistics at 

NCHS is transitioning from data collection by medical record abstraction to accepting electronic 

submission of clinical data from health care provider’s electronic health records (EHRs). To support this 

effort, in 2020 NCHS developed an updated HL7 Consolidated Clinical Document Architecture (CDA) 

implementation guide, which is expected to be released in 2021. This HL7 CDA National Health Care 

Surveys implementation guide includes Release 1.2 and 3 and is intended initially to be the national 

electronic standard for the implementation of the meaningful use and promoting interoperability (PI) 

objective for specialized reporting to NCHS. Implementers of this IG will be able to submit data to fulfill 
the requirements of the surveys by automatic extraction of the data from the providers’ EHR or data 

repository. Information on these standards is available on 

http://www.cdc.gov/ehrmeaningfuluse/national_health_care_surveys.html.

In 2020 communication and outreach efforts were initiated to get Health Care Survey reporting into 

Health IT vendor’s Real World Testing plans as mentioned within the Office of the National Coordinator 

for Heath Information Technology (ONC) regulations: https://www.healthit.gov/condition-ccg/realworld-testing

NCHS continues to provide support for the development, maintenance and expansion for various 

standards and their content profiles and has expanded into the reference architecture realm to better 

support the transactions among external disparate systems. These standards provide a mechanism to 

utilize information obtained from health IT systems for public health reporting.

National Institute for Occupational Safety and Health (NIOSH)

The National Institute for Occupational Safety and Health (NIOSH) encourages its employees with 

relevant expertise to participate as approved representatives in the development of national and 

international standards activities as part of voluntary consensus standards committees. NIOSH currently 

has 51 staff contributing their expertise to approximately 22 major committee organizations (e.g., ANSI, 

ISO, ASTM, NFPA). Participation by NIOSH staff on such committees affords the Institute an opportunity 

to ensure standards are established using sound evidence-based science, as well as to help facilitate the 

transfer of NIOSH research findings into improved occupationally-related health and safety practices, 

procedures, and policies. A list of NIOSH-approved participation in established voluntary consensus 

standards committees can be found at: http://od.niosh.cdc.gov/Consensus-Standards/ConsensusStandards.html.

3. Centers for Medicare and Medicaid Services (CMS)

The National Standards Group (NSG) within the Office of Burden Reduction & Health Informatics at the 

Centers for Medicare & Medicaid Services (CMS) is responsible for identifying and adopting national 

standards and operating rules to increase the electronic exchange of health information between 

covered entities. Covered entities include all health plans, certain health care providers and health care 

clearinghouses, and these organizations are defined in the Health Insurance Portability and 

Accountability Act of 1996 (HIPAA). Representatives from NSG participate with several national 

standards development organizations as they develop and/or update the standards and operating rules 

in preparation for the next version to be considered for adoption. NSG is committed to encouraging 

adoption of electronic standards by all covered entities, including those organizations in the private and 

public sector, as electronic transaction standards will increase efficiency in health care.

NSG staff participate in workgroups of the standards setting organizations listed below. The specific 

transactions (for business operations) developed by these organizations include enrollment, eligibility,

claims, claim status, electronic funds transfer, remittance advice, prior authorization, and attachments:
1) Health Level 7 (HL7): www.HL7.org

2) National Council for Prescription Drug Programs (NCPDP): www.ncpdp.org

3) Accredited Standards Organization, Insurance (X12N): www.x12.org

4) Council for Affordable Quality Healthcare (CAQH) Committee for Operating Rules for Information 

Exchange (CORE) CAQH

CORE: www.caqh.org

5) NACHA (the Electronic Payments Association): www.nacha.org

6) The Designated Standards Maintenance Organization (DSMO): www.hipaa-DSMO.org

NSG also monitors the activities of NIST, and the Office of the National Coordinator. This year, NSG 

collaborated with the Office of the National Coordinator to post the administrative transaction 

standards on the Interoperability Standards Advisory. This gives greater visibility to the voluntary 

consensus standards developed by the SDOs. View the advisory here: https://www.healthit.gov/isa/.

The Quality Measurement and Value-Based Incentives Group (QMVIG) in the Centers for Clinical 

Standards and Quality (CCSQ) at CMS also selects and implements performance measures for healthcare 

provider quality reporting, public reporting, and value-based purchasing programs. CMS prefers to use 

quality measures that have gone through a consensus endorsement process and can be considered 

consensus-based standards. The National Quality Forum (NQF), a not-for-profit private sector 

organization, meets the NTTAA definition of a consensus-based organization, is currently contracted by 

CMS to perform a transparent consensus development process to endorse performance measures. The 

process includes: a comprehensive open call for measures; review of scientific and statistical evidence; 

review and discussion by a balanced panel of external experts and stakeholders; opportunities for public 

and expert comment and feedback; and an appeals process for stakeholder objections. NQF’s processes 

are consistent with the NTTAA and OMB Circular A-119.

1) CMS Quality Measures: http://www.cms.gov/QualityMeasures/

2) National Quality Forum: http://www.qualityforum.org/

4. Food and Drug Administration (FDA)

FDA is responsible for advancing public health by helping to bring safe and effective medical products 

and foods to the U.S. public; and helping the public get the accurate, science-based information they 

need to use medicines and foods to improve and maintain their health. Standards help to ensure data 

and process consistency and enable use of advanced technology and analytics in FDA’s performance of 

its mission. Where feasible, FDA participates in the development of, and uses voluntary consensus 

standards (VCS) to help facilitate consistent and predictable product manufacturing and assessment, 

regulatory testing, clinical trial data exchange, and product labeling, just to name a few examples. 

Information exchange with our stakeholders promotes efficiency and awareness in the standards setting 

processes. The Agency looks for the appropriate time, process, and forum by which we can engage with 

standard setting organizations. By doing so, FDA can facilitate standard setting activities and not hinder 

or duplicate efforts that are already underway in complementary bilateral or multilateral discussions. 

The use of voluntary consensus standards can increase predictability, streamline premarket review, and 

facilitate market entry for safe and effective products, including products of emerging technologies, 
under FDA regulatory authority.

In addition, FDA participates actively in the standard setting process of the Codex Alimentarius, which 

for over 50 years has provided governments with a venue for adoption of food standards to facilitate 

safety and fair-trade practices. Codex is a joint body of the Food and Agricultural Organization of the 

United Nations and of the World Health Organization, and the standards developed through this body 

are recognized by the World Trade Organization. FDA supports Codex through the participation of 

experts and delegates representing the United States and through hosting meetings, along with the (The 

U.S. Department of Agriculture’s (USDA) USDA Food Safety and Inspection Service. While FDA is not 

obligated to adopt the standards, Codex provides greater assurances of the safety of food imports, as 

many countries that export to the United States will adopt Codex standards.

Standards developed through interactions with various standard development bodies, including VCS 

organizations and/ or industry consortia, can provide benefit to both the Agency and our stakeholders in

multiple ways such as:

• Standards can assist reviewers with assessment of products and product applications;

• Standards often result in better utilization of limited internal resources;

• International standards can be used by multiple regulatory regions that can facilitate global 

harmonization, to the extent feasible;

• Direct participation by a broad group of stakeholders in development of standards can result in 

consensus among users, practitioners, manufacturers, and government regulators on safety and 

effective use of regulated products;

• Reduction in the costs and in transcription errors resulting from manual data entry such as for 

registrations and listing and adverse event reporting; and

• Reduction in the cost for incorporating new electronic processes such as electronic food and device 

labeling by leveraging existing exchange standards, business processes and information technology (IT) 

systems.

FDA policy is to help develop and use voluntary consensus standards wherever possible in the 

management of products FDA regulates. FDA supports the letter and spirit of the National Technology 

Transfer and Advancement Act (NTTAA) and the Office of Management and Budget (OMB) Directive. For 

more information about FDA’s policies and procedures related to standards management, please see 

our Staff Manual Guide 9100.1 at: 

http://www.fda.gov/AboutFDA/ReportsManualsForms/StaffManualGuides/ucm193332.htm

For more information about FDA data standards and the FDA Data Standards Council, please see: 

http://www.fda.gov/ForIndustry/DataStandards/default.htm

Center for Devices and Radiological Health (CDRH)

CDRH gained authority under the 21st Century Cures Act to enhance its Standards Recognition Program. 

A final guidance titled Recognition and Withdrawal of Voluntary Consensus Standards published on 

September 15, 2020 notes that FDA will publish its rationales about recognition decisions, respond to 
recognition requests within 60 days and establish transition times to revised recognized standards 

(when appropriate). Finally, the guidance reflects FDA’s commitment to periodically update the 

Recognized Standards Database with pending recognitions. This means that once FDA decides to 

recognize a standard and it will appear in the standards recognition database. Manufacturers may cite it 

in premarket submissions and will no longer need to wait for the publication of a Federal Register 

notice.

During FY2020, in accordance with section 514(c), 21 U.S.C. 360d(c), FDA/CDRH published the following 

notices to the Federal Register to announce the addition, withdrawal, correction, and/or revision of 

certain consensus standards the Agency will recognize for use towards a declaration of conformity in 

premarket submissions and other requirements for medical devices:

Publications in the Federal Register related to Modifications to the List of Recognized Standards is 

available at 

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm

Standards recognitions published during FY 2020:

Date Federal Register Notice

March 30, 2020 FR Notice (List #53) [Docket No. FDA-2004-N-0451]

https://www.govinfo.gov/content/pkg/FR-2020-03-30/pdf/2020-06520.pdf

October 24, 2019 FR Notice (List #52) [Docket No. FDA-2004-N-0451]

https://www.fda.gov/media/131993/download

Access to the current FDA List of Recognized Consensus Standards, as published and updated in the 

Federal Register, can be found at 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm

Conformity Assessment

In general, conformity assessment activities for FDA-regulated products are conducted under applicable 

regulations and guidance that are informed by our standards development efforts described above. 

Standards may become part of conformance activities as they may provide an acceptable approach to 

ensure compliance with applicable laws and regulations.

CDRH’s Standards and Conformity Assessment Program (S-CAP) has launched a voluntary pilot called the 

‘Accreditation Scheme for Conformity Assessment,’ or ASCA. Conceptualized to promote a least 

burdensome approach to medical device review, ASCA was developed in conjunction with the device 

manufacturing industry, standards development organizations and conformity assessment entities. The 

ASCA Pilot relies upon international consensus standards (ISO/IEC 17011 and ISO/IEC 17025) augmented 

by additional ASCA specifications and is designed to increase FDA’s confidence in testing methods and 

results from ASCA-accredited testing laboratories. Ultimately the ASCA Pilot is expected to make device 

review more efficient, ensuring patients have access to safe and effective medical devices without 

unnecessary delay. The final guidances outlining program specifications can be found on the ASCA Pilot 

web page and listed below:
• ASCA Pilot program guidance: The Accreditation Scheme for Conformity Assessment (ASCA) Pilot 

Program - Final Guidance

• Basic Safety and Essential Performance standards-specific guidance: Basic Safety and Essential 

Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical 

Equipment - Standards Specific Information for the Accreditation Scheme for Conformity Assessment 

(ASCA) Pilot Program

• Biocompatibility standards-specific guidance: Biocompatibility Testing of Medical Devices- Standards 

Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program

The docket number: for these guidances are under docket FDA-2019-D-3805.

Center for Food Safety and Applied Nutrition (CFSAN)

The FDA Food Safety Modernization Act (FSMA) gives the Agency explicit authority to establish a 

program for accreditation of conformity assessment bodies (identified in the statute as third-party 

auditors) to conduct food safety audits and to issue certifications for FDA-regulated food, which includes 

human food, pet food, and non-medicated animal feed. FSMA established the “Accreditation of ThirdParty Certification Bodies to Conduct Food Safety Audits and to Issue Certifications,” program at 21 CFR 

part 1 subpart M. The regulation describes the framework, procedures and requirements for 

accreditation bodies seeking recognition by the FDA, as well as requirements for third-party certification 

bodies seeking accreditation under the program. Accreditation bodies and third-party certification 

bodies may use documentation of their conformance with ISO/IEC 17011:2004, ISO/IEC 17021:2011, and 

ISO/IEC 17065:2012 in meeting the requirements of the regulation, supplemented as necessary (e.g., to 

meet the conflict of interest, reporting, and notification standards in section 808 of the FD&C Act). FDA 

recommendations on third-party certification body qualifications for accreditation to conduct food 

safety audits and to issue food and/or facility certifications under the voluntary third-party certification

program are contained in a guidance document entitled, “Third-Party Certification Body Accreditation 

for Food Safety Audits: Model Accreditation Standards” (link to guidance here)

As part of these recommendations, FDA cited ISO/IEC 17021:2011 and ISO/IEC 17065:2012, which are 

voluntary consensus standards on accreditation that are widely used in determining the qualifications of 

third-party conformity assessment bodies that audit and certify the food industry. As of the end of FY20, 

the FDA has recognized 4 accreditation bodies which have accredited 8 certification bodies. A registry of 

recognized accreditation bodies and accredited certification bodies is available on the Accredited Thirdparty Certification Program webpage (link to page here).

FSMA also gives us express authority to establish a laboratory accreditation program for the analyses of 

foods. FDA issued a proposed rule in November 2019 that would implement this program (link to 

proposed rule here). The proposed rule would establish the oversight, uniformity, and standards 

necessary to help ensure that the results of certain food testing of importance to public health are 

reliable and accurate. As proposed, FDA would recognize accreditation bodies that would then accredit 

laboratories to conduct food testing. The proposed rule would incorporate by reference two voluntary 

consensus standards: ISO/IEC 17011:2017 would form the foundational requirement for accreditation 

bodies, and ISO/IEC 17025:2017 would form the foundational requirement for food testing laboratories. 
The comment period closed in July 2020; FDA expects to issue a final rule establishing this program in 

early 2022.

FDA’s Moffett Proficiency Testing Laboratory (Moffett PT), located within CFSAN’s Office of Food Safety, 

Division of Food Processing Science and Technology and part of the Institute for Food Safety and Health, 

has been an ISO/IEC 17043 accredited proficiency testing provider since February 2017 but has been in 

operation within FDA in varying capacities since the 1950s. This PT program’s scope of work is expansive 

as it is the official PT provider for FDA’s inter-/intra-agency programs (CVM Veterinary Laboratory 

Investigation and Response Network, ORA Office of Regulatory Science Quality Assurance 

programs/dietary supplement adulteration, FDA/USDA Food Emergency Response Network) as well as 

regulatory and food safety programs for milk, shellfish, vitamins, and food microbiology. FDA’s Moffett 

PT incorporates both food microbiological and chemical analytes and matrices based on the historical, 

current, and emerging food safety and defense requirements of the FDA. Microbiological PT schemes, 

for example, include bioterror agents such as B. anthracis (attenuated), Y. pestis (attenuated) or F. 

tularensis (attenuated strains) and food pathogens such as Listeria, Salmonella, Vibrio and others in 

variety of food products. Chemical PT schemes include glyphosate, tetramine, thallium, aflatoxin B1, 

carbamates, ricin and other toxins in a variety of food products. In addition, FDA’s Moffett PT schemes 

include detection for fraudulent weight loss and erectile dysfunction drugs in dietary supplements. 

Moffett PT’s expansive ISO/IEC 17043 accredited scope of work has greatly contributed to the 

groundwork built by FSMA for model laboratory standards, accreditation, and capacity/capability 

building of the nation’s food laboratory networks.

Office of Regulatory Affairs (ORA)

Through self-coordinated or collaborative method development & research to support regulatory 

testing, the ORA Office of Regulatory Science (ORS) laboratory network actively contributes to the 

repertoire of consensus analytical methods that are published in the AOAC’s compendium of the Official 

Methods of Analysis. According to 21CFR2.19, the Official Methods of Analysis of the AOAC 

INTERNATIONAL are specified to be used in cases where a method of analysis is not prescribed in the 

regulation.

Within the framework of a current FDA-USP Cooperative Research and Development Agreement 

(CRADA), ORA/ORS Laboratories also conduct analytical work aimed at updating and harmonizing USP 

pharmaceutical analysis monographs using USP reference materials.

ORA/ORS laboratories are accredited to ISO/IEC 17025 standards. The FDA Forensic Chemistry Center 

(FCC), the ORS forensics specialized lab, is accredited to the standards of ANSI-ASQ National 

Accreditation Board (ANAB) / American Society of Crime Lab Directors or ASCLD. Each laboratory 

conforms to the core requirements of a Quality Management System (QSM) which includes the design 

and maintenance of a proficiency testing and exercise schedule. This proficiency testing program of 

ORA/ORS laboratories is called the National Check Sample Program and aims to provide an assessment 

of laboratory proficiency in performance of analytical methods in the accreditation scope. Some 

proficiency tests utilized in the National Check Sample Program are internally generated sample panels 

prepared with third party vendor standard materials while other proficiency tests are obtained 
commercially.

ORA/ORS laboratories also conform to well established method validation and verification criteria such 

as ICH, USP, AOAC standards when qualifying their analytical methods.

Each laboratory in the ORA/ORS network is audited by an ISO/IEC 17025:2017 accreditor. In addition, 

the ORA/ORS labs specialized in pharmaceutical testing are also audited by the Pharmaceutical 

Inspection Convention and Pharmaceutical Co-operation Scheme (PIC/S) for conformance to established 

PIC/S standards.

ORA/ORS Laboratories are also active members of the Integrated Consortium of Laboratory Networks 

(ICLN) and CODEX International; and adopt consensus standards developed by these organizations that 

pertain to specialized testing areas such as veterinary drug residue testing, radiation testing, and 

pesticide testing.

ORA/ORS in coordination with CFSAN and CVM supports ISO/IEC 17025 accreditation of state food 

testing laboratories through the Manufactured Food Regulatory Program and the Flexible Funding 

Model. The program is aimed to advance the nationally integrated food safety system (IFSS) specifically 

with regards to microbiological and chemical food analyses. This includes preparing state laboratories 

for accreditation enhancements. Data generated by awarded state laboratories will be available to 

inform FDA in its enforcement actions, surveillance, and response to foodborne outbreaks. These ISO 

accredited laboratories can aid FDA with additional resources and exceptional data to maintain the 

safety of the food chain.

More detailed information on the Manufactured Food Regulatory Program and other standards-related 

programs managed by ORA can be accessed via the links below:

• Manufactured Food Regulatory Program Standards

• Flexible Funding Model

• National Integrated Food Safety System – Laboratory Capacity Building

• Voluntary National Retail Food Regulatory Program Standards

• Animal Feed Regulatory Program Standards

Center for Biologics Evaluation and Research (CBER)

In December of 2019, the Center for Biologics Evaluation and Research’s (CBER) Division of Biological 

Standards and Quality Control (DBSQC), which is in the Office of Compliance and Biologics Quality, was 

audited for ISO 17025:2017: “General requirements for the Competence of Testing and Calibration 

Laboratories” for the biological and chemical testing for product lot release, and ISO 17034:2016: 

“General Requirements for the Competence of Reference Material Producers.” These refence materials 

included influenza antigens and sheep antisera for influenza vaccine potency testing, as well as tetanus 

and diphtheria antitoxin for flocculation for DTaP vaccines. Accreditation was received for both ISO 

standards in April 2020 from the American Association for Laboratory Accreditation (A2LA) .

CBER’s Laboratory of Immunobiochemistry (LIB), in the Division of Bacterial, Parasitic and Allergenic 
Products, Office of Vaccines Research and Review, was also audited for ISO 17025: 2017 in December 

2019 and received A2LA accreditation in April 2020. The scope of accreditation for the LIB covers the 

“ELISA Competition Assay for Quantitative Determination of Relative Potency of Allergenic Extracts.”

In September 2020, a virtual internal audit was conducted for CBER to independently assess that DBSQC 

and LIB risk management, governance and internal control processes are operating effectively to the 

international standards ISO/IEC 17025 and 17034.

Identification of Medicinal Products (IDMP) is a suite of five standards developed within the 

International Organization for Standardization (ISO). These standards provide an internationallyaccepted framework to uniquely identify and describe medicinal products with consistent 

documentation, coding and exchange of product information between global regulators, manufacturers, 

suppliers and distributors. The IDMP suite of standards are a result of a need to standardize the 

definition of medicinal product and substance information to facilitate the unique identification and 

exchange of such information in the context of pharmacovigilance. As FDA focuses on the challenges of 

the global supply chain and foreign sourcing of medicinal products, FDA continues to participate in the 

development of and to promote the adoption of international harmonized IDMP to ensure the safety of 

medications throughout the world.

The 21st Century Cures Act was signed into law December, 2016. Section 3036 directs the FDA to 

collaborate with the National Institute of Standards and Technology (NIST) and FDA stakeholders to 

coordinate and prioritize standards development for regenerative medicine and regenerative medicine 

advanced therapies. In September 2017, CBER awarded a one-year contract to Nexight Group and the 

Standards Coordinating Body (SCB) to establish a collaboration consisting of FDA, NIST, and 

stakeholders, to coordinate the development and implementation of the processes and criteria to 

identify and prioritize standards that have a high impact on the quality and safety of regenerative 

medicine products and determine whether the development of any specific standard is feasible. The 

deliverables for this contract included written reports and webinars. In October 2018, this contract was 

extended through March 2019 to build on the foundation set by the original contract. The deliverables 

for the extended contract include the conduct of a two-day workshop on the development of 

documentary standards and reference materials applicable to regenerative medicine products. The 

goals of the workshop were to 1) build awareness of standards development processes and the value of 

engaging in standards development; 2) share knowledge of in-process standards advancement or 

development efforts; 3) identify experts who could be tapped to support/engage in future standards 

development; 4) identify working group members willing to commit to advance individual potential 

standards. In September 2020, FDA initiated another contract with Nexight Group and SCB to further 

support the development of standards for regenerative medicine products. Under the contract Nexight 

Group/SCB will conduct feasibility assessments for specific standards identified as needed standards by 

industry stakeholders. They will also develop an educational curriculum for the implementation of 

existing standards applicable to regenerative medicine products.

In March 2019, CBER published a final Guidance Document: Standards Development and the Use of 

Standards on Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research: 

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/standards-development-
and-use-standards-regulatory-submissions-reviewed-center-biologics-evaluation . This guidance 

document provides information to CBER stakeholders on CBER’s policy for utilizing voluntary standards 

to satisfy regulatory requirements such as product characterization and potency.

In addition to biologics, CBER has regulatory oversight for products that meet the definition of a medical 

device. As such, CBER participates in the S-CAP medical devices managed by CDRH and the ASCA Pilot 

Program.

Center for Drug Evaluation (CDER)

Section 3022 of the 21st Century Cures Act directs FDA to “establish a program to evaluate the potential 

use of Real World Evidence (1) to help to support the approval of a new indication for a drug approved 

under section 505(c); and (2) to help to support or satisfy post-approval study requirements.” Real 

World Evidence (RWE) is generated from data sources other than those typical of clinical trials used for 

drug approval. RWE sources include, but are not limited to, healthcare records, insurance claims, or 

dedicated registries for drugs or diseases. The interest in using RWE stems from its potential to facilitate 

more timely and cost-effective demonstrations of efficacy, safety, and the ability to understand drug 

effects across a wider population than currently possible with traditional clinical trials, thus providing 

improved benefits to the public.

As part of the 21st Century Cures directives, FDA is to create a framework establishing the RWE 

program, along with Guidance documents for industry, informed by communications with stakeholders 

from industry and the public. To fulfil these mandates, in 2017 CDER established a committee and 

associated workgroups dedicated to this effort with participation from multiple FDA Centers. 

Throughout 2017 and 2018, these groups have (1) developed a draft RWE Framework currently in 

clearance; (2) established workgroups to develop Guidance on a range of topics pertinent to the use of 

this data; (3) reviewed the range of RWE already in use for FDA submission; (4) and engaged with 

stakeholders from industries and the public through participation in meetings and workshops focused 

on the use of RWE for clinical research and regulatory submissions. Meetings were facilitated by 

stakeholders including the Margolis Center for Health Policy at Duke University and the National 

Academies of Sciences. Attending stakeholders at various meetings included a spectrum of 

representatives from the pharmaceutical industry, healthcare, academia, patient organizations, 

standards development organizations such as Health Level 7 (HL7) and Clinical Data Interchange 

Standards Consortium (CDISC), and other members of the general public. In 2019 the Center began 

examining the ability of current submission data standards to accommodate real-world data and 

develop a roadmap to optimizing these standards in the future for real-world data submission. As with 

other FDA data standards activity, consensus-based standards such as those from CDISC and HL7 are 

being explored. This work will continue apace with each other into 2021 and beyond.

FDA is also working to standardize submissions for the information submitted in Electronic Common 

Technical Document (eCTD) Module 3 covering Pharmaceutical Quality, Chemistry, Manufacturing, and 

Controls (PQ/CMC). In 2017, a Federal Register Notice was published documenting structured data and 

associated vocabularies for approximately one-third of Module 3 information. In 2019, development 

began on using HL7 FHIR as the exchange standard to represent PQ/CMC structured data for 
submissions. In 2020, the Center has initiated the standardization of the remaining information for eCTD 

Module 3.

ISO Identification of Medicinal Product (IDMP) is a suite of five related standards to identify and describe 

medicinal products and to exchange of product information between partners to support 

pharmacovigilance, product shortage, and other regulatory activities. The Integrity Product Domain and 

Global Substance Registration System are built based on ISO 11615/ISO 11616 and ISO 11238 

respectively to be the master repository for CDER regulated medicinal products and FDA regulated 

substances. To enable pharmacovigilance across multiple jurisdictions or at global level, FDA continues 

to participate in the revision and enhancement of IDMP standards with ISO TC215, and to collaborate 

with other regulators for harmonized approach for IDMP development.

5. Indian Health Service (IHS)

The primary mission of the Indian Health Service (IHS) is to raise the physical, mental, social, and 

spiritual health of American Indians and Alaska Natives to the highest level. Standards and conformity 

assessment activities are an integral part of the effective operations of the IHS in achieving its mission. 

There are health-related standards that are used for numerous purposes in the health industry. The IHS 

has used them for privacy/security, interoperability, compliance/accreditation, and certification.

Privacy and security standards are used throughout IHS and comply with Department of Homeland 

Security (DHS) requirements. Privacy and security standards are used for other purposes beyond those 

related to patient and employee data. The IHS also uses privacy and security standards to address 

communication of biomedical diagnostic and therapeutic information for digital imaging, telemedicine, 

national drug codes, energy-efficient and environmentally friendly construction, and for reporting 

medical services and procedures.

Interoperability is achieved within IHS through following standards from various development 

organizations, e.g. the use of Health Level Seven (HL7) schemas and International Classification of 

Disease, Tenth Edition (ICD-10) codes. The HL7 standard allows interoperability among health 

information systems both within and beyond the IHS healthcare environment, such as immunization 

data exchange (including COVID-19) to various state and federal partners. ICD-10 is a clinical cataloging 

system used by IHS and its providers, coders, information technology professionals in addition to

insurance carriers, government agencies and others use to properly note diseases on health records, 

track epidemiological trends, and assist in medical reimbursement decisions. It brings interoperability 

among disparate systems for information sharing.

Accreditation is a process of review in which healthcare organizations participate to demonstrate the 

ability to meet predetermined criteria and standards of accreditation established by a professional 

accrediting agency. DirectTrust Agent accreditation recognizes excellence in health data processing and 

transactions. It ensures compliance with industry-established standards, HIPAA regulations and the 

Direct Project. Accreditation granted by the DirectTrust Agent Accreditation Program for Health 

Information Service Providers from the Electronic Healthcare Network Accreditation Commission 

(EHNAC) and DirectTrust is valid for a two-year period; thereafter, a re-accreditation process take place.

Certification is a process by which an accreditation body assess and verifies the attributes of a product in 

accordance with established requirements or standards. Over the past decade the IHS successfully 

achieved certification of its Electronic Health Record for both ambulatory and inpatient settings against 
the 2011, 2014, and 2015 Edition standards published by the Office of the National Coordinator for 

Health Information Technology (ONC). This has allowed IHS, Tribal and Urban Indian healthcare 

organization hospitals and providers to qualify for various Centers for Medicare and Medicaid Services 

(CMS) Meaningful Use incentives authorized by the Health Information Technology for Economic and 

Clinical Health (HITECH) Act and to participate in CMS Quality Payment Programs. IHS is currently 

undertaking the process to complete the requirements for the ONC 2015 Edition Cures Update, per 

ONC’s timeline in the Federal Register. The IHS has utilized and incorporated numerous information 

technology standards promulgated by development organizations and specified in the various ONC Final 

Rules in order to meet the rigorous certification requirements.

The IHS Office of Information Technology maintains a website that references a number of the 

standards and policies in use by the agency that can be found at: 

https://www.ihs.gov/oit/standardspolicy/

6. National Institutes of Health (NIH)

National Cancer Institute (NCI)

The Nanotechnology Characterization Laboratory (NCL) is part of the National Cancer Institute (NCI)’s 

Alliance for Nanotechnology in Cancer and falls under the umbrella of the NCI’s Cancer Imaging Program 

within the Division of Cancer Treatment and Diagnosis. The NCL is operated by Leidos Biomedical 

Research (contractor) as part of the Frederick National Laboratory for Cancer Research.

The mission of the NCL is to advance the science of nanoparticle characterization. As part of these 

efforts, the NCL has developed more than 70 assays for nanomaterial characterization, termed NCL’s 

Assay Cascade. All NCL assays are published on the NCL website and free to download: 

https://ncl.cancer.gov/resources/assay-cascade-protocols. These assays have been tested against a wide 

variety of nanomaterial platform types and are updated as necessary. This year, six new protocols were 

added to our catalogue. These include:

• STE-4: Detection of ß-Glucan Contamination

• PCC-18: Quantitation of APIs in Polymeric Prodrug Formulations

• PCC-19: Asymmetric-Flow Field-Flow Fractionation

• PCC-20: Particle Concentration & Size using the Spectradyne nCS1

• PCC-21: Measuring Size and Number Concentration of Metallic Nanoparticle using single particle-ICPMS

• ITA-27: Multiplex Enzyme-Linked Immunosorbent Assay (ELISA) for Detection of Human Cytokines in 

Culture Supernatants

NCL team members are also active participants of the standards organizations ASTM International and 

ISO, which develop voluntary consensus standards. NCL staff serve as subject matter experts in various 

nanotech-related working groups within these organizations. Efforts were initiated in 2020 to bring 12 

NCL protocols through ASTM as Standard Practice or Standard Guides. These efforts are continuing into 

2021.

National Library of Medicine (NLM)

The National Library of Medicine (NLM) has been a center of information innovation since its founding in 
1836. The world’s largest biomedical library, NLM maintains and makes available a vast print collection 

and produces electronic information resources on a wide range of topics. NLM also supports and 

conducts research, development, and training in biomedical informatics and health information 

technology. In addition, the Library coordinates the 8,000-member Network of the National Library of 

Medicine that promotes and provides access to health information in communities across the United 

States.

NLM is active at a national level in the creation, review, and ongoing maintenance of standards related 

to the basic functions of a library including interlibrary loan, collection preservation, bibliographic 

control, and database creation and access. NLM’s goal is to ensure these standards are workable for the 

library community as a whole. NLM participates in the National Information Standards Organization 

(NISO). Because NISO decisions feed into the decision-making process of the American National 

Standards Institute (ANSI), the official U.S. representative to the International Organization for 

Standardization (ISO), NLM’s activities extend to the development of standards at an international level. 

One example of an important NISO standard developed by NLM is the Journal Article Tag Suite, which is 

an outgrowth of NLM’s work on the PubMed Central journal article archive. Another example is NLM’s 

participation in the development of NISO’s new Recommended Practice: PIE-J: Presentation & 

Identification of E-Journals. Pie-J provides guidance to publishers of electronic journals on the 

presentation and identification of electronic journals to ensure long-term online accessibility to scholarly 

journals even after titles and publishers change.

For more than four decades, NLM has conducted and supported groundbreaking research and 

development related to the representation, interpretation, and use of biomedical knowledge in 

electronic forms including electronic health records (EHRs). NLM has been the central coordinating body 

for clinical terminology standards within the Department of Health and Human Services (HHS) since 

2004. In this role, NLM is the official depository and distribution center for clinical terminologies, 

responsible for integrating them within the Unified Medical Language System (UMLS) Metathesaurus 

and for developing and maintaining mappings between designated standard clinical terminologies and 

important related terminologies, including the HIPAA code sets. NLM works with (and, in some cases, 

provides funding to) vocabulary developers, message standards development organizations, other 

Federal agencies, and users of standards to fulfill its role as the central coordinating body for clinical 

terminology standards and to respond to recommendations from the Health Information Technology 

Advisory Committee. Clinical terminology standards and resources supported or produced by NLM 

includes:

- UMLS Metathesaurus – Produced by NLM, this resource incorporates many different vocabularies, 

classifications, and code sets;

- LOINC (Logical Observations Identifiers Names and Codes) – NLM funds the ongoing maintenance and 

free distribution of this standard with codes names and other information for reporting and ordering 

laboratory tests , measurements, survey instrument and other kinds of observations (accessible within 

the UMLS Metathesaurus and from the Regenstrief Institute);

- SNOMED CT – NLM is the US representative to SNOMED International and as such pays the annual fee 

that permits U.S.-wide use of SNOMED CT (comprehensive clinical healthcare terminology; accessible 

within the UMLS Metathesaurus and in native format from NLM) and creation and distribution of the 

U.S. Edition of SNOMED CT;

- RxNorm – NLM produces and distributes RxNorm (terminology for clinical drugs; accessible both within 

the UMLS Metathesaurus and separately from NLM).
LOINC, SNOMED CT, and RxNorm form a suite of key clinical terminology standards that have been 

designated for use in the U.S. healthcare systems over the past 20 years:

- Consolidated Health Informatics (CHI; active 2001 - 2007) - eGov project designated the suite as U.S. 

Government-wide clinical standards for use in U.S. Federal Government healthcare systems.

- Healthcare Information Technology Standards Panel (HITSP; active 2005 - 2010) - identified the suite in 

various interoperability specifications for use throughout the U.S. healthcare spectrum. The suite was 

required for use in U.S. Federal Government healthcare systems, recommended for use in the private 

sector.

- Health Information Technology for Economic and Clinical Health (HITECH) Act - In July 2010 the suite 

were named as standards to support stage 1 meaningful use in the “Health Information Technology 

Standards, Implementation Specifications, and Certification Criteria and Certification Programs for 

Health Information Technology” Final Rule. Subsequent final rules for EHR certification criteria (2011, 

2014, and 2015 Editions) each expanded the requirements for use of the suite to support meaningful 

use.

- United States Core Data for Interoperability (USCDI) – Established by the Office of the National 

Coordinator for Health Information Technology (ONC) as part of the Cures Act Final Rule, USCDI is a 

standardized set of health data classes and constituent data elements for nationwide, interoperable 

health information exchange. A USCDI data element is the most granular level at which a piece of data is 

exchanged. The USCDI specifies the set of coding systems that are required for use in US electronic 

medical record systems to support interoperable health information exchange. In this system, SNOMED 

CT, LOINC, and RxNorm are all required for use for designated purposes.

- Interoperability Standards Advisory (ISA) – Established by the Office of the National Coordinator for 

Health Information Technology (ONC), ISA is the model by which ONC coordinates the identification, 

assessment, and public awareness of interoperability standards and implementation specifications for 

use in healthcare systems. ISA specifies LOINC, SNOMED CT, and RxNorm as the preferred coding system 

for designed purposes.

- Health Level Seven (HL7) Standards for Genetics – LOINC has been selected as the core structure of 

three HL7 standards genetics including 1) HL7 V2 specification for cytogenetics, 2) laboratory reporting 

of genetic variants, and 3) HL7 FHIR specification for clinical genetic reports.

- LOINC In Vitro Diagnostic (LIVD) Test Code Mapping for SARS-CoV-2 Tests – Announced by HHS on June 

4, 2020, LIVD is new laboratory data reporting guidance for COVID-19 testing. LIVD uses LOINC and 

SNOMED CT to identify and report SARS-CoV-2 test results in electronic reporting systems to facilitate 

timely and quality data reporting to state and federal public health agencies 

(https://www.cdc.gov/csels/dls/sars-cov-2-livd-codes.html).

- Health Level Seven (HL7) Fast Healthcare Interoperability Resources (FHIR) – NLM has been an active 

proponent of the FHIR standard that is now supported at the National Institutes of Health (NIH) level to 

support data science (see https://datascience.nih.gov/fhir-initiatives). Both the Office of the National 

Coordinator for Health Information Technology (ONC) and the Centers for Medicare and Medicaid 

Services (CMS) include requirements for use of FHIR in recent rulemaking related to the 21st Century 

Cures Act. NLM’s specific focus is on exploring the creation of FHIR-compliant API for clinical research 

use, starting by standardizing phenotype data for several large population cohort studies archived within 

the database of Genotypes and Phenotypes (DbGap). NLM has also developed a number of software 

tools to facilitate use of FHIR (https://lhcforms.nlm.nih.gov). NLM’s National Center for Biotechnology 

Information (NCBI) maintains databases of genetic variants (ClinVar, dbSNP) that are required coding 
systems for HL7 FHIR genetic reporting (http://ncbi.nlm.nih.gov).

In addition, SNOMED CT is the standard for selected data elements in international genetic information 

resources, including the NIH Genetic Testing Registry and the ClinVar database of clinically significant 

human variations. It is also being used in an increasing number of clinical research studies.

NLM, on behalf of HHS, is the U.S. Member of the International Health Terminology Standards 

Development Organisation (IHTSDO; using the trading name SNOMED International) which owns, 

maintains, and distributes SNOMED CT internationally and promotes global standardization of health 

information. As the US Member, NLM produces and distributes:

- US Edition to SNOMED CT – combination of the U.S. Extension and the International Release of 

SNOMED CT. The U.S. Edition to SNOMED CT is the version of SNOMED CT cited as CMS Promoting 

Interoperability program requirements. The US Extension is a formal extension of the International 

Release that allows NLM to provide both rapid access to SNOMED CT concepts needed by U.S. 

stakeholders, as well as standard terminology needed for U.S. clinical use cases (e.g. regulatory or 

legislatively mandated terms specific to the U.S.) that are not generally useful in other countries.

- CORE Problem List Subset of SNOMED CT – updated 4 times per year (with each new release of 

SNOMED CT and the UMLS Metathesaurus). The Subset is designed to facilitate the use of SNOMED CT 

for coding of problem list data in EHRs and to enable more meaningful use of EHRs to improve patient 

safety, health care quality, and health information exchange. Development and distribution of this initial 

subset was used as a model for development of other frequency-based subsets to facilitate 

implementation of SNOMED CT, LOINC, and RxNorm throughout the U.S. including:

o SNOMED CT Route of Administration

o Nursing Problem List Subset of SNOMED CT

o Universal Laboratory Order Codes from LOINC and Common UCUM Codes (both created in 

conjunction with the Regenstrief Institute)

o RxNorm Current Prescribable Content

- Mappings - between standard clinical vocabularies, HIPAA code sets, and other key vocabularies used 

in Federal health information systems. The mappings are intended to facilitate development and 

implementation by health care providers of EHRs that capture clinical data at the point of care and 

subsequently support generation of required HIPAA code set data for claims and other administrative 

transactions. Mappings maintained and distributed by NLM:

o SNOMED CT to ICD-10 – updated and expanded in conjunction with the IHTSDO

o SNOMED CT to ICD-10-CM – builds on and makes use of the tools and policies developed for the 

IHTSDO mapping project.

o ICD-9-CM to SNOMED CT – Designed to further facilitate the transition from ICD-9-CM to SNOMED CT, 

NLM makes available maps from heavily used ICD-9-CM procedure codes to SNOMED CT as well as the 

map from heavily used ICD-9-CM diagnostic codes to SNOMED CT. Both maps are based on in-patient 

claims data obtained from CMS.

- Nursing Resources for Standards and Interoperability - a resource for anyone interested in nursing 

terminologies for systems development. The page describes the role of SNOMED CT and LOINC in 

implementing meaningful use, specifically for the nursing and care domain.

As the U.S. Member of the IHTSDO NLM also:

- Makes available the U.S. SNOMED CT Content Request System (USCRS) in support of the U.S. Extension 

to SNOMED CT. USCRS is a mechanism for U.S. stakeholders to request changes to SNOMED CT (e.g. new 

concepts or enhancements to existing concepts). The long-term goal is to allow the establishment of a 
network for U.S. contributions to the development of SNOMED CT by both government agencies and 

private sector organizations and enable collaboration with other IHTSDO member countries in the 

development of SNOMED CT content and subsets.

- Facilitates alignment and harmonization - NLM continues working with the IHTSDO to facilitate 

alignment and harmonization between SNOMED CT and other key health terminologies, most notably 

with LOINC.

NLM provides access to several additional resources to make standards more accessible:

- MedlinePlus Connect - a free service that delivers consumer-oriented information about relevant 

conditions and disorders, health and wellness, and prescription and over-the-counter medications to 

patients, families, and health care providers via EHR systems. The system works by accepting specific 

requests from EHR systems and providing in response links to relevant consumer health information 

from NLM’s MedlinePlus system. To facilitate the connection, NLM mapped all MedlinePlus health 

topics pages to standard coding systems used in EHRs. Specifically, MedlinePlus Connect responds to 

requests for information based on diagnosis (problem) codes (SNOMED CT CORE Problem List Subset, 

ICD-9-CM, ICD-10-CM), medication codes (RxNorm, NDC), and lab test codes (LOINC). Code requests will 

then receive relevant health information from MedlinePlus, Genetics Home Reference, and other 

reliable health resources.

- Value Set Authority Center (VSAC) - NLM, in collaboration with the Office of the National Coordinator 

for Health Information Technology (ONC) and Centers for Medicare & Medicaid Services (CMS) created 

VSAC, which was launched in early FY2013. The system has since been expanded to include an authoring 

tool that allows users to author value sets in a collaborative environment. NLM continues working with 

ONC and CMS to enhance and expand VSAC to meet the community’s needs.

- AccessGUDID (Global Unique Device Identification Database) – NLM, in conjunction with the Food and 

Drug Administration (FDA), introduced AccessGUDID in FY2015. This web resource contains key device 

identification information submitted to the FDA about medical devices that have Unique Device 

Identifiers (UDI).

- Newborn Screening laboratory reporting – NLM, in collaboration with CDC, FDA, Health Resources and 

Services Administration (HRSA), and other NIH institutes and centers, as well as with the American 

Public Health Laboratory (APHL) and many state public health departments develop and maintain an 

HL7 v.2.5.1 laboratory reporting guide for newborn screening result reporting. The guide leverages 

LOINC, SNOMED CT, and HL7 messaging structures to support the timely communication of newborn 

screening results and conditions.

- NIH Common Data Elements (CDE) Repository - developed and maintained by NLM on behalf of NIH, 

the CDE repository provides access to structured human and machine-readable definitions of data 

elements that have been recommended or required by NIH for use in research and other purposes. The 

repository helps facilitate standardization by providing tooling (search, browse, compare) that can be 

used in the harmonization and de-duplication of data elements.

NLM works closely with the HHS Office of the National Coordinator for Health Information Technology 

(ONC) to ensure NLM’s vocabulary harmonization and standards efforts are in sync with those of ONC 

and the Health Information Technology Advisory Committee (HITAC). NLM participates in the HITAC and 

has participated in its predecessors, the Health IT Policy Committee and the Health IT Standards 

Committee as a member. HITAC assumes responsibility for evaluating vocabularies and information 

models needed to achieve greater interoperability across healthcare systems, to “Promote 

Interoperability”, and other federal requirements. NLM also participates in the Federal Health IT 
Coordinating Council.

NLM participates in the International Organization for Standards (ISO) Health Informatics Technical 

Committee (ISO/TC 215) to provide advice at the national (ANSI) and international (ISO) levels. This 

groups scope is “standardization in the field of health informatics, to facilitate capture, interchange and 

use of health-related data, information, and knowledge to support and enable all aspects of the health 

system.

A complete list of NLM’s activities relating to health information technology and health data standards is 

available from the NLM Website at http://www.nlm.nih.gov/healthit.html.

7. Office of the National Coordinator (ONC)

Standards are an integral component of ONC’s mission to support the development of a nationwide 

health information technology (health IT) infrastructure that allows for electronic use and exchange of 

information in a scalable manner, promotes the adoption of interoperable health IT in a cost effective 

manner, and provides leadership in the development, recognition, and implementation of standards and 

certification of health IT products. The consistent use of health IT standards is a necessary requirement 

to achieve interoperability of health information, which is a central key to reducing health care costs.

The United States Core Data for Interoperability (USCDI) is a standardized set of health data classes and 

constituent data elements for nationwide, interoperable health information exchange. It establishes a 

baseline set of data that can be commonly exchanged across care settings for a wide range of uses. ONC 

published a Draft USCDI version 1 (USCDI v1) and the associated data classes and data elements for 

public comment as part of the ONC Cures Act notice of proposed rulemaking. ONC also charged the 

Health Information Technology Advisory Committee (HITAC) to create a taskforce to consider the Draft 

USCDI v1 and the related update timeline and expansion process. In consideration of the input received 

from public comment in response to ONC’s proposed rule and from the HITAC task force, the USCDI v1 

was adopted as a standard in the ONC Cures Act Final Rule published May 1, 2020.

The USCDI’s impact is not limited to health IT products certified under the ONC Health IT Certification 

Program. The ONC Cures Act Final Rule provisions related to “information blocking” also reference the 

USCDI as the initial scope of electronic health information (EHI) healthcare providers, health information 

networks and exchanges, and developers of certified health IT need to consider when it comes to the 

access, exchange, and use of EHI. Please see the USCDI v1 and the USCDI Fact Sheet for more 

information.

The Standards Version Advancement Process (SVAP) enables health IT developers to voluntarily 

incorporate newer versions of specific ONC-regulated standards and implementation specifications into 

their products under the ONC Health IT Certification Program, including future versions of the USCDI. 

The SVAP will advance interoperability by permitting developers of certified health IT to implement 

newer versions of standards and specifications than currently adopted in regulation. ONC established an 

annual public comment process for SVAP-eligible standards and implementation specifications.

Following a detailed review and assessment of comments received during the comment period for 2020 

SVAP-eligible standards and implementation specifications (September – November 2020), ONC 

finalized a list of standards and implementation specifications that can be advanced to under the ONC 
Health IT Certification Program. Please see the SVAP Approved Standards for 2020 on the ONC 

Certification Program SVAP webpage.

To support HHS’s ongoing response efforts to the outbreak of Coronavirus Disease 2019 (COVID-19), 

ONC has partnered with the Centers for Disease Control and Prevention (CDC) to share various 

resources for reporting and tracking COVID-19, as well as general clinical guidance to the health IT 

community and healthcare providers. Health IT now plays a crucial role in the collecting and reporting of 

COVID-19 data. Additionally, electronic health information exchange can facilitate effective strategies to 

combat COVID-19.

Related Links:

• https://www.healthit.gov/topic/standards-technology/onc-standards-bulletin

• https://www.healthit.gov/isa/united-states-core-data-interoperability-uscdi

• https://www.healthit.gov/isa/sites/isa/files/2020-10/USCDI-Version-1-July-2020-Errata-Final_0.pdf

• https://www.federalregister.gov/documents/2020/05/01/2020-07419/21st-century-cures-actinteroperability-information-blocking-and-the-onc-health-it-certification

• https://www.healthit.gov/cures/sites/default/files/cures/2020-03/USCDI.pdf

• https://www.healthit.gov/isa/standards-version-advancement-process

• https://www.healthit.gov/topic/standards-version-advancement-process-svap

• https://www.healthit.gov/coronavirus

8. Substance Abuse and Mental Health Services Administration (SAMHSA)

The Substance Abuse and Mental Health Services Administration (SAMHSA) is a member of the National 

Quality Forum (NQF), a voluntary consensus body for performance measurement. SAMHSA works with 

NQF, as well as public and private-sector partners, as part of NQF’s Measure Application Partnership to 

recommend quality measures to the Department of Health and Human Services (HHS) for federal 

reporting.

Additionally, SAMHSA works with NQF, as well as private and public stakeholders, as part of the 

Medicaid and Children’s Health Insurance Program Scorecard Workgroup that provides input to HHS on 

quality measures that will be included in the Centers for Medicare and Medicaid Services (CMS) public 

reporting efforts.

As a member of the NQF, SAMHSA collaborates with a number of federal partners, including, the office 

of the Assistant Secretary for Planning and Evaluation, and CMS, to develop behavioral health quality 

measures that address key gaps in the field related to substance use and mental health disorders. Some 

of these measures have been used in different stages of “Meaningful Use” and are now part of the 

Medicaid Adult Core Set of Measures.

These Adult Healthcare Quality measures can be found at: https://www.medicaid.gov/medicaid/qualityof-care/performance-measurement/adult-and-child-health-care-quality-measures/adult-health-carequality-measures/index.html

2021 Core Set of Adult Health Care Quality Measures for Medicaid (Adult Core Set): 
https://www.medicaid.gov/medicaid/quality-of-care/downloads/2021-adult-core-set.pdf

2. Please list the government-unique standards (GUS) your agency began using in lieu of voluntary 

consensus standards during FY 2020. Please note that GUS which are still in effect from previous years 

should continue to be listed, thus the total number in your agency's report will include all GUS 

currently in use (previous years and new as of this FY): 1

(1) Government Unique Standard

FDA Guidelines on Asceptic Processing (2004) [Incorporated: 2004]

Voluntary Standard

ISO 13408-1 Asceptic Processing of Health Care Products, Part 1, General Requirements

Rationale

FDA is not using the ISO standard because the applicability of these requirements is limited to only portions of aseptically 

filtration, freeze-drying, sterilization in place, cleaning in place, or barrier-isolator technology. There are also significant is 

substance that are not included in the document