Regulatory Response & Advocacy

​​​​​​​​​​​​​​​APHL’s Policy Program promotes the work of governmental public health laboratories by advocating for a sustainable laboratory network and voicing the impact of federal regulatory rules on public health laboratories.

Informatics Policy Initiatives

​​​APHL is committed to improving population health through informatics, health IT and information exchange and works to assure that informatics standards and architectures support the critical work of public health laboratories. Learn more. 

Food Safety

APHL Comment FSIS Accredited Laboratory Program (February 2021)

APHL Comment NARMS Strategic Plan (November 2020)

APHL Comment FSIS Salmonella Roadmap (October 2020)

APHL Comment Laboratory Accreditation for Analysis of Foods (March 2020)

APHL Comment New Era of Smarter Food Safety (November 2019)

Cannabis

APHL Comment to AMS (January 202​0)​

APHL Comment to FDA (July 2019​​​)

Environmental Health

APHL Comment To HHS Environmental Justice Strategy Draft​ (June 2022)

APHL Comment to EPA Strategic Plan 2022-2026 (November 2021)

APHL Response to NIH Climate and Health RFI (September 2021)

APHL Comment CDC LEPAC (October 2020)

APHL Comment EPA Transparency Rule (May 2020)

APHL Comment to EPA On Lead and Copper Rule Revisions (March 2020)​​

APHL Comment to​ EPA on Water Reuse (December 2019)

​APHL Comment to CMS on Lead Testing (April 2019)​​

Infectious Disease

APHL Comment to USDA APHIS Proposed Frameowwork for SARS-CoV-2 and Other Emerging Zoonotic Diseases (October 2021) 

FDA Re-classification of HIV/HCV Diagnostics

APHL supports the reclassification of these devices from Class III to Class II to improve access to state of the art HIV and HCV tests, patient diagnosis, laboratory efficiency, patient management, and public health surveillance.

• Federal Register (February 2018)

• APHL Comment (March 2018)

• APHL Letter to FDA (July 2018)

• APHL Letter to FDA (June 2019)
  

• APHL Comment (January 2022)
  

CLIA/CLIAC

• APHL Regulatory Issue Summary for Public Health Laboratories (2018)

• APHL Comment (March 2018)

• APHL Oral Comment (Lab Director Qualifications) CLIAC Meeting (November 2018)

• APHL Oral Comment (NGS) CLIAC Meeting (April 2019)

• APHL Oral Comment CLIAC Meeting (November 2019)

• APHL Comment CLIAC​ (September 2020)

2018 Common Rule

Federal policy that protects human subjects in federally funded research. Revised Common Rule in effect as of 7/19/18.

• HHS OHRP Revised Common Rule

• HHS OHRP FAQ: Newborn Screening

• Official 2018 Requirements in 45 CFR 46 of the July 19, 2018 edition of the e-Code of Federal Regulations

• APHL Issue Summary for Public Health Laboratories (2015)

• APHL Comment: Response to Notice of Proposed Rulemaking (2016)

Laboratory Developed Tests

Response to congressional and FDA activities regarding revised oversight of in vitro diagnostic tests including LDTs.

• APHL Recorded Presentation on the LDT Final Rule and Slides​ (August 2024)

• APHL ​​​​Comments on the LDT Draft Guidances​ (July 2024)
  

• Self-guided APHL Presentation on the LDT Final Rule​ (May 2024)

• APHL ​​​​Comments on the LDT Proposed Rule​​ (December 2023)
  

• APHL ​​​​Template for Comments on the LDT Proposed Rule​ (November 2023)

• Federal Register​ (October 2023)​​
  

• Federal Register (October 2014)

• Regulatory Docket (October 2014)

• APHL Issue Summary for Public Health Laboratories (October 2014)

• APHL Comment (January 2015)

• APHL Letter to DAIA Bill Sponsors (August 2018)
  

• APHL Lette​r to HELP Committee Regarding FDASLA (May 2022)
  

CMS Reimbursement Rates

Data Integrity of Private Payer Rates of CLFS

APHL joined organizations in the laboratory community to raise concerns of the integrity of the data CMS collected when determining accurate weighted median of private payer rates for tests on the Clinical Laboratory Fee Schedule (CLFS). The letters urge Seema Verma, Administrator of CMS, to involve all stakeholders when calculating and establishing pricing.

• Sign-on Letter (October 2017)

• Sign-on Letter (March 2018)

CLFS Funding Cuts

APHL led a group of governmental public health organizations in a letter to Congress to oppose the cuts to the CLFS that were set to take place in January 2018. ASTHO, NACCHO, CSTE, AMCHP, NASTAD and NCSD joined APHL in calling on Congress to immediately suspend the implementation of the new CLFS rates which cut testing of public health importance up to 35-40%.

• Sign-on Letter (December 2018)

Repeal of Prevention and Public Health Fund

​APHL sent letters to Senate leadership stating to continue provide funding for critical public health programs that are currently funded from the Prevent​ion and Public Health Fund (PPHF), a component of the Affordable Care Act (ACA).

• Sign-on Letter (January 2018)

• APHL Letter: Graham-Cassidy healthcare legislation (September 2017)

• Sign-on Letter (May 2017)
  

• Sign-on Letter (March 2017)
  

• Sign-on Letter (January 2017)
  

Zika Funding

APHL joined on two letters to congressional leadership urging continued federal funding for Zika response activities. 

• Sign-on Letter (March 2017)

• ​Sign-on Letter (February 2016​​​)

• HHS Secretary to Congress: Redirected Zika Funding is Running Out (August 2016)

• ​APHL Zika Fact Sheet to Congress

Select Agents

• APHL Issue Summary for Public Health Laboratories, Select Agent Rule (January 2016)

• APHL Comment (October 2015)

• ​CDC Notice of Propo​sed Rulemaking to Update Select Agent Rules (2015)

• Regulatory Docket (2015)

Multiplex Nucleic Acid Amplification​ Test​

• Response, Respiratory Viral Pathogens (December 2018)

• Final LCD, Foodborne GI Pathogens (December 2018)

• Final LCD, Respiratory Viral Pathogens (December 2018)

• ​Response, Foodborne GI Pathogens (October 2018)

• APHL Letter (July 2017)​​​

• Joint Comment, Foodborne GI Panel ​(July 2017)

• Joint Comment, Respiratory Viral Panel​ (July 2017)