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Docket Number:
FDA-2020-D-1138
Issued by:

FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.

  • The Lincoln-Lancaster County Health Department brought together key people from our community to form an advisory group around the topic of vaccinations. This group has been advising and making recommendations regarding local decisions related to influenza and COVID testing, along with planning for administering the COVID-19 vaccine.
  • A federal government website managed and paid for by the U.S Centers for Medicare & Medicaid Services. 7500 Security Boulevard, Baltimore, MD 21244.

FDA is issuing this guidance to provide a policy to help expand the availability of general use face masks for the general public and particulate filtering facepiece respirators (including N95 respirators) for healthcare personnel (HCP)1 for the duration of the COVID-19 public health emergency.

This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2)).

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The mission of the Health Department is to promote, protect and assure the health, safety, and quality of life through assessment, policy development and assurance, in order that our community will be a safe, healthy place for our citizens to live and raise families.

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Given this public health emergency, and as discussed in the Notice in the Federal Register of March 25, 2020, titled 'Process for Making Available Guidance Documents Related to Coronavirus Disease 2019,' available at https://www.govinfo.gov/content/pkg/FR-2020-03-25/pdf/2020-06222.pdf, this guidance is being implemented without prior public comment because FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(h)(1)(C)) and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices.

Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2020-D-1138.

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