Legal Status
This site displays a prototype of a “Web 2.0” version of the daily Federal Register. It is not an official legal edition of the Federal Register, and does not replace the official print version or the official electronic version on GPO’s govinfo.gov.
The documents posted on this site are XML renditions of published Federal Register documents. Each document posted on the site includes a link to the corresponding official PDF file on govinfo.gov. This prototype edition of the daily Federal Register on FederalRegister.gov will remain an unofficial informational resource until the Administrative Committee of the Federal Register (ACFR) issues a regulation granting it official legal status. For complete information about, and access to, our official publications and services, go to About the Federal Register on NARA's archives.gov.
The OFR/GPO partnership is committed to presenting accurate and reliable regulatory information on FederalRegister.gov with the objective of establishing the XML-based Federal Register as an ACFR-sanctioned publication in the future. While every effort has been made to ensure that the material on FederalRegister.gov is accurately displayed, consistent with the official SGML-based PDF version on govinfo.gov, those relying on it for legal research should verify their results against an official edition of the Federal Register. Until the ACFR grants it official status, the XML rendition of the daily Federal Register on FederalRegister.gov does not provide legal notice to the public or judicial notice to the courts.
Health and Human Services Department
The Department of Health and Human Services (HHS) was created as the Department of Health, Education, and Welfare on April 11, 1953 (5 U.S.C. app.).
HHS is the Cabinet-level department of the Federal executive branch most involved with the Nation's human concerns. In one way or another, it touches the lives of more Americans than any other Federal agency. It is a department of people serving people, from newborn infants to persons requiring health services to our most elderly citizens.
- Agency URL:
- http://www.hhs.gov/
- Sub-agencies:
- Agency for Healthcare Research and Quality
- Agency for Toxic Substances and Disease Registry
- Aging Administration
- Centers for Disease Control and Prevention
- Centers for Medicare & Medicaid Services
- Child Support Enforcement Office
- Children and Families Administration
- Family Assistance Office
- Food and Drug Administration
- Health Resources and Services Administration
- Indian Health Service
- Inspector General Office, Health and Human Services Department
- National Institutes of Health
- National Library of Medicine
- Program Support Center
- Public Health Service
- Refugee Resettlement Office
- Substance Abuse and Mental Health Services Administration
- Health Care Finance Administration
- Community Living Administration
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Securing Updated and Necessary Statutory Evaluations Timely
Editorial Note: The Office of the Federal Register made technical corrections to this document after it was posted for public display. It will remain on display through the close of business on January 19, 2021.
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Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods; Correction
The Food and Drug Administration (FDA or we) is correcting a final rule that published in the Federal Register of August 13, 2020. The final rule establishes requirements concerning ``gluten-free'' labeling for foods that are fermented or hydrolyzed or that contain fermented or hydrolyzed ingredients.
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Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods
The Food and Drug Administration (FDA or we) is issuing a final rule to establish requirements concerning ``gluten-free'' labeling for foods that are fermented or hydrolyzed or that contain fermented or hydrolyzed ingredients. These requirements f are needed to help ensure that individuals with celiac disease are not misled and receive truthful...
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Laboratory Accreditation for Analyses of Foods; Extension of Comment Period
The Food and Drug Administration (FDA or we) is extending for a second time the comment period for the proposed rule, and for the information collection related to the proposed rule, entitled ``Laboratory Accreditation for Analyses of Foods'' that appeared in the Federal Register of November 4, 2019. We are taking this action in response to a...
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Premarket Tobacco Product Applications and Recordkeeping Requirements; Reopening of the Comment Period
The Food and Drug Administration (FDA or the Agency) is reopening the comment period only for the agency information collection activity associated with proposed rulemaking entitled ``Premarket Tobacco Product Applications and Recordkeeping Requirements,'' which appeared in the Federal Register of September 25, 2019. FDA is not reopening the...
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Laboratory Accreditation for Analyses of Foods; Extension of Comment Period
The Food and Drug Administration (FDA or we) is extending the comment period for the proposed rule, and for the information collection related to the proposed rule, entitled ``Laboratory Accreditation for Analyses of Foods'' that appeared in the Federal Register of November 4, 2019. We are taking this action in response to a request for an...
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Tobacco Products; Required Warnings for Cigarette Packages and Advertisements; Delayed Effective Date
As required by an order issued by the U.S. District Court for the Eastern District of Texas, this action delays the effective date of the final rule (``Tobacco Products; Required Warnings for Cigarette Packages and Advertisements''), which published on March 18, 2020. The new effective date is January 14, 2022.
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Supplemental Evidence and Data Request on Interventional Treatments for Acute and Chronic Pain: Systematic Review
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Interventional Treatments for Acute and Chronic Pain: Systematic Review, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC)...
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Notice of Meetings
The subcommittees listed below are part of AHRQ's Health Services Research Initial Review Group Committee. Grant applications are to be reviewed and discussed at these meetings. Each subcommittee meeting will be closed to the public.
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Notice of Availability of a Draft Policy Statement for the Biosafety of Large Animal Study-Related Activities With Brucella abortus and Brucella suis Using Outdoor Containment Spaces
The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) is opening a public docket to obtain comment on a draft Brucella policy statement. This draft policy statement, when finalized, will aid individuals and entities in the development of biosafety plans for outdoor large animal studies...
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Advisory Committee on Immunization Practices (ACIP)
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), announces the following meeting of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public. Time will be available for public comment. The meeting will be webcast live via the World Wide Web.
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TG United Inc., et al.; Withdrawal of Approval of 27 Abbreviated New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 27 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
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Patient-Focused Drug Development for Vitiligo; Public Meeting; Request for Comments
In the Federal Register notice published on March 19, 2020, the Food and Drug Administration (FDA, Agency, or we) announced the cancellation of the public meeting entitled ``Patient-Focused Drug Development for Vitiligo'' originally scheduled to occur on March 30, 2020, as announced in the Federal Register on February 12, 2020. FDA is announcing...
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Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards; Public Meeting; Request for Comments
The Food and Drug Administration (FDA or Agency) is announcing the following virtual public meeting entitled ``Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards.'' The purpose of the virtual public meeting and the request for comments is to fulfill FDA's commitment to seek stakeholder input related to data...
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Making Permanent Regulatory Flexibilities Provided During the COVID-19 Public Health Emergency by Exempting Certain Medical Devices From Premarket Notification Requirements; Request for Information, Research, Analysis, and Public Comment on Opportunities for Further Science and Evidence-Based Reform of Section 510(k) Program
To provide Americans with expanded access to certain medical devices to respond to the COVID-19 Public Health Emergency, FDA issued guidance documents providing numerous regulatory flexibilities, including a temporary waiver of premarket notification requirements under section 510(k) of the Food, Drug, and Cosmetic Act. For seven class I devices...