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
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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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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Regulatory Clean Up Initiative; Correction
The Department of Health and Human Services is correcting a final rule that appeared in the Federal Register on November 16, 2020. This document had incorrectly designated footnotes and typographical errors.
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Agency Information Collection Activities; Proposed Collection; Public Comment Request; Independent Living Services (ILS) Program Performance Report (PPR) 0985-0043
The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish a notice in the Federal Register concerning each proposed collection of information, including...
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Interacting With the Food and Drug Administration on Complex Innovative Trial Designs for Drugs and Biological Products; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products.'' The guidance provides recommendations to sponsors and applicants on interacting with FDA on complex innovative trial design (CID)...
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Dry Eye: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Dry Eye: Developing Drugs for Treatment.'' The purpose of this draft guidance is to foster greater efficiency in drug development for this disease, which currently has few effective treatment options. The goal is to enhance...
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Controlled Correspondence Related to Generic Drug Development; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Controlled Correspondence Related to Generic Drug Development.'' This guidance provides information regarding the process by which generic drug manufacturers and related industry can submit controlled correspondence to FDA...
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Issuance of Priority Review Voucher; Rare Pediatric Disease Product
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain...
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Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Prohibited From Use in Animal Food or Feed
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information,...
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Agency Information Collection Activities; Proposed Collection; Comment Request; State Enforcement Notifications
The Food and Drug Administration (FDA, we, or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information,...
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Issuance of Priority Review Voucher; Rare Pediatric Disease Product
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain...
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Meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that a meeting is scheduled to be held for the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB). The meeting will be open to the public via webex and teleconference; a pre- registered...