Department of Health and Human Services June 26, 2014 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recordkeeping and Records Access Requirements for Food Facilities
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
This document corrects a notice that was published in the Federal Register on June 6, 2014 (79 FR 32737-32738). The time and date should read as follows: Time and Date: 9:30 a.m.-3:30 p.m., June 19, 2014 (Closed). For Further Information Contact: Gwendolyn H. Cattledge, Ph.D., M.S.E.H., F.A.C.E., Deputy Associate Director for Science, National Center for Injury Prevention and Control, CDC, 4770 Buford Highway NE., Mailstop F63, Atlanta, Georgia 30341, Telephone: (770) 488-4655, GXC8@cdc.gov. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
This document corrects a notice that was published in the Federal Register on June 12, 2014 (79 FR 33755). This meeting is cancelled in its entirety. Contact Person for More Information: M. Chris Langub, Ph.D., Scientific Review Officer, CDC, 4770 Buford Highway NE., Mailstop F-80, Atlanta, Georgia 30341, Telephone: (770) 488-3585, EEO6@cdc.gov. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.
Small Entity Compliance Guide: Gluten-Free Labeling of Foods; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Gluten-Free Labeling of FoodsSmall Entity Compliance Guide.'' The small entity compliance guide (SECG) is being issued for a final rule published in the Federal Register of August 5, 2013, and is intended to set forth in plain language the requirements of the regulation and to help small businesses understand the regulation.
Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements for Submission of Bioequivalence Data
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the requirement for an abbreviated new drug application (ANDA) applicant to submit data from all bioequivalence (BE) studies the applicant conducts on a drug product formulation submitted for approval.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Importer's Entry Notice
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Importer's Entry Notice'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance: Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with the Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program.
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