Energy Policy and New Uses Office, Agriculture Department – Federal Register Recent Federal Regulation Documents
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Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on an information collection pertaining to the collection of tuberculosis-related information from United States Panel Physicians.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications
The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ``Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Analytical Procedures and Methods Validation for Drugs and Biologics; Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Analytical Procedures and Methods Validation for Drugs and Biologics.'' This guidance supersedes the draft of the same name that published on February 19, 2014, and replaces the 2000 draft guidance for industry on ``Analytical Procedures and Methods Validation'' and the 1987 FDA guidance for industry on ``Submitting Samples and Analytical Data for Methods Validation.'' This guidance discusses how to submit analytical procedures and methods validation data to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products.
Developmental Disabilities Program
This rule implements the Developmental Disabilities Assistance and Bill of Rights Act of 2000. The previous regulations were completed in 1997 before the current law was passed. The rule will align the regulations and current statute and will provide guidance to AIDD grantees.
Food Labeling: Revision of the Nutrition and Supplement Facts Labels; Reopening of the Comment Period as to Specific Documents
The Food and Drug Administration (FDA or we) is reopening, as to specific documents, the comment period regarding our proposed rule to revise the Nutrition Facts and Supplement Facts labels. We are reopening the comment period for 60 days for the sole purpose of inviting public comments on two consumer studies being added to the administrative record. The consumer studies pertained to proposed changes to the Nutrition Facts label formats.
Food Labeling: Revision of the Nutrition and Supplement Facts Labels; Supplemental Proposed Rule To Solicit Comment on Limited Additional Provisions
The Food and Drug Administration (FDA or we) is revising certain provisions of the proposed rule, issued in March 2014, that would amend FDA's labeling regulations for conventional foods and dietary supplements to provide updated nutrition information on the Nutrition Facts and Supplement Facts labels to assist consumers in maintaining healthy dietary practices (``the NFL/SFL proposed rule''). We are proposing text for the footnotes to be used on the Nutrition Facts label. We are taking this action after completing our consumer research in which we tested various footnote text options for the label. We are also proposing to establish a Daily Reference Value (DRV) of 10 percent of total energy intake from added sugars, proposing to require the declaration of the percent Daily Value (DV) for added sugars on the label, and are providing additional rationale for the declaration of added sugars on the label. We are taking these actions based, in part, on the science underlying a new report released by the 2015 Dietary Guidelines Advisory Committee.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: The necessity and utility of the proposed information collection for the proper performance of the agency's functions; the accuracy of the estimated burden; ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Advisory Committee on Infant Mortality: Change in Meeting Dates
Health Resources and Services Administration is issuing this notice to change the meeting dates for the Notice is hereby given of a change in the meeting of the Secretary's Advisory Committee on Infant Mortality (SACIM). The meeting was originally scheduled for July 13-14, 2015 and was published in the Federal Register on June 26, 2015, 80 FR 123 (page 36826).
Privacy Act of 1974, as Amended by Public Law 100-503; Computer Matching Program
In compliance with the Privacy Act of 1974, as amended by Public Law 100-503, the Computer Matching and Privacy Protection Act of 1988, ACF is publishing a notice of a computer matching program. The purpose of this computer match is to identify specific individuals who receive benefits from the Department of Veterans Affairs (VA) and also receive payments pursuant to various benefit programs administered by both the Department of Health and Human Services (HHS) and the Department of Agriculture. ACF will facilitate this program on behalf of SPAAs that participate in PARIS for verification of continued eligibility for public assistance. The match will utilize VA and SPAA records.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection entitled ``Screening and Counseling of Male EVD Survivors to reduce Risk of Sexually Transmitting Ebola Virus''. This activity will collect information on participants' laboratory results and sexual activity prior to and during participation in the screening program.
Third-Party Auditor/Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and FDA staff entitled ``Third-Party Auditor/Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards.'' The draft guidance, when finalized, will contain FDA recommendations on third-party auditor/ certification body qualifications for accreditation to conduct food safety audits and to issue food and/or facility certifications under an FDA program required by the FDA Food Safety Modernization Act (FSMA).
User Fee Program To Provide for Accreditation of Third-Party Auditors/Certification Bodies To Conduct Food Safety Audits and To Issue Certifications
The Food and Drug Administration (FDA, the Agency, or we) is issuing this proposed rule to amend the proposed rule, ``Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications'' (Accreditation of Third-Party Auditors proposed rule) and to propose to establish a reimbursement (user fee) program to assess fees and require reimbursement for the work performed to establish and administer the system for the Accreditation of Third-Party Auditors under the FDA Food Safety Modernization Act (FSMA).
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Petition To Request an Exemption From 100 Percent Identity Testing of Dietary Ingredients: CGMP in Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements
The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ``Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients: CGMP in Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Julia Bitzegeio, Ph.D., Aaron Diamond AIDS Research Center: Based on the Respondent's admission, an assessment conducted by the Aaron Diamond AIDS Research Center (ADARC), and analysis conducted by ORI in its oversight review, ORI found that Dr. Julia Bitzegeio, former Postdoctoral Fellow, ADARC, engaged in research misconduct in research supported by National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), grants R01 AI078788, R21 AI093255, and R37 AI064003. ORI found that Respondent engaged in research misconduct by falsifying and/or fabricating data that were included in one (1) publication, two (2) unfunded grant applications, and one (1) unpublished manuscript: Journal of Virology 87:3549-3560, 2013 (hereafter referred to as ``JVI 2013'').
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reclassification Petitions for Medical Devices; Correction
The Food and Drug Administration is correcting a notice entitled ``Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reclassification Petitions for Medical Devices'' that appeared in the Federal Register of June 12, 2015 (80 FR 33524). The document announced 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. The document inadvertently contained inaccurate information regarding communications with industry, including inaccurate contact information. This document corrects that error.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health Claim
The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ``Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health Claim'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Intent To Review a Study Data Reviewer's Guide Template
The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), is establishing a public docket to collect comments related to a proposed Study Data Reviewer's Guide (SDRG) template. As part of FDA's ongoing collaboration with the Pharmaceutical Users Software Exchange (PhUSE), an independent, non- profit consortium addressing computational science issues, a PhUSE working group developed the PhUSE SRDG template. The purpose of this review is to evaluate the template and determine whether FDA will recommend its use either as is, or in a modified form, for regulatory submissions of study data. FDA is seeking public comment on the use of the PhUSE SDRG template for regulatory submissions.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Sun Protection Factor Labeling and Testing Requirements and Drug Facts Labeling for Over-the-Counter Sunscreen Drug Products
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.
Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry; Availability; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of June 30, 2015 (80 FR 37273). The document announced the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The document was published with an incorrect table title and contents. This document corrects those errors.
Gastroparesis: Clinical Evaluation of 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 ``Gastroparesis: Clinical Evaluation of Drugs for Treatment.'' This draft guidance is intended to provide FDA's current thinking regarding clinical trial design and clinical endpoint assessments to support development of drugs for the treatment of diabetic and idiopathic gastroparesis.
Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Meeting on American Indian/Alaska Native Lesbian, Gay, Bisexual, and Transgender Health Issues
The Indian Health Service (IHS) is seeking broad public input as it begins efforts to advance and promote the health needs of the American Indian/Alaska Native (AI/AN) Lesbian, Gay, Bisexual, and Transgender (LGBT) community.
Division of Behavioral Health, Office of Clinical and Preventive Services; Methamphetamine and Suicide Prevention Initiative; Correction
The Indian Health Service published a document in the Federal Register on July 8, 2015, for the FY 2015 Methamphetamine and Suicide Prevention Initiative. The notice contained four incorrect broad objectives for Purpose Area #2.
Performance Standards for Ionizing Radiation Emitting Products; Fluoroscopic Equipment; Correction; Confirmation of Effective Date
The Food and Drug Administration (FDA or we) is confirming the effective date of August 26, 2015, for the direct final rule that appeared in the Federal Register of April 13, 2015. The direct final rule amends a Federal performance standard for ionizing radiation to correct a drafting error regarding fluoroscopic equipment measurement. We are taking this action to ensure clarity and improve the accuracy of the regulations. This document confirms the effective date of the direct final rule.
Agency Information Collection Activities: Proposed Collection: Public Comment Request
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate below, or any other aspect of the ICR.
Agency Information Collection Activities: Proposed Collection: Public Comment Request
In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
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