Department of Health and Human Services 2014 – Federal Register Recent Federal Regulation Documents

Results 51 - 100 of 3,623
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: 2014-30149
Type: Notice
Date: 2014-12-24
Agency: Food and Drug Administration, Department of Health and Human Services
Food Additives Permitted for Direct Addition to Food for Human Consumption; Advantame
Document Number: 2014-30144
Type: Rule
Date: 2014-12-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is responding to objections we received on the final rule that amended the food additive regulations to provide for the safe use of advantame as a non-nutritive sweetener and flavor enhancer in foods generally, except in meat and poultry. After reviewing the objections to the final rule, we have concluded that they do not provide a basis for modifying or revoking the regulation. We are also confirming the effective date of May 21, 2014, for the final rule.
Human Cells, Tissues, and Cellular and Tissue-Based Products From Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry; Availability
Document Number: 2014-30142
Type: Proposed Rule
Date: 2014-12-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry'' dated December 2014. The draft guidance document provides sponsors, clinicians, and other establishments that manufacture and use adipose tissue, with recommendations for complying with the regulatory framework for HCT/Ps. For purposes of applying the HCT/P regulatory framework, FDA considers connective tissue, including adipose tissue, to be a structural tissue. This draft guidance is not final nor is it in effect at this time.
Medical Device Classification Procedures; Reclassification Petition: Content and Form; Technical Amendment
Document Number: 2014-30141
Type: Rule
Date: 2014-12-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending its regulations for petitioning for device reclassification to update mailing addresses for the petitions. This action is being taken to improve the accuracy of the regulations.
Bioequivalence Recommendations for Methylphenidate Hydrochloride Extended-Release Oral Suspension; Draft Guidance for Industry; Availability
Document Number: 2014-30109
Type: Notice
Date: 2014-12-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Bioequivalence Recommendations for Methylphenidate Hydrochloride Extended-Release Oral Suspension.'' The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for methylphenidate hydrochloride (HCl) extended- release oral suspension.
Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Ebola Zaire Virus; Availability
Document Number: 2014-30108
Type: Notice
Date: 2014-12-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the issuance of two Emergency Use Authorizations (EUAs) (the Authorizations) for two in vitro diagnostic devices for detection of the Ebola Zaire virus. FDA is issuing these Authorizations under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by the Centers for Disease Control and Prevention (CDC). The Authorizations contain, among other things, conditions on the emergency use of the authorized in vitro diagnostic devices. The Authorizations follow the September 22, 2006, determination by then-Secretary of the Department of Homeland Security (DHS), Michael Chertoff, that the Ebola virus presents a material threat against the U.S. population sufficient to affect national security. On the basis of such determination, the Secretary of Health and Human Services (HHS) declared on August 5, 2014, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of Ebola virus subject to the terms of any authorization issued under the FD&C Act. The Authorizations, which include an explanation of the reasons for issuance, are reprinted in this document.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2014-30083
Type: Notice
Date: 2014-12-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2014-30027
Type: Notice
Date: 2014-12-24
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2014-30026
Type: Notice
Date: 2014-12-24
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Standards To Prevent, Detect, and Respond to Sexual Abuse and Sexual Harassment Involving Unaccompanied Children
Document Number: 2014-29984
Type: Rule
Date: 2014-12-24
Agency: Department of Health and Human Services, Administration for Children and Families
This IFR proposes standards and procedures to prevent, detect, and respond to sexual abuse and sexual harassment involving unaccompanied children (UCs) in ORR's care provider facilities.
Announcement of a Workshop and a Request for Public Comment on Questions Regarding Dietary Reference Intakes and Chronic Disease Endpoints
Document Number: 2014-29766
Type: Notice
Date: 2014-12-19
Agency: Department of Health and Human Services
The Dietary Reference Intakes (DRI) Committees of the U.S. and Canadian governments will hold a workshop entitled ``Options for Consideration of Chronic Disease Endpoints for Dietary Reference Intakes.'' The objective of the workshop is to critically evaluate key scientific issues involved in using chronic disease endpoints for setting DRIs and, in this context, to provide information for future decisions as to whether and/or how chronic disease endpoints can be incorporated into the setting of DRI values. In preparation for this meeting, the DRI Committees are asking for public comment on the set of questions that the meeting panelists will discuss.
Medicare and Medicaid Programs: Application from the Joint Commission for Continued CMS-Approval of its Hospice Accreditation Program
Document Number: 2014-29757
Type: Notice
Date: 2014-12-19
Agency: Department of Health and Human Services
This proposed notice with comment period acknowledges the receipt of an application from the Joint Commission for continued recognition as a national accrediting organization for hospices that wish to participate in the Medicare or Medicaid programs. A hospice that participates in Medicaid must also meet the Medicare conditions for participation as required under 42 CFR 488.6(b). The statute requires that within 60 days of receipt of an organization's complete application, we publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions
Document Number: 2014-29752
Type: Notice
Date: 2014-12-19
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2014-29741
Type: Notice
Date: 2014-12-19
Agency: Department of Health and Human Services
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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2014-29740
Type: Notice
Date: 2014-12-19
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2014-29739
Type: Notice
Date: 2014-12-19
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Minimizing Risk for Children's Toy Laser Products; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2014-29725
Type: Notice
Date: 2014-12-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Minimizing Risk for Children's Toy Laser Products.'' This guidance is intended to inform manufacturers of laser products, FDA headquarters and field personnel, and the public of the Center for Devices and Radiological Health's (CDRH) current thinking on the safety of children's toy laser products and to provide specific safety recommendations for the manufacture and labeling of children's toy laser products.
Public Meeting on Patient-Focused Drug Development for Breast Cancer; Request for Comments
Document Number: 2014-29721
Type: Notice
Date: 2014-12-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing a public meeting and an opportunity for public comment on patient- focused drug development for breast cancer. Patient-focused drug development is part of FDA's performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patient perspectives on the impact of breast cancer on daily life and patient views on treatment approaches.
Serious Drug-Induced Liver Injury: The Importance of Getting It Right: How To Measure and Interpret Drug-Induced Liver Injury Information and Make Correct Diagnoses; Public Conference; Request for Comments
Document Number: 2014-29720
Type: Notice
Date: 2014-12-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public conference entitled ``Serious Drug-Induced Liver Injury (DILI): The Importance of Getting It Right: How to Measure and Interpret DILI Information and Make Correct Diagnoses.'' This conference will be cosponsored with the Critical Path Institute (C-Path) and the Pharmaceutical Research and Manufacturers of America. The purpose of the public conference is to discuss, debate, and share views among stakeholders in the pharmaceutical industry, academia, health care providers, patient groups, and regulatory bodies on how best to detect and assess the severity, extent, and likelihood of drug causation of liver injury and dysfunction in people using drugs for any medical purpose.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2014-29715
Type: Notice
Date: 2014-12-19
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Federal Awarding Agency Regulatory Implementation of Office of Management and Budget's Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards
Document Number: 2014-28697
Type: Rule
Date: 2014-12-19
Agency: Agency for International Development, Agencies and Commissions, Department of the Interior, Department of Justice, Department of Labor, National Aeronautics and Space Administration, National Archives and Records Administration, National Science Foundation, Small Business Administration, Social Security Administration, Department of State, Department of Transportation, Department of Treasury, Department of Veterans Affairs, National Institute of Food and Agriculture, National Endowment for the Arts, Office of the Chief Financial Officer, National Endowment for the Humanities, Institute of Museum and Library Services, Department of Housing and Urban Development, Department of Homeland Security, Department of Agriculture, Commodity Credit Corporation, Farm Service Agency, Rural Business-Cooperative Service, Rural Housing Service, Rural Utilities Service, Department of Commerce, Corporation for National and Community Service, Department of Defense, Department of Education, Department of Energy, Environmental Protection Agency, Executive Office of the President, Management and Budget Office, National Drug Control Policy Office, Federal Emergency Management Agency, Department of Health and Human Services
This joint interim final rule implements for all Federal award-making agencies the final guidance Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (Uniform Guidance) published by the Office of Management and Budget (OMB) on December 26, 2013. This rule is necessary in order to incorporate into regulation and thus bring into effect the Uniform Guidance as required by OMB. Implementation of this guidance will reduce administrative burden and risk of waste, fraud, and abuse for the approximately $600 billion per year awarded in Federal financial assistance. The result will be more Federal dollars reprogrammed to support the mission, new entities able to compete and win awards, and ultimately a stronger framework to provide key services to American citizens and support the basic research that underpins the United States economy.
Caring for Our Children Basics; Comment Request
Document Number: 2014-29649
Type: Notice
Date: 2014-12-18
Agency: Department of Health and Human Services, Administration for Children and Families
As authorized by the 2014 Omnibus Act, ACF is requesting public comment on a voluntary set of minimum health and safety standards for early care and education settings titled, ``Caring for Our Children Basics.''
World Trade Center Health Program; Petition 006-Primary Biliary Cirrhosis; Finding of Insufficient Evidence
Document Number: 2014-29647
Type: Proposed Rule
Date: 2014-12-18
Agency: Department of Health and Human Services
On October 20, 2014, the Administrator of the World Trade Center (WTC) Health Program received a petition to add primary biliary cirrhosis (Petition 006) to the List of WTC-Related Health Conditions (List). The Administrator has not found sufficient scientific evidence to conduct an analysis of whether to add primary biliary cirrhosis to the List. Accordingly, the Administrator finds that insufficient evidence exists to request a recommendation of the WTC Health Program Scientific/Technical Advisory Committee (STAC), to publish a proposed rule, or to publish a determination not to publish a proposed rule.
Proposed Information Collection Activity; Comment Request
Document Number: 2014-29641
Type: Notice
Date: 2014-12-18
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2014-29627
Type: Notice
Date: 2014-12-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff on Meetings With the Office of Orphan Products Development
Document Number: 2014-29612
Type: Notice
Date: 2014-12-18
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics
Document Number: 2014-29611
Type: Notice
Date: 2014-12-18
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act; Availability
Document Number: 2014-29609
Type: Notice
Date: 2014-12-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Providing Regulatory Submissions in Electronic FormatSubmissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act.'' The guidance announced in this notice sets forth FDA's interpretation of the Food and Drug Administration Safety and Innovation Act (FDASIA), which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to require that certain submissions under the FD&C Act and the Public Health Service Act be submitted in electronic format, beginning no earlier than 24 months after issuance of a final version of a guidance document specifying the format for such electronic submissions. This guidance describes how FDA interprets and plans to implement the electronic submission requirements and finalizes the draft guidance that was issued on February 6, 2014.
Providing Regulatory Submissions in Electronic Format-Standardized Study Data; Guidance for Industry; Availability
Document Number: 2014-29608
Type: Notice
Date: 2014-12-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Providing Regulatory Submissions in Electronic FormatStandardized Study Data.'' The guidance announced in this document is being issued in accordance with the Food and Drug Administration Safety and Innovation Act (FDASIA), which amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to require that certain submissions under the FD&C Act and Public Health Service Act (PHS Act) be submitted in electronic format, beginning no earlier than 24 months after issuance of final guidance on that topic. The guidance describes how FDA plans to implement the requirements for the electronic submission of standardized study data contained in certain submissions under new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and investigational new drug applications (INDs). This finalizes the revised draft guidance that was issued on February 6, 2014.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry: Fast Track Drug Development Programs: Designation, Development, and Application Review
Document Number: 2014-29607
Type: Notice
Date: 2014-12-18
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2014-29573
Type: Notice
Date: 2014-12-18
Agency: Department of Health and Human Services, National Institutes of Health
Prospective Grant of Exclusive License: Multivalent Vaccines for Rabies Virus and Ebola and Marburg (Filoviruses)
Document Number: 2014-29572
Type: Notice
Date: 2014-12-18
Agency: Department of Health and Human Services, National Institutes of Health
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 404, that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of a an exclusive license to practice the following invention as embodied in the following patent applications: E-032-2011/0, Blaney et al., ``Multivalent Vaccines for Rabies Virus and Filoviruses'', U.S. Patent Application Number 61/439,046, filed on February 3, 2011, PCT Application Number PCT/US2012/23575, filed on February 2, 2012, U.S. Patent Application Number 13/983,545, filed on August 2, 2013, European Patent Application Number 12702953.6, filed on February 2, 2012, and Canadian Patent Application Number 2826594, filed on February 2, 2012, to Exxell BIO, Inc., having a place of business in Shoreview, Minnesota, United States of America. The patent rights in these inventions have been assigned to the United States of America and Thomas Jefferson University.
National Center for Complementary & Alternative Medicine; Notice of Meeting
Document Number: 2014-29571
Type: Notice
Date: 2014-12-18
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD); Notice of Meeting
Document Number: 2014-29570
Type: Notice
Date: 2014-12-18
Agency: Department of Health and Human Services, National Institutes of Health
Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products
Document Number: 2014-29522
Type: Proposed Rule
Date: 2014-12-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is proposing to amend its prescription drug and biological product labeling regulations to require electronic distribution of the prescribing information intended for health care professionals, which is currently distributed in paper form on or within the package from which a prescription drug or biological product is dispensed. FDA is also proposing that prescribing information intended for health care professionals will no longer be permitted to be distributed in paper form with the package from which a prescription drug or biological product is dispensed, except as provided by this regulation. We are proposing these actions to help ensure that the most current prescribing information is publicly accessible for the safe and effective use of human prescription drugs.
Statement of Organization, Functions and Delegations of Authority
Document Number: 2014-29576
Type: Notice
Date: 2014-12-17
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2014-29520
Type: Notice
Date: 2014-12-17
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2014-29505
Type: Notice
Date: 2014-12-17
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Agency Information Collection Activities: Proposed Collection: Public Comment Request
Document Number: 2014-29504
Type: Notice
Date: 2014-12-17
Agency: Department of Health and Human Services, Health Resources and Services Administration
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.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2014-29503
Type: Notice
Date: 2014-12-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Office for State, Tribal, Local and Territorial Support (OSTLTS) Meeting
Document Number: 2014-29489
Type: Notice
Date: 2014-12-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2014-29488
Type: Notice
Date: 2014-12-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC); Meeting
Document Number: 2014-29487
Type: Notice
Date: 2014-12-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection; Comment Request; Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice and Retail Food Stores Facility Types
Document Number: 2014-29478
Type: Notice
Date: 2014-12-17
Agency: Food and Drug Administration, Department of Health and Human Services
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a survey entitled ``Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice and Retail Food Stores Facility Types (2015-2025).''
Submission for OMB Review; 30-Day comment request; Generic Clearance for Satisfaction Surveys of Customers (CSR)
Document Number: 2014-29460
Type: Notice
Date: 2014-12-16
Agency: Department of Health and Human Services, National Institutes of Health
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on August 21, 2014, page 49523 and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to request an additional 30 days for public comment and reinstatement without change. The Center for Scientific Review (CSR), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 31, 2014, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer.
Submission for OMB Review; Comment Request
Document Number: 2014-29439
Type: Notice
Date: 2014-12-16
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Records and Reports Concerning Experiences With Approved New Animal Drugs: Adverse Event Reports
Document Number: 2014-29426
Type: Notice
Date: 2014-12-16
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requirements for Submission of Bioequivalence Data
Document Number: 2014-29425
Type: Notice
Date: 2014-12-16
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Privacy Act of 1974; Report of a New System of Records; Food and Drug Administration Commissioning of State and Local Officials; Correction
Document Number: 2014-29424
Type: Notice
Date: 2014-12-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of December 8, 2014. The document misstated the effective date of the new system of records. This notice corrects that error.
Submission for OMB Review; Comment Request
Document Number: 2014-29423
Type: Notice
Date: 2014-12-16
Agency: Department of Health and Human Services, Administration for Children and Families