Department of Health and Human Services 2014 – Federal Register Recent Federal Regulation Documents
Results 401 - 600 of 3,623
Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals
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 current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.
Armando Santos: Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Armando Santos from providing services in any capacity to a person that has an approved or pending drug product application for a period of 12 years. FDA bases this order on a finding that Mr. Santos was convicted of seven felony counts under Federal law for conduct involving health care fraud, conspiracy to commit health care fraud, and false statements related to health care matters and that this pattern of conduct is sufficient to find that there is reason to believe he may violate requirements under the FD&C Act relating to drug products. Mr. Santos was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Mr. Santos failed to respond. Mr. Santos's failure to respond constitutes a waiver of his right to a hearing concerning this action.
Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Physician-Owned Hospitals: Data Sources for Expansion Exception; Physician Certification of Inpatient Hospital Services; Medicare Advantage Organizations and Part D Sponsors: CMS-Identified Overpayments Associated with Submitted Payment Data
This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2015 to implement applicable statutory requirements and changes arising from our continuing experience with these systems. In this final rule with comment period, we describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, this final rule with comment period updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program. In this document, we also are making changes to the data sources permitted for expansion requests for physician-owned hospitals under the physician self-referral regulations; changes to the underlying authority for the requirement of an admission order for all hospital inpatient admissions and changes to require physician certification for hospital inpatient admissions only for long-stay cases and outlier cases; and changes to establish a formal process, including a three- level appeals process, to recoup overpayments that result from the submission of erroneous payment data by Medicare Advantage (MA) organizations and Part D sponsors in the limited circumstances in which the organization or sponsor fails to correct these data.
Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB)
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. 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. We are, however, requesting an emergency review of the information collection referenced below. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, we have submitted to the Office of Management and Budget (OMB) the following requirements for emergency review. This is necessary to ensure compliance with an initiative of the Administration. We are requesting an emergency review under 5 CFR Part 1320(a)(2)(i) because public harm is reasonably likely to result if the normal clearance procedures are followed. We are seeking emergency approval for modifications to the information collection request (ICR) currently approved under Office of Management and Budget (OMB) control number 0938-1119 in order to collection additional information during the 2015 open enrollment periods from the 14 operational SBMs (including Washington, DC) to enhance the agency's understanding of the demographic makeup of the citizens enrolling in the various health plans as well as the affordability of those plans. Existing collections gather information from the grant awardee to ensure the CMS is able to conduct their statutory oversight responsibilities. The revision to the weekly reporting requirement is necessary to obtain more accurate and consistent enrollment data during the upcoming Open Enrollment Period which begins November 15, 2014. The immediate need for this revision is due to the State-Based Marketplaces (SBM) maturing business processes and the requirement for more precise reporting of comparison data between the first and second years of ACA implementation. The changes to the revised format of the Weekly Report have been presented to all participating states. CMS is requesting an emergency modification to the weekly reporting template in order to capture certain demographic data and information on new versus re-enrolled individuals in accordance with uniform definitions so as not to produce misleading results.
Clinical Laboratory Improvement Amendments (CLIA); Fecal Occult Blood (FOB) Testing
This proposed rule would amend the Clinical Laboratory Improvement Amendments (CLIA) regulations to clarify that the waived test categorization applies only to non-automated fecal occult blood tests. In addition, the proposed rule would remove the hemoglobin by copper sulfate method from the list of waived tests if commenters confirm that the method is no longer used.
Proposed Adoption of Administration for Native Americans Program Policies and Procedures
The Administration for Native Americans (ANA) invites public comment pursuant to Section 814 of the Native American Programs Act of 1974 (NAPA), as amended, which requires ANA to provide members of the public with the opportunity to comment on proposed changes in interpretive rules, general statements of policy, and rules of agency procedure or practice that affect programs, projects, and activities authorized under the NAPA, and to give notice of the final adoption of such changes at least 30 days before the changes become effective. In accordance with notice requirements of NAPA, ANA herein describes its proposal to fund projects, beginning in Fiscal Year (FY) 2015, under Alaska-Specific SEDS.
Determination Concerning a Petition to Add a Class of Employees to the Special Exposure Cohort
HHS gives notice of a determination concerning a petition to add a class of employees from the Simonds Saw and Steel Company in Lockport, New York, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA).
The Iams Company; Filing of Food Additive Petition (Animal Use)
The Food and Drug Administration (FDA) is announcing that The Iams Company has filed a petition proposing that the food additive regulations be amended to provide for the safe use of a Salmonella- specific bacteriophage preparation as a food additive as an antimicrobial processing aid to reduce Salmonella in the production of dry dog and cat pet food.
Specification of the Unique Facility Identifier System for Drug Establishment Registration; Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration.'' This guidance specifies the UFI system for registration of domestic and foreign drug establishments. The guidance addresses provisions set forth in the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). This guidance finalizes the draft guidance issued on September 6, 2013.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, Grants.gov (EGOV), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for reinstatement of a previously-approved information collection assigned OMB control number 4040-0016SF-429 Real Property Status Report, which expired on July 31, 2014. The ICR also requests categorizing the form as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. Prior to submitting that ICR to OMB, EGOV 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 section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, Grants.gov (EGOV), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for issuance of a new expiration date of a previously-approved information collection assigned OMB control number 4040-0014-SF-425 Federal Financial Report, which expires on February 28, 2015. The ICR also requests categorizing the form as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. Prior to submitting that ICR to OMB, EGOV 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 section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, Grants.gov (EGOV), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for reinstatement of a previously-approved information collection assigned OMB control number 4040-0013SF-LLL Disclosure of Lobbying Activities, which expired on December 31, 2013. The ICR also requests categorizing the form as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. Prior to submitting that ICR to OMB, EGOV 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 section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, Grants.gov (EGOV), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for reinstatement of a previously-approved information collection assigned OMB control number 4040-0012SF-270: Request for Advance or Reimbursement, which expired on October 31, 2013. The ICR also requests categorizing the form as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. Prior to submitting that ICR to OMB, EGOV 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 section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, Grants.gov (EGOV), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for reinstatement of a previously-approved information collection assigned OMB control number 4040-0011SF-271 Outlay Report and Request for Reimbursement for Construction Programs, which expired on October 31, 2013. The ICR also requests categorizing the form as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. Prior to submitting that ICR to OMB, EGOV 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 section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Electronic Government Office (EGOV), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is to reinstate the use of the previously approved information collection, Project Abstract Summary, assigned OMB control number 0980-0204 which expired on 11/30/2011, and to reinstate this information collection to 4040-0010 with a 3 year clearance. The ICR also requests categorizing the form as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. Prior to submitting that ICR to OMB, EGOV 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 section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, Grants.gov (EGOV), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for a 3-year renewal of a previously approved information collection assigned OMB control number 4040-0008SF-424 C Budget Information for Construction Programs, which expired on June 30, 2014. The ICR also requests categorizing the form as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. Prior to submitting that ICR to OMB, EGOV 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 section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, Grants.gov (EGOV), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for a 3 year renewal of a previously-approved information collection assigned OMB control number 4040-0006-SF-424 D Assurances for Construction Programs, which expired on June 30, 2014. The ICR also requests categorizing the form as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. Prior to submitting that ICR to OMB, EGOV 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 section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, Grants.gov (EGOV), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for a 3 year renewal of a previously-approved information collection assigned OMB control number 4040-0007SF-424 B Assurances for Non-Construction Programs, which expired on June 30, 2014. The ICR also requests categorizing the form as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. Prior to submitting that ICR to OMB, EGOV 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 section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, Grants.gov (EGOV), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for a 3 year renewal of a previously-approved information collection assigned OMB control number 4040-0006SF-424 A Budget Information for Non-Construction Programs, which expired on June 30, 2014. The ICR also requests categorizing the form as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. Prior to submitting that ICR to OMB, EGOV seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. Additionally, Grants.gov requests a change to the Application Instructions for this form. Application instructions are available from the Grants.gov program management office. The point of contact is Ed Calimag (ed.calimag@hhs.gov).
Agency Information Collection Activities; Proposed Collection; Public Comment Request
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, Grants.gov (EGOV), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for reinstatement of a previously-approved information collection assigned OMB control number 4040-0003SF424 Short Organizational, which expired on July 30, 2011. The ICR also requests categorizing the form as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. Prior to submitting that ICR to OMB, EGOV 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 section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, Grants.gov (EGOV), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for reinstatement of a previously-approved information collection assigned OMB control number 4040-0002SF424 Mandatory, which expired on May 31, 2014. The ICR also requests categorizing the form as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. Prior to submitting that ICR to OMB, EGOV seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
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; Proposed Collection; Comment Request; Appeals of Science-Based Decisions Above the Division Level at the Center for Veterinary Medicine
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 information collection requirements for appeals of science-based decisions above the division level at the Center for Veterinary Medicine (CVM).
Bioequivalence Recommendations for CONCERTA (Methylphenidate Hydrochloride) Extended-Release Tablets; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Bioequivalence Recommendations for CONCERTA (methylphenidate hydrochloride) Extended- Release Tablets.'' The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) that reference the listed drug CONCERTA (methylphenidate hydrochloride (HCl)) extended-release tablets (new drug application (NDA) 021121). The draft guidance is a revised version of a previously issued draft guidance on the same subject.
Medicare Program; End-Stage Renal Disease Prospective Payment System, Quality Incentive Program, and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies
This final rule will update and make revisions to the End- Stage Renal Disease (ESRD) prospective payment system (PPS) for calendar year (CY) 2015. This rule also finalizes requirements for the ESRD quality incentive program (QIP), including for payment years (PYs) 2017 and 2018. This rule will also make a technical correction to remove outdated terms and definitions. In addition, this final rule sets forth the methodology for adjusting Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) fee schedule payment amounts using information from the Medicare DMEPOS Competitive Bidding Program (CBP); makes alternative payment rules for certain DME under the Medicare DMEPOS CBP; clarifies the statutory Medicare hearing aid coverage exclusion and specifies devices not subject to the hearing aid exclusion; will not update the definition of minimal self-adjustment; clarifies the Change of Ownership (CHOW) and provides for an exception to the current requirements; revises the appeal provisions for termination of a CBP contract, including the beneficiary notification requirement under the Medicare DMEPOS CBP, and makes a technical change to the regulation related to the conditions for awarding contracts for furnishing infusion drugs under the Medicare DMEPOS CBP.
Medicare and Medicaid Programs; CY 2015 Home Health Prospective Payment System Rate Update; Home Health Quality Reporting Requirements; and Survey and Enforcement Requirements for Home Health Agencies
This final rule updates Home Health Prospective Payment System (HH PPS) rates, including the national, standardized 60-day episode payment rates, the national per-visit rates, and the non-routine medical supply (NRS) conversion factor under the Medicare prospective payment system for home health agencies (HHAs), effective for episodes ending on or after January 1, 2015. As required by the Affordable Care Act, this rule implements the second year of the four-year phase-in of the rebasing adjustments to the HH PPS payment rates. This rule provides information on our efforts to monitor the potential impacts of the rebasing adjustments and the Affordable Care Act mandated face-to- face encounter requirement. This rule also implements: Changes to simplify the face-to-face encounter regulatory requirements; changes to the HH PPS case-mix weights; changes to the home health quality reporting program requirements; changes to simplify the therapy reassessment timeframes; a revision to the Speech-Language Pathology (SLP) personnel qualifications; minor technical regulations text changes; and limitations on the reviewability of the civil monetary penalty provisions. Finally, this rule also discusses Medicare coverage of insulin injections under the HH PPS, the delay in the implementation of the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM), and a HH value-based purchasing (HH VBP) model.
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the General Atomics facility in La Jolla, California, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.
Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Applications
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 regulations under which the clinical investigation of the safety and effectiveness of unapproved new drugs and biological products can be conducted.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers; Correction
The Food and Drug Administration (FDA or we) is correcting a notice that appeared in the Federal Register of August 14, 2014. The notice announced that a proposed collection of information had been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. In this document, we correct some errors that appeared in the notice.
Announcement of the Award of a Single-Source Program Expansion Supplement Grant to Child Trends, Inc., in Bethesda, MD
The Administration for Children and Families (ACF), Office of Planning, Research and Evaluation (OPRE) announces the award of a single-source expansion supplement award in the amount of $120,000 to Child Trends, Inc., in Bethesda, MD, to support activities that will provide research-based information to improve understanding of how to promote the economic and social well-being of underserved and under- represented populations.
Centers for Disease Control and Prevention (CDC)/Health Resources and Services Administration (HRSA) Advisory Committee on HIV, Viral Hepatitis, and Sexually Transmitted Disease (STD) Prevention and Treatment
The Health Resources and Services Administration published a notice in the Federal Register, FR 2014-25199 (October 23, 2014), announcing the meeting for the Centers for Disease Control and Prevention (CDC)/Health Resources and Services Administration (HRSA) Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment. The action is to provide correction to the virtual meeting audio access code. Correction: In the Federal Register, FR 2014-25199 (October 23, 2014), please make the following corrections: Join the meeting by: 1. (Audio Portion) Calling the Toll free Phone Number 1-888-942- 8515 and providing the Participant Pass Code 9582370, and 2. (Visual Portion) Connecting to the Advisory Committee Adobe Connect Pro Meeting using the following URL: https:// hrsa.connectsolutions.com/cdchrsa_advcmt/.
Medicare Program; Administrative Law Judge Hearing Program for Medicare Claim Appeals
This request for information solicits suggestions for addressing the substantial growth in the number of requests for hearing being filed with the Office of Medicare Hearings and Appeals, and backlog of pending cases.
Food and Drug Administration Activities for Patient Participation in Medical Product Discussions; Establishment of a Public Docket
The Food and Drug Administration (FDA) is announcing the establishment of a public docket for comments on FDA activities performed under the Food and Drug Administration Safety and Innovation Act (FDASIA), Patient Participation in Medical Product Discussions. This notice announces FDA's intent to gather input from stakeholders on strategies to obtain the views of patients during the medical product development process and ways to consider patients' perspectives during regulatory discussions. This notice provides background on ongoing patient engagement activities, so that stakeholders can consider both current and new activities that involve patient participation and perspectives during medical product regulatory discussions.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Safety Survey
The Food and Drug Administration (FDA or we) 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; Extralabel Drug Use in Animals
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 reporting requirements associated with extralabel drug use in animals.
Agency Information Collection Activities; Proposed Collection; Comment Request; Substantiation for Dietary Supplement Claims Made Under the Federal Food, Drug, and Cosmetic Act
The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on our proposed collection of certain information. 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 invites comments on the information collection provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and the guidance entitled ``Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act.''
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Testing Communications on Food and Drug Administration-Regulated Products Used in Animals
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 on Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices
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.
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). A notice listing all currently HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// beta.samhsa.gov/workplace.
World Trade Center Health Program; Petition 005-Acoustic Neuroma; Finding of Insufficient Evidence
On September 2, 2014, the Administrator of the World Trade Center (WTC) Health Program received a petition to add acoustic neuroma (Petition 005) 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 acoustic neuroma 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.
Agency Information Collection Activities: Proposed Collection; 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 (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
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.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for reinstatement with change of a previously-approved information collection assigned OMB control number 0955-0013 which expired on July 31, 2014, and for additional information collection requirements found at 45 CFR 170.523(f)(8) and 170.540(c). Prior to submitting the ICR to OMB, OS seeks comments from the public regarding the burden estimate below or any other aspect of the ICR.
Medicare Program; Approval of Request for an Exception to the Prohibition on Expansion of Facility Capacity Under the Hospital Ownership and Rural Provider Exceptions to the Physician Self-Referral Prohibition
This final notice announces our decision to approve the request from Lake Pointe Medical Center for an exception to the prohibition against expansion of facility capacity.
Privacy Act of 1974; Report of Modified System of Records
In accordance with the requirements of the Privacy Act of 1974, we are proposing to modify an existing SOR titled, ``Chronic Condition Data Repository (CCDR), System No. 09-70-0573'' last published at 71 FR 54495, September 15, 2006. The current name of the SOR, Chronic Condition Data Repository, was developed during the planning and development stages of the system. Upon the implementation and throughout the operations and maintenance stages of the system, the system has been referred to as the Chronic Condition Warehouse (CCW) in common usage and written references. In keeping with this current usage, we will modify the name of this SOR to read, and from this point forward will refer to the system as: ``Chronic Condition Warehouse (CCW).'' We propose to broaden the scope of the system to include data that can be easily linked, at the individual patient level, to all Medicare and Medicaid claims, enrollment and/or eligibility data, nursing home and home health assessments, and CMS beneficiary survey data. Accordingly, we are updating the Authority Section to include Title XVIII of the Social Security Act as amended (the Act); Section 1902(a)(6) of the Act; Section 1142(c)(6) of the Act; and Title IV of the Balanced Budget Act (Pub. L. 105-33). The Record Source Categories section will be modified to include data from two new systems of records: the CMS Encounter Data System, System No. 09-70-0506, and the National Death Index, System No. 09-20-0166. These modifications will make the CCW a more useful tool by which to support research, policy analysis, quality improvement activities, and demonstrations that attempt to foster a better understanding of how to improve the quality of life and contain the health care costs of the chronically ill. We propose to modify existing Routine Use Number 1, to limit disclosures only to contractors of CMS. We also propose to add two new routine uses. Specifically, we propose adding a routine use to permit disclosures to healthcare providers who seek patient information for use in care coordination and quality improvement activities as described at 45 CFR 164.506(c)(4). This routine use will be added as Routine Use Number 4. We also propose adding a routine use to support public or private Qualified Entities (QEs) that use Medicare claims data to evaluate the performance of providers of services and suppliers on measures of quality, efficiency, effectiveness, and resource use. This routine use will be added as routine use number 6. Finally, we are modifying the language in Routine Use Number 3 to include grantees of CMS administered grant programs and have made minor grammatical changes to Routine Use Number 10. These modifications will provide a better explanation as to the need for the routine use, and to clearly state CMS's intention when making disclosures of individually identifiable information contained in this system. We have provided background information about the modified system in the Supplementary Information section below. Although the Privacy Act requires only that the ``Routine Use'' section of the system of records notice be published for comment, CMS invites comments on all portions of this notice. See the Effective Dates section for information on the comment period.
Native American Programs
The Department of Health and Human Services, Administration for Children and Families, Administration for Native Americans (ANA) is seeking comments, data, and information from the public related to planned revisions and amendments to regulations implementing the Native American Programs Act of 1974 (the NAPA). ANA anticipates making revisions and amendments to update and revise procedures and policies involved in executing the requirements of 42 U.S.C. 2991b, 2991b-1, 2991b-2, 2991b-3, 2991d, 2991g, 2991h, 2992, and 2992b-1 (Section 803, 803A, 803B, 803C, 805, 809, 810, 811, and 814 of the NAPA) currently found in our regulations. ANA is interested in receiving feedback to this advance notice of proposed rulemaking (ANPRM) about potential means of streamlining applicable regulations, removing undue burdens, and clarifying procedures and policies related to accessing programs. We are also interested in receiving recommendations related to the activities of the Commissioner of the Administration for Native Americans as an advocate on behalf of Native Americans.
Notice of Intent To Award Ebola Response Outbreak Funding to Eligible Ministries of Health and Their Bona Fide Agents
This notice provides public announcement of CDC's intent to award Ebola appropriations to select Ministries of Health and their bona fide agents for response to the Ebola outbreak funding. This award was proposed in Fiscal Year (FY) 2015 under funding opportunity announcement GH14-1418, ``Protecting and Strengthening Public Health Impact, Systems, Capacity, and Security.'' This notice replaces the Notice of Intent to award Ebola Response outbreak funding to eligible Ministries of Health and their bona fide agents which was published on October 22, 2014 (79 FR 63126, October 22, 2014). CDC is correcting the application date, award dates, amount of funding available, and one of the points of contact. Catalogue of Federal Domestic Assistance Number (CFDA): 93.318.
Determination That TOPICORT (Desoximetasone) Cream and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Exports: Notification and Recordkeeping Requirements; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of October 14, 2014. The document announced that a proposed collection of information had been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. In this document, we correct some errors that appeared in the notice.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Participation in the Food and Drug Administration Commissioner's Fellowship Program
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.
Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Bijan Ahvazi, Ph.D., National Institutes of Health: Based on the report of an investigation conducted by the National Institutes of Health (NIH) and additional analysis by ORI in its oversight review, ORI found that Dr. Bijan Ahvazi, former Director of the Laboratory of X-ray Crystallography, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), NIH, engaged in research misconduct in research supported by the Intramural Program at NIAMS, NIH. ORI found that Respondent engaged in research misconduct by falsifying data related to or in the following published papers: 1. Ahvazi, B., Boeshans, K.M., Idler, W., Baxa, U., & Steinert, P.M. ``Structural basis for the coordinated regulation of transglutaminase 3 by guanine nucleotides and calcium/magnesium.'' J. Biol. Chem. 279(8):7180-92, 2004 Feb 20 (withdrawn) (hereinafter ``JBC 2004a'') 2. Ahvazi, B., Boeshans, K.M., & Steinert, P.M. ``Crystal structure of transglutaminase 3 in complex with BMP: Structural basis for nucleotide specificity.'' J. Biol. Chem. 279:26716-25, 2004 (withdrawn) (hereinafter ``JBC 2004b'') 3. Ahvazi, B., Boeshans, K.M., Idler, W.,& Cooper, A.J.L. ``Crystal structure of transglutaminase 3-cystamine complex: Binding of two cystamines to the nucleotide-binding pocket. M6:06060, Submitted to J. Biol. Chem., 2006 (rejected) (hereinafter ``JBC 2006''). Specifically, ORI finds that Respondent: 1. Falsely labeled Figure 3A in JBC 2004b representing an isothermal calorimetric titration (ITC) experiment using guanine monophosphate (GMP) and transglutaminase 3 (TGase 3) when the figure was actually a relabeled version of an unrelated experiment that Respondent previously published as Figure 1A in JBC 2004a. 2. falsified Figure 4B, Figure 4C, and Figure 6D in JBC 2004b and Figure 5E in JBC 2006, by altering the original data in the following ways to represent the desired experiment:
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.
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
This document corrects two notices that were published in the Federal Register on March 19, 2014, Volume 79, Number 53, pages 15349 and 15350. The times and dates should read as follows:
Sec. 223 Demonstration Programs To Improve Community Mental Health Services-Criteria for Certified Community Behavioral Health Clinics
The Substance Abuse and Mental Health Services Administration (SAMHSA) announces that it will hold a public listening session on Wednesday, November 12, 2014, to solicit information concerning the Criteria for Certified Community Behavioral Health Clinics (CCBHC) to participate in Demonstration Programs. The scheduled listening session provides an opportunity for SAMHSA to seek public input on the criteria development process. The scope of this session will be on the development of the Criteria only. The session will be held in Rockville, MD, to obtain direct input from stakeholders on the development of criteria for state certification of Community Behavioral Health Clinics.
Toxicological Principles for the Safety Assessment of Food Ingredients; Public Meeting on Updates and Safety and Risk Assessment Considerations; Request for Comments
The Food and Drug Administration (FDA or we) is announcing a public meeting to solicit comments on certain topics related to our guidance titled ``Toxicological Principles for the Safety Assessment of Food Ingredients,'' known less formally as the ``Redbook.'' The purpose of our public meeting is to invite public input into possibly expanding the scope of the Redbook to include chemical safety assessments for all products over which FDA's Center for Food Safety and Applied Nutrition (CFSAN) has statutory authority including regulatory contexts such as food additives, food contact substances, dietary supplement ingredients, food contaminants, and cosmetics. The Redbook would describe toxicological principles which apply across regulatory categories while still providing specific guidance for applying these principles within each particular context. The safety of foods containing microbial contaminants will continue to remain outside of the scope of the Redbook.
Request for Nominations on the Tobacco Products Scientific Advisory Committee
The Food and Drug Administration (FDA) is requesting that any small business tobacco manufacturing industry organizations interested in participating in the selection of nonvoting industry representatives to represent the interests of the small business tobacco manufacturing industry, to serve on the Tobacco Products Scientific Advisory Committee for the Center for Tobacco Products notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to be included in a pool of individuals to represent the interests of the small business tobacco manufacturing industry on the Tobacco Products Scientific Advisory Committee. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. This position may be filled on a rotating, sequential basis by representatives of different small business tobacco manufacturers based on areas of expertise relevant to the topics being considered by the Advisory Committee. Nominations will be accepted for current vacancies effective with this notice.
Meeting of the National Advisory Council for Healthcare Research and Quality
In accordance with section 10(a) of the Federal Advisory Committee Act, 5 U.S.C. App. 2, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Evaluation of the AHRQ Healthcare Horizon Scanning System.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104- 13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on August 12th, 2014 and allowed 60 days for public comment. AHRQ received no substantive comments. The purpose of this notice is to allow an additional 30 days for public comment.
Solicitation of Information and Recommendations for Revising OIG's Non-Binding Criteria for Implementing Permissive Exclusion Authority Under Section 1128(b)(7) of the Social Security Act
This document announces an extension of the public comment period for the OIG Federal Register notice published on July 11, 2014 (79 FR 40114). The notice solicited input from the public on revising the criteria used by OIG in implementing its permissive exclusion authority under Section 1128(b)(7) of the Social Security Act. Due to a technical problem, the public may have been unable to submit comments at https://www.regulations.gov during the comment period. Accordingly, we are extending the comment period to ensure that the public has an opportunity to provide input.
Best Practices for Communication Between the Food and Drug Administration and Investigational New Drug Sponsors During Drug Development; Request for Comments
The Food and Drug Administration (FDA) is announcing the establishment of a docket to receive suggestions, recommendations, and comments from interested parties, including academic institutions, regulated industry, and other interested organizations on best practices for communication between FDA and investigational new drug application (IND) sponsors during drug development. These comments will help FDA identify and ultimately establish best practices to be included in a draft guidance for industry and review staff.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Information Request Regarding pH of Smokeless Tobacco 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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Experience Reporting for Licensed Biological Products; and General Records
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.
Submission for OMB Review; 30-Day Comment Request: Generic Clearance for Satisfaction Surveys of Customers (CSR)
Under the provisions of Section 3507(a)(l)(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 allow an additional 30 days for public comment. 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.
New Animal Drugs; Alfaxalone; Dinoprost; Ivermectin and Clorsulon; Nitrofurazone; Trenbolone and Estradiol Benzoate; Trimethoprim and Sulfadiazine; Tylosin; Change of Sponsor
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during August 2014. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship of two NADAs and one ANADA, and to reflect a revised food safety warning.
Meeting of the Advisory Committee on Minority Health
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting conducted as a telephone conference call. This call will be open to the public. Preregistration is required for both public participation and comment. Any individual who wishes to participate in the call should email OMH-ACMH@hhs.gov by November 19, 2014. Instructions regarding participating in the call and how to provide verbal public comments will be given at the time of preregistration. Information about the meeting is available from the designated contact and will be posted on the Web site for the Office of Minority Health (OMH), www.minorityhealth.hhs.gov. Information about ACMH activities can be found on the OMH Web site under the heading About OMH.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below. The OS also welcomes comments on any other aspect of the ICR.
Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery
As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, Department of Health and Human Services has submitted a Generic Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery '' to OMB for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.).
Determination That DIAMOX (Acetazolamide) Intravenous, 500 Milligrams Base/Vial, and DIAMOX (Acetazolamide) Tablets, 125 Milligrams and 250 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that DIAMOX (acetazolamide) intravenous, 500 milligrams (mg) base/vial, and DIAMOX (acetazolamide) tablets, 125 mg and 250 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to these products, if all other legal and regulatory requirements are met.
Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care
The Department of Health and Human Services (HHS), through the Office for Human Research Protections (OHRP) is announcing the availability of a draft guidance for the research community entitled ``Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care.'' OHRP is specifically addressing what risks to subjects are presented by research evaluating or comparing risks associated with standards of care, and which of these risks are reasonably foreseeable and should be disclosed to prospective research subjects as part of their informed consent. OHRP is soliciting written comments from all interested parties, including, but not limited to IRB members, IRB staff, institutional officials, research institutions, investigators, research subject advocacy groups, ethicists, the regulated community, and the public at large. This draft guidance represents OHRP's current thinking on this topic. Certain treatments and procedures that are commonly used in health care for a given type of disease or condition have come to be known as ``standards of care.'' Multiple ``standards of care'' involving widely differing treatments and risks may be available for the same disease or medical condition. Where multiple ``standard of care'' options are available for a given disease or condition, the use of the term does not imply that the options will produce similar benefits or incur similar risks. Furthermore, patients may not find those options equally acceptable, nor do physicians always use them interchangeably. Importantly there is not necessarily a limit on how different the risks from two versions of a standard of care might be. For example, it may already be known that one of those versions imposes a significantly higher risk of death than the other. Adequate knowledge about the effectiveness and risks of standards of care and how these standards compare to each other is sometimes lacking. In recent years research studies designed to evaluate such treatments and procedures have become commonplace. These studies are often called ``comparative effectiveness research'' or ``standard of care research.'' As this type of research has become more common, so too have questions about how the HHS human subject protection regulations (45 CFR part 46) apply to such research. There is uncertainty in the research community about which risks of the research should be determined to be reasonably foreseeable risks of research and how they should be described to prospective subjects in the process of informed consent. OHRP's interpretation of the HHS research regulations has been that if people are being asked to undergo procedures in a research study that involve risks that they would not otherwise be exposed to, these are `research risks' that people must be informed about. Only in that way are they able to make a truly informed decision about whether they are willing to participate. For comparative effectiveness or standard of care research, OHRP's general position is that the reasonably foreseeable risks of research include already-identified risks of the standards of care being evaluated as a purpose of the research when the risks being evaluated are different from the risks subjects would be exposed to outside of the study. This guidance addresses these issues in the form of frequently asked questions. OHRP will consider comments received before issuing the final guidance document.
Extension of Deadline; Preschool Development Grants-Development Grants and Preschool Development Grants-Expansion Grants
On August 18, 2014, the Departments of Education and Health and Human Services published in the Federal Register (79 FR 48854 and 79 FR 48874) notices inviting applications for new awards for fiscal year 2014 for the Preschool Development GrantsDevelopment and Preschool Development GrantsExpansion Grants programs. The notices established October 14, 2014, as the deadline date for eligible applicants to apply for funding under the programs. On October 9, 2014, the Departments published in the Federal Register (79 FR 61065) a notice extending the deadline for submission to October 15, 2014, after learning that the Grants.gov Web site would be unavailable to applicants on October 11-12, 2014. It appears that some applicants may have encountered technical difficulties in the submission of their applications on October 15, 2014. Therefore, we are extending, to October 24, 2014, the deadline for transmittal of applications.
Food and Drug Administration Food Safety Modernization Act; Public Meeting
The Food and Drug Administration (FDA) is announcing a public meeting to discuss proposed revisions to four rules originally proposed in 2013 to implement the FDA Food Safety Modernization Act (FSMA). In response to the comments received on these foundational FSMA proposed rules, FDA issued supplemental notices of proposed rulemaking that propose significant changes to four of the proposed rules including: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (Preventive Controls for Human Food); Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Safety); Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (Preventive Controls for Animal Food); and Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (Foreign Supplier Verification Programs). The purpose of the public meeting is to solicit oral stakeholder and public comments on the new content of the supplemental proposed rules and to inform the public about the rulemaking process (including how to submit comments, data, and other information to the rulemaking dockets), and to respond to questions about the supplemental proposed rules.
Basic Health Program; Federal Funding Methodology for Program Year 2016
This document provides the methodology and data sources necessary to determine federal payment amounts made in program year 2016 to states that elect to establish a Basic Health Program under the Affordable Care Act to offer health benefits coverage to low-income individuals otherwise eligible to purchase coverage through Affordable Insurance Exchanges.
Notice of Intent To Award Ebola Response Outbreak Funding to African Field Epidemiology Network (AFENET)
This notice provides public announcement of CDC's intent to award Ebola appropriations to AFENET for response to the Ebola outbreak funding. This award was proposed in Fiscal Year (FY) 2015 under funding opportunity announcement GH10-1006 Strengthening the Development of Applied Epidemiology and Sustainable Public Health Capacity through Collaboration, Program Development and Implementation, Communication and Information Sharing.''
Same Surgical Procedure Exception Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Same Surgical Procedure Exception Questions and Answers Regarding the Scope of the Exception'' dated October 2014. The draft guidance document is intended for tissue establishments and healthcare professionals and discusses one of the exceptions for establishments from certain regulatory requirements.
National Vaccine Injury Compensation Program; List of Petitions Received
The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
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.
Renewal of Charters for Certain Federal Advisory Committees
As stipulated by the Federal Advisory Committee Act, as amended (5 U.S.C. App), the U.S. Department of Health and Human Services (HHS) is hereby announcing that the charters have been renewed for the following federal advisory committees for which the Office of the Assistant Secretary for Health provides management support: Chronic Fatigue Syndrome Advisory Committee (CFSAC); President's Council on Fitness, Sports, and Nutrition (PCFSN); Secretary's Advisory Committee on Human Research Protections (SACHRP); and Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA). Functioning as federal advisory committees, these committees are governed by the provisions of the Federal Advisory Committee Act (FACA). Under FACA, it is stipulated that the charter for a federal advisory committee must be renewed every two years in order for the committee to continue to operate.
Child Support Enforcement Program; Report to Congress
The Department of Health and Human Services, Administration for Children and Families, Office of Child Support Enforcement requests public comments to inform its upcoming Report to Congress. The Report to Congress (``Report'') is required to be submitted no later than June 30, 2015 under Title III, Section 305 of H.R. 4980 (Pub. L. 113-183), Preventing Sex Trafficking and Strengthening Families Act of 2014. The legislation was signed into law on September 29, 2014. This Request for Information offers the opportunity for interested individuals and organizations to provide input on specific Report requirements or other information that would be valuable to the Report development.
Medicare Program; Appellant Forum Regarding the Administrative Law Judge Hearing Program for Medicare Claim Appeals
This notice announces the second Office of Medicare Hearings and Appeals (OMHA) Medicare Appellant Forum. The purpose of this event is to provide updates to OMHA appellants on the status of OMHA operations and to relay information on a number of OMHA and CMS initiatives designed to reduce the backlog in the processing of Medicare appeals at the OMHA level and lower levels of the administrative appeals process.
Notice of Intent To Award Ebola Response Outbreak Funding to Eligible Ministries of Health and Their Bona Fide Agents
This notice provides public announcement of CDC's intent to award Ebola appropriations to select Ministries of Health and their bona fide agents for response to the Ebola outbreak funding. This award was proposed in Fiscal Year (FY) 2015 under funding opportunity announcement GH14-1418, ``Protecting and Strengthening Public Health Impact, Systems, Capacity, and Security.''
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; State Petitions for Exemption From Preemption
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; Infant Formula Recall Regulations
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.
Colorcon, Inc.; Filing of Color Additive Petition
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Colorcon, Inc., proposing that the color additive regulations be amended to provide for the safe use of spirulina extract as a color additive in coating formulations applied to dietary supplement and drug tablets and capsules.
National Eye Institute Meeting
Pursuant to the NIH Reform Act of 2006 (42 U.S.C. 281(d)(4)), notice is hereby given that the National Eye Institute will host a meeting to enable public discussion of the Institute's proposal to rename its Division of Extramural Research to the Division of Extramural Science and establish a new Division of Extramural Activities. The proposal seeks to clearly delineate functions and streamline the services provided by adding focus to scientific programs and extramural operations. This proposed change aligns NEI with the structure of other NIH Institutes and Centers.
Medical Devices; Immunology and Microbiology Devices; Classification of Nucleic Acid-Based Devices for the Detection of Mycobacterium Tuberculosis Complex and the Genetic Mutations Associated With Antibiotic Resistance
The Food and Drug Administration (FDA) is classifying nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex (MTB-complex) and the genetic mutations associated with MTB-complex antibiotic resistance in respiratory specimens devices into class II (special controls). The Agency is classifying the device into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of the device.
Migraine: Developing Drugs for Acute Treatment; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Migraine: Developing Drugs for Acute Treatment.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs for the acute treatment of migraine. This guidance focuses on specific drug development and trial design issues that are unique to the study of drugs for the acute treatment of migraine. This guidance is intended to serve as a focus for continued discussions among the Division of Neurology Products, pharmaceutical sponsors, the academic community, and the public.
Guidance for Industry on Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection.'' The Food and Drug Administration Safety and Innovation Act (FDASIA) added a provision to the Food, Drug, and Cosmetic Act (the FD&C Act) concerning inspections that makes a drug adulterated. This guidance defines the types of actions, inaction, and circumstances that FDA considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection for the purposes of making a drug adulterated.
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