Department of Health and Human Services May 2013 – Federal Register Recent Federal Regulation Documents

Results 301 - 350 of 353
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2013-10530
Type: Notice
Date: 2013-05-03
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-10522
Type: Notice
Date: 2013-05-03
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Proposed Information Collection Activity; Comment Request
Document Number: 2013-10494
Type: Notice
Date: 2013-05-03
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Document Number: 2013-10491
Type: Notice
Date: 2013-05-03
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Document Number: 2013-10484
Type: Notice
Date: 2013-05-03
Agency: Department of Health and Human Services, Administration for Children and Families
National Institute on Aging; Notice of Closed Meetings
Document Number: 2013-10453
Type: Notice
Date: 2013-05-03
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meetings
Document Number: 2013-10452
Type: Notice
Date: 2013-05-03
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2013-10451
Type: Notice
Date: 2013-05-03
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2013-10450
Type: Notice
Date: 2013-05-03
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2013-10449
Type: Notice
Date: 2013-05-03
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental and Craniofacial Research; Notice of Closed Meetings
Document Number: 2013-10448
Type: Notice
Date: 2013-05-03
Agency: Department of Health and Human Services, National Institutes of Health
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2013-10435
Type: Notice
Date: 2013-05-03
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2013-10426
Type: Notice
Date: 2013-05-03
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2013-10424
Type: Notice
Date: 2013-05-03
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Medicare and Medicaid Programs: Application From the Accreditation Commission for Health Care for Continued CMS-Approval of Its Hospice Accreditation Program
Document Number: 2013-10421
Type: Notice
Date: 2013-05-03
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed notice acknowledges the receipt of an application from the Accreditation Commission for Health Care (ACHC) for continued recognition as a national accrediting organization for hospices that wish to participate in the Medicare or Medicaid programs.
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-January Through March 2013
Document Number: 2013-10106
Type: Notice
Date: 2013-05-03
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from January through March 2013, relating to the Medicare and Medicaid programs and other programs administered by CMS.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2013-10403
Type: Notice
Date: 2013-05-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: 2013-10394
Type: Notice
Date: 2013-05-02
Agency: Food and Drug Administration, Department of Health and Human Services
Submission of New Drug Application/Abbreviated New Drug Application Field Alert Reports: Notice of Form FDA 3331-Automated Pilot Program
Document Number: 2013-10379
Type: Notice
Date: 2013-05-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a pilot program to test an XML (extensible markup language)-enabled Adobe PDF form, Form FDA 3331Automated to submit new drug application (NDA) and abbreviated new drug application (ANDA) Field Alert Reports (FARs) as required by FDA regulations. This pilot program is intended to provide FDA with information to allow the Agency to modernize the FAR submission and review pathway and will permit integration with electronic archive filing systems.
Agency Information Collection Activities: Proposed Collection: Comment Request
Document Number: 2013-10377
Type: Notice
Date: 2013-05-02
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 Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104-13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Reports Clearance Officer at (301) 443-1984. HRSA especially requests comments on: (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. Information Collection Request Title: Health Center Program Application Forms: (OMB No. 0915-0285 Revision). Abstract: Health centers (section 330 grant funded and Federally Qualified Health Center Look-Alikes) deliver comprehensive, high quality, cost-effective primary health care to patients regardless of their ability to pay. Health centers have become an essential primary care provider for America's most vulnerable populations. Health centers advance the preventive and primary medical/health care home model of coordinated, comprehensive, and patient-centered care, coordinating a wide range of medical, dental, behavioral, and social services. More than 1,200 health centers operate nearly 9,000 service delivery sites that provide care in every state, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, and the Pacific Basin. The Health Centers Program is administered by HRSA's Bureau of Primary Health Care (BPHC). HRSA/BPHC uses the following application forms to oversee the Health Center Program. These application forms are used by new and existing Health centers to apply for various grant and non-grant opportunities, renew their grant or non-grant designation, and change their scope of project. Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions, to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information, to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information, and to transmit or otherwise disclose the information. The total annual burden hours estimated for this Information Collection Request are summarized in the table below. The annual estimate of burden is as follows:
Agency Information Collection Activities; Proposed Collection; Comment Request; Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications
Document Number: 2013-10376
Type: Notice
Date: 2013-05-02
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, 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 procedure by which an applicant may obtain an assignment or designation determination for combination products.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2013-10375
Type: Notice
Date: 2013-05-02
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Health Resources and Services Administration (HRSA) will submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB). 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. To request a copy of the clearance requests submitted to OMB for review, email paperwork@hrsa.gov or call the HRSA Reports Clearance Office at (301) 443-1984. Information Collection Request Title: The Health Education Assistance Loan (HEAL) Program Regulations (OMB No. 0915-0108) Extension. Abstract: The Health Education Assistance Loan (HEAL) Program has regulations that contain notification, reporting, and recordkeeping requirements to ensure that the lenders and holders participating in the HEAL program follow sound management procedures in the administration of federally-insured student loans. While the regulatory requirements are approved under the OMB number referenced above, much of the burden associated with the regulations is cleared under separate OMB numbers for the HEAL forms and electronic submissions used to report required information. Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions, to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information, to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information, and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below.
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2013-10360
Type: Notice
Date: 2013-05-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute of Environmental Health Sciences; Notice of Closed Meeting
Document Number: 2013-10342
Type: Notice
Date: 2013-05-02
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2013-10341
Type: Notice
Date: 2013-05-02
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meetings
Document Number: 2013-10340
Type: Notice
Date: 2013-05-02
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Meeting
Document Number: 2013-10339
Type: Notice
Date: 2013-05-02
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2013-10338
Type: Notice
Date: 2013-05-02
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2013-10337
Type: Notice
Date: 2013-05-02
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-10336
Type: Notice
Date: 2013-05-02
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-10335
Type: Notice
Date: 2013-05-02
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-10334
Type: Notice
Date: 2013-05-02
Agency: Department of Health and Human Services, National Institutes of Health
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2013-10324
Type: Notice
Date: 2013-05-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Ashley Brandon Foyle: Debarment Order
Document Number: 2013-10313
Type: Notice
Date: 2013-05-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Ashley Brandon Foyle for 5 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Foyle was convicted of introducing and delivering for introduction into interstate commerce a misbranded drug, which relates to the development or approval, including the process for development or approval, of drug products and to the regulation of drug products under the FD&C Act. In addition, FDA determined that the type of conduct that served as the basis for Mr. Foyle's conviction undermines the process for the regulation of drugs. Mr. Foyle was given notice of the proposed debarment and an opportunity to request a hearing within the prescribed timeframe by regulation but failed to respond. Mr. Foyle's failure to respond constitutes a waiver of his right to a hearing concerning this action.
Announcement of the Award of Three Urgent Single-Source Grants To Support Shelter Care for Unaccompanied Alien Children
Document Number: 2013-10311
Type: Notice
Date: 2013-05-01
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR) announces the award of three urgent single awards to the following organizations.
Notice of Diabetes Mellitus Interagency Coordinating Committee Meeting
Document Number: 2013-10307
Type: Notice
Date: 2013-05-01
Agency: Department of Health and Human Services, National Institutes of Health
The Diabetes Mellitus Interagency Coordinating Committee (DMICC) will hold a meeting on May 23, 2013 from 1:00 to 3:30 p.m. at the Lister Hill Center Auditorium (Building 38A), National Library of Medicine, on the NIH Campus at 8600 Rockville Pike, Bethesda, MD 20894. The meeting is open to the public.
Ryan White HIV/AIDS Program, Part C Early Intervention Services Grant Under the Ryan White HIV/AIDS Program
Document Number: 2013-10304
Type: Notice
Date: 2013-05-01
Agency: Department of Health and Human Services, Health Resources and Services Administration
To prevent a lapse in comprehensive primary care services for persons living with HIV/AIDS, HRSA will provide a one-time noncompetitive Ryan White HIV/AIDS Program Part C funds award to the Bartz-Altadonna Community Health Center (BACHC), Lancaster, California.
Health Center Program
Document Number: 2013-10294
Type: Notice
Date: 2013-05-01
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration (HRSA) will be issuing a non-competitive award of $250,000 under the Health Center Program (section 330 of the Public Health Service Act.) that will be awarded to West End Medical Center, Inc. (WEMC), Atlanta, Georgia, during the budget period June 1, 2012, through May 31, 2013. This award will support the delivery of primary care services in Gwinnett County, Georgia, to prevent a disruption in services.
Submission for OMB Review; Comment Request
Document Number: 2013-10252
Type: Notice
Date: 2013-05-01
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Medical Devices; Inspection by Accredited Persons Program
Document Number: 2013-10248
Type: Notice
Date: 2013-05-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Medical Devices; Inspection by Accredited Persons Program'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance: Emergency Use Authorization of Medical Products
Document Number: 2013-10247
Type: Notice
Date: 2013-05-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Emergency Use Authorization of Medical Products'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Issuance of Final Guidance Publication
Document Number: 2013-10244
Type: Notice
Date: 2013-05-01
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), announces the availability of the following publication: ``NIOSH Current Intelligence Bulletin 65: Occupational Exposure to Carbon Nanotubes and Nanofibers'' [2013-145].
Establishment of the Discretionary Advisory Committee on Heritable Disorders in Newborns and Children and Notice of Meeting
Document Number: 2013-10241
Type: Notice
Date: 2013-05-01
Agency: Department of Health and Human Services
The U.S. Department of Health and Human Services announces the establishment of the Discretionary Advisory Committee on Heritable Disorders in Newborns and Children. This notice also announces the Committee's first meeting.
Submission for OMB Review; Comment Request
Document Number: 2013-10235
Type: Notice
Date: 2013-05-01
Agency: Department of Health and Human Services, Administration for Children and Families
Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
Document Number: 2013-10233
Type: Notice
Date: 2013-05-01
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
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 certified Laboratories and Instrumented Initial Testing Facilities (IITF) is published in the Federal Register during the first week of each month. If any Laboratory/IITF's certification is suspended or revoked, the Laboratory/IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any Laboratory/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 http:// www.workplace.samhsa.gov and http://www.drugfreeworkplace.gov.
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2013-10203
Type: Notice
Date: 2013-05-01
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2013-10202
Type: Notice
Date: 2013-05-01
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Meeting
Document Number: 2013-10201
Type: Notice
Date: 2013-05-01
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2013-10200
Type: Notice
Date: 2013-05-01
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2013-10199
Type: Notice
Date: 2013-05-01
Agency: Department of Health and Human Services, National Institutes of Health