Department of Health and Human Services May 2, 2013 – Federal Register Recent Federal Regulation Documents

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
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