Department of Health and Human Services November 17, 2014 – Federal Register Recent Federal Regulation Documents

Advisory Commission on Childhood Vaccines; Notice of Meeting
Document Number: 2014-27188
Type: Notice
Date: 2014-11-17
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2014-27137
Type: Notice
Date: 2014-11-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2014-27135
Type: Notice
Date: 2014-11-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Announcing the Award of a Single-Source Program Expansion Supplement Grant to the Futures Without Violence in San Francisco, CA
Document Number: 2014-27131
Type: Notice
Date: 2014-11-17
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB), Division of Family Violence Prevention and Services (DFVPS) announces the award of $270,000 as a single-source program expansion supplement to Futures Without Violence in San Francisco, CA. The grantee, funded under the Family Violence Protection and Services Act (FVPSA) program, is a technical assistance (TA) provider that serves as the FVPSA-funded National Health Resource Center on Domestic Violence.
Government-Owned Inventions; Availability for Licensing
Document Number: 2014-27083
Type: Notice
Date: 2014-11-17
Agency: Department of Health and Human Services, National Institutes of Health
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.
National Institute of Mental Health: Notice of Closed Meeting
Document Number: 2014-27060
Type: Notice
Date: 2014-11-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Closed Meeting
Document Number: 2014-27059
Type: Notice
Date: 2014-11-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases: Notice of Closed Meetings
Document Number: 2014-27058
Type: Notice
Date: 2014-11-17
Agency: Department of Health and Human Services, National Institutes of Health
Smith Miller and Patch, Inc. et al.; Withdrawal of Approval of 14 New Drug Applications
Document Number: 2014-27039
Type: Notice
Date: 2014-11-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is withdrawing approval of 14 new drug applications (NDAs) from multiple holders of these applications. The basis for the withdrawals is that the holders of the applications have repeatedly failed to file required annual reports for the applications.
Additions and Modifications to the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness; Correction
Document Number: 2014-27038
Type: Proposed Rule
Date: 2014-11-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a document entitled ``Additions and Modifications to the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness'' that appeared in the Federal Register of July 2, 2014. The document proposed amending FDA's regulations to revise the list of drug products that may not be compounded under the exemptions provided by the Federal Food, Drug, and Cosmetic Act because the drug products have been withdrawn or removed from the market after the drug products or components of such drug products were found to be unsafe or not effective. The document also withdrew the previous proposed rule regarding additions to this list (see the Federal Register of January 4, 2000). The document was published with an incorrect RIN number. This document corrects the error.
Rare Pediatric Disease Priority Review Vouchers, Draft Guidance for Industry; Availability
Document Number: 2014-27022
Type: Notice
Date: 2014-11-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Rare Pediatric Disease Priority Review Vouchers.'' Under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), FDA will award priority review vouchers to sponsors of certain rare pediatric disease product applications that meet the criteria specified in that section. These vouchers can be used when submitting future human drug marketing applications that would not otherwise qualify for priority review. These vouchers can be sold or transferred for use to another sponsor any number of times before the voucher is used, as long as the sponsor making the transfer has not yet submitted the application. Because there exists a need for products for rare pediatric diseases, this program is intended to encourage development of new drug and biological products for prevention and treatment of certain rare pediatric diseases.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2014-27018
Type: Notice
Date: 2014-11-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2014-27017
Type: Notice
Date: 2014-11-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Flexibility, Efficiency, and Modernization in Child Support Enforcement Programs
Document Number: 2014-26822
Type: Proposed Rule
Date: 2014-11-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Administration for Children and Families
This NPRM is intended to carry out the President's directives in Executive Order 13563: Improving Regulation and Regulatory Review. The NPRM proposes revisions to make Child Support Enforcement program operations and enforcement procedures more flexible, more effective, and more efficient by recognizing the strength of existing state enforcement programs, advancements in technology that can enable improved collection rates, and the move toward electronic communication and document management. This NPRM proposes to improve and simplify program operations, and remove outmoded limitations to program innovations to better serve families. In addition, changes are proposed to clarify and correct technical provisions in existing regulations.