Department of Health and Human Services December 26, 2013 – Federal Register Recent Federal Regulation Documents

Draft Generic Drug User Fee Act Information Technology Plan; Availability for Comment
Document Number: 2013-31008
Type: Notice
Date: 2013-12-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability for public comment of the draft information technology (IT) plan entitled ``GDUFA Information Technology Plan.'' This plan is intended to provide FDA's approach for enhancing business processes, data quality and consistency, supporting technologies, and IT operations as described in the Generic Drug User Fee Act (GDUFA) Performance Goals and Procedures for Fiscal Years 2013 through 2017. FDA is publishing a draft version of the IT plan for comment to allow industry and other interested stakeholders to provide feedback as FDA moves towards a fully automated standards-based environment that enhances the regulatory review process for human pharmaceuticals.
National Institute for Occupational Safety and Health Personal; Notice of public meeting in Endicott, New York
Document Number: 2013-30905
Type: Notice
Date: 2013-12-26
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 a public meeting to present results from a study of former workers of the International Business Machine (IBM) facility in Endicott, New York. This meeting is being held to present study results to stakeholders and members of the public and to offer the opportunity for comments. Meeting Time and Date: January 23, 2014, 6:30 p.m.-8:30 p.m. EST, or after the last public commenter has spoken, whichever occurs first.
Notice of Meeting
Document Number: 2013-30901
Type: Notice
Date: 2013-12-26
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
In accordance with section 10 (a)(2) of the Federal Advisory Committee Act (5 U.S.C. App. 2), announcement is made of an Agency for Healthcare Research and Quality (AHRQ) Special Emphasis Panel (SEP) meeting on ``AHRQ RFA-HS14-003, Disseminating Patient Centered Outcomes Research to Improve Healthcare Delivery Systems (R18)''. Each SEP meeting will commence in open session before closing to the public for the duration of the meeting.
Notice of Request for Comments on Chapters 6 and 8 of the NIOSH document titled: “Criteria for a Recommended Standard: Occupational Exposure to Diacetyl and 2,3-pentanedione”
Document Number: 2013-30900
Type: Notice
Date: 2013-12-26
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) is inviting comments on Chapter 6 and a new section of Chapter 8 of the draft document, ``Criteria for a Recommended Standard: Occupational Exposure to Diacetyl and 2,3-pentanedione.'' To view the notice and related materials, visit http://www.regulations.gov and enter CDC-2013- 0021 in the search field and click ``Search.'' Public Comment Period: Comments must be received by February 10, 2014. Status: Comments are being sought from individuals including scientists and representatives from various government agencies, industry, labor, and other stakeholders, and also the public.
Notice of Meeting
Document Number: 2013-30899
Type: Notice
Date: 2013-12-26
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
In accordance with section 10 (a)(2) of the Federal Advisory Committee Act (5 U.S.C. App. 2), announcement is made of an Agency for Healthcare Research and Quality (AHRQ) Special Emphasis Panel (SEP) meeting on ``AHRQ RFA-HS14-004, PCOR AHRQ Training Program on Patient- Centered Outcomes Methods & Standard Research (R25)''. Each SEP meeting will commence in open session before closing to the public for the duration of the meeting.
Notice of Meetings
Document Number: 2013-30888
Type: Notice
Date: 2013-12-26
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The subcommittees listed below are part of AHRQ's Health Services Research Initial Review Group Committee. Grant applications are to be reviewed and discussed at these meetings. Each subcommittee meeting will commence in open session before closing to the public for the duration of the meeting. These meetings will be closed to the public in accordance with 5 U.S.C. App. 2 section 10(d), 5 U.S.C. section 552b(c)(4), and 5 U.S.C. section 552b(c)(6).
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2013-30840
Type: Notice
Date: 2013-12-26
Agency: Department of Health and Human Services, Office of the Secretary
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 extending the use of the approved information collection assigned OMB control number 0955-0009, which expires on February 28, 2014. Prior to submitting that ICR to OMB, OS 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
Document Number: 2013-30839
Type: Notice
Date: 2013-12-26
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Draft Prescription Drug User Fee Act V Information Technology Plan; Availability for Comment
Document Number: 2013-30818
Type: Notice
Date: 2013-12-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability for public comment of the draft information technology (IT) plan entitled ``PDUFA V Information Technology Plan.'' This plan is intended to provide FDA's approach for enhancing business processes, data quality and consistency, supporting technologies, and IT operations as described in the Prescription Drug User Fee Act (PDUFA) Reauthorization Performance Goals and Procedures for Fiscal Years 2013 through 2017. FDA is publishing a draft version of the IT plan for comment to allow industry and other interested stakeholders to provide feedback as FDA moves towards a fully automated standards-based environment that enhances the regulatory review process for human pharmaceuticals.
Submission for OMB Review; 30-Day Comment Request: Early Career Reviewer Program Online Application System-Center for Scientific Review (CSR)
Document Number: 2013-30817
Type: Notice
Date: 2013-12-26
Agency: Department of Health and Human Services, National Institutes of Health
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Center for Scientific Review, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on March 13, 2013, page 15959 and allowed 60days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The 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 1, 1995, unless it displays a currently valid OMB control number Proposed Collection: Early Career Reviewer Program Online Application SystemExisting collection in use without an OMB number Center for Scientific Review (CSR), National Institutes of Health (NIH). Need and Use of Information Collection: The Center for Scientific Review (CSR) is the portal for NIH grant applications and their review for scientific merit. Our mission is to see that NIH grant applications receive fair, independent, expert, and timely reviewsfree from inappropriate influencesso NIH can fund the most promising research. To accomplish this goal, Scientific Review Officers (SRO) form study sections consisting of scientists who have the technical and scientific expertise to evaluate the merit of grant applications. The CSR Early Career Reviewer (ECR) program was developed to identify and train qualified scientists who are early in their scientific careers and who have not had prior CSR review experience. Currently, the application process involves repeated email interactions with potential applicants and manual management of information. To make the application process more efficient for applicants and for CSR staff, we have collaborated with the Information Management Branch at CSR to develop online application software which includes the collection of applicants' names, contact information, and professional CVs. This PRA clearance request is to deploy the online application software for ECR program applicantsthe Early Career Reviewer Application and Vetting System (EAVS). OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 650.
Proposed Information Collection Activity; Comment Request
Document Number: 2013-30809
Type: Notice
Date: 2013-12-26
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities; Proposed Collection; Comment Request; Information From United States Firms and Processors That Export to the European Community
Document Number: 2013-30804
Type: Notice
Date: 2013-12-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) 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 reporting requirements in implementing the lists of United States (U.S.) firms/processors exporting shell eggs, dairy products, game meat, game meat products, animal casings, gelatin, and collagen to the European Community (the EC).
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-30801
Type: Notice
Date: 2013-12-26
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Draft Guidance for Industry on Naming of Drug Products Containing Salt Drug Substances; Availability
Document Number: 2013-30800
Type: Notice
Date: 2013-12-26
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 ``Naming of Drug Products Containing Salt Drug Substances.'' The United States Pharmacopeial (U.S.P.) Convention has adopted a monograph naming policy that changed the nomenclature for compendial drug products that contain a salt. Under the new policy, drug names and strengths for new compendial drug products will be based on the active moiety. The name and strength of the active ingredient (e.g., salt) will appear elsewhere on the drug product label and labeling. The policy became official on May 1, 2013. This draft guidance describes the U.S.P. policy, discusses the Center for Drug Evaluation and Research's (CDER's) application of the policy, and recommends how CDER and industry can implement the policy.
Allergenic Products Advisory Committee; Notice of Meeting
Document Number: 2013-30799
Type: Notice
Date: 2013-12-26
Agency: Food and Drug Administration, Department of Health and Human Services
Center For Scientific Review; Notice of Closed Meetings
Document Number: 2013-30747
Type: Notice
Date: 2013-12-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases Notice of Closed Meeting
Document Number: 2013-30746
Type: Notice
Date: 2013-12-26
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2013-30745
Type: Notice
Date: 2013-12-26
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-30706
Type: Notice
Date: 2013-12-26
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-30671
Type: Notice
Date: 2013-12-26
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services