Department of Health and Human Services October 5, 2011 – Federal Register Recent Federal Regulation Documents
Results 1 - 26 of 26
Meeting of the Chronic Fatigue Syndrome Advisory Committee
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Chronic Fatigue Syndrome Advisory Committee (CFSAC) will hold a meeting. The meeting will be open to the public.
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. 207 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.
Proposed Collection; Comment Request; STAR METRICS (Science and Technology for America's Reinvestment: Measuring the EffecTs of Research on Innovation, Competitiveness and Science)
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Office of the Director of the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: STAR METRICS (Science and Technology for America's Reinvestment: Measuring the EffecTs of Research on Innovation, Competitiveness and Science). Type of Information Collection Request: Reinstatement of OMB number 0925-0616, expiration date 01/31/2011. Need and Use of Information Collection: The aim of STAR METRICS is twofold. The goal of STAR METRICS is to continue to provide mechanisms that will allow participating universities and Federal agencies with a reliable and consistent means to account for the number of scientists and staff that are on research institution payrolls, supported by Federal funds. In subsequent generations of the program, it is hoped that STAR METRICS will allow for measurement of science impact on economic outcomes (such as job creation), on knowledge generation (such as citations and patents) as well as on social and health outcomes. Frequency of Response: Quarterly. Affected Public: Universities and other research institutions. Type of Respondents: University administrators. The annual reporting burden is as follows: Estimated Number of Respondents: 100. Estimated Number of Responses per Respondent: 4. Average Burden Hours per Response: 2.5. Estimated Total Annual Burden Hours Requested: 1,315. The annualized cost to respondents is estimated to be $65,750. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.
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. 207 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.
Availability of Draft NTP Monograph on the Health Effects of Low-Level Lead; Request for Comments; Announcement of a Panel Meeting to Peer Review Draft Monograph
The NTP announces the availability of the Draft NTP Monograph on the Health Effects of Low-level Lead (available at https:// ntp.niehs.nih.gov/go/36639) that will be peer-reviewed by an NTP Peer Review Panel at a meeting on November 17-18, 2011. The meeting is open to the public with time scheduled for oral public comment. The NTP also invites written comments on the draft monograph (see Request for Comments below).
Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Form 3728, Animal Generic Drug User Fee Act Cover Sheet
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 a 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 burden of the Animal Generic Drug User Fee Cover Sheet Form FDA 3728 that further implements certain provisions of the Animal Generic Drug User Fee Act of 2008 (AGDUFA).
Agency 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 Technical Assistance to ARRA Complex Patient Grantees Project.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on August 3rd, 2011, and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requirements for Submission of Bioequivalence Data
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; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring
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.
Deborah Martinez Seldon: Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Deborah Martinez Seldon 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 Ms. Seldon was convicted of multiple felonies under Federal law for conduct relating to the regulation of a drug product under the FD&C Act. Ms. Seldon was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Ms. Seldon failed to respond. Ms. Seldon's failure to respond constitutes a waiver of her right to a hearing concerning this action.
Preemption Review
The Food and Drug Administration (FDA) is announcing that it has determined, after conducting a review of its existing regulations issued within the past 10 years that contain statements in regulatory preambles or codified provisions intended by the Agency to preempt State law, that three FDA regulatory preambles contain or refer to statements about preemption that are not legally justified. FDA conducted this review in response to the President's May 20, 2009, ``Memorandum for the Heads of Executive Departments and Agencies,'' which outlined the Administration's policy on preemption, in keeping with the principles in Executive Order 13132 on Federalism. The President's memorandum included a directive that such a review be conducted. FDA is also taking this opportunity to clarify certain preamble statements related to preemption resulting from express preemption provisions in the Federal Food, Drug, and Cosmetic Act (FD&C Act) concerning nonprescription drugs and food labeling.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
