Department of Health and Human Services August 17, 2011 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2011-20999
Type: Notice
Date: 2011-08-17
Agency: Department of Health and Human Services, Health Resources and Services Administration
Proposed Collection; Comment Request; National Institutes of Health Construction Grants
Document Number: 2011-20961
Type: Notice
Date: 2011-08-17
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for public comment on proposed data collection projects, 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: National Institutes of Health Construction Grants 42 CFR Part 52b (Final Rule). Type of Information Collection Request: Extension of OMB Control No. 0925-0424, expiration date 10/31/2011. Need and Use of the Information Collection: This request is for OMB review and approval of a renewal for the information collection and recordkeeping requirements contained in the regulation codified at 42 CFR part 52b. The purpose of the regulation is to govern the awarding and administration of grants awarded by NIH and its components for construction of new buildings and the alteration, renovation, remodeling, improvement, expansion, and repair of existing buildings, including the provision of equipment necessary to make the buildings (or applicable part of the buildings) suitable for the purpose for which it was constructed. In terms of reporting requirements: Section 52b.9(b) of the regulation requires the transferor of a facility which is sold or transferred, or owner of a facility, the use of which has changed, to provide written notice of the sale, transfer or change within 30 days. Section 52b.10(f) requires a grantee to submit an approved copy of the construction schedule prior to the start of construction. Section 52b.10(g) requires a grantee to provide daily construction logs and monthly status reports upon request at the job site. Section 52b.11(b) requires applicants for a project involving the acquisition of existing facilities to provide the estimated cost of the project, cost of the acquisition of existing facilities, and cost of remodeling, renovating, or altering facilities to serve the purposes for which they are acquired. In terms of recordkeeping requirements: Section 52b.10(g) requires grantees to maintain daily construction logs and monthly status reports at the job site. Frequency of Response: On occasion. Affected Public: Non-profit organizations and Federal agencies. Type of respondents: Grantees. The estimated respondent burden is as follows:
Availability of Draft NTP Monograph on Potential Developmental Effects of Cancer Chemotherapy During Pregnancy; Request for Comments; Announcement of a Panel Meeting To Peer Review Draft Monograph
Document Number: 2011-20958
Type: Notice
Date: 2011-08-17
Agency: Department of Health and Human Services
The NTP announces the availability of the Draft NTP Monograph on Potential Developmental Effects of Cancer Chemotherapy During Pregnancy (available at https://ntp.niehs.nih.gov/go/36639) that will be peer reviewed by an NTP Peer Review Panel at a meeting on October 19- 20, 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).
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Meeting
Document Number: 2011-20946
Type: Notice
Date: 2011-08-17
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Meeting
Document Number: 2011-20944
Type: Notice
Date: 2011-08-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Meeting
Document Number: 2011-20941
Type: Notice
Date: 2011-08-17
Agency: Department of Health and Human Services, National Institutes of Health
Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: 2011-20925
Type: Notice
Date: 2011-08-17
Agency: Department of Health and Human Services
HHS gives notice of a decision to designate a class of employees from Sandia National Laboratories in Albuquerque, New Mexico, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On July 29, 2011, the Secretary of HHS designated the following class of employees as an addition to the SEC:
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2011-20920
Type: Notice
Date: 2011-08-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2011-20919
Type: Notice
Date: 2011-08-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells; Withdrawal of Draft Guidance
Document Number: 2011-20862
Type: Notice
Date: 2011-08-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the withdrawal of a draft guidance entitled ``Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells (PBSCs)'' dated July 2007.
Hemoglobin Standards and Maintaining Adequate Iron Stores in Blood Donors; Public Workshop
Document Number: 2011-20861
Type: Notice
Date: 2011-08-17
Agency: Food and Drug Administration, Department of Health and Human Services
Statement of Organizations, Functions, and Delegations of Authority
Document Number: 2011-20859
Type: Notice
Date: 2011-08-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that it has reorganized the Center for Drug Evaluation and Research (CDER) by establishing four new Divisions under the Office of Generic Drugs. This reorganization includes the organization and their substructure components as listed in this document. This document is announcing the availability of the Staff Manual Guide that explains the details of this reorganization.
Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice; Public Workshop
Document Number: 2011-20858
Type: Notice
Date: 2011-08-17
Agency: Food and Drug Administration, Department of Health and Human Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2011-20857
Type: Notice
Date: 2011-08-17
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2011-20856
Type: Notice
Date: 2011-08-17
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2011-20855
Type: Notice
Date: 2011-08-17
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Determination That Halflytely and Bisacodyl Tablets Bowel Prep Kit (Containing Two Bisacodyl Delayed Release Tablets, 5 Milligrams) Was Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2011-20853
Type: Notice
Date: 2011-08-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined that Halflytely and Bisacodyl Tablets Bowel Prep Kit (polyethylene glycol (PEG) 3350, sodium chloride, sodium bicarbonate, and potassium chloride for oral solution and two bisacodyl delayed release tablets, 5 milligrams (mg) (10-mg bisacodyl)) was withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve abbreviated new drug applications (ANDAs) for bowel prep kits containing PEG-3350, sodium chloride, sodium bicarbonate, and potassium chloride for oral solution and two bisacodyl delayed release tablets, 5 mg.
Guidance for Industry on Residual Drug in Transdermal and Related Drug Delivery Systems; Availability
Document Number: 2011-20852
Type: Notice
Date: 2011-08-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Residual Drug in Transdermal and Related Drug Delivery Systems.'' This guidance provides recommendations to developers and manufacturers of transdermal drug delivery systems (TDDS), transmucosal drug delivery systems (TMDS), and topical patch products regarding use of an appropriate scientific approach during product design and developmentas well as during manufacturing and product life-cycle managementto ensure that the amount of residual drug substance at the end of the labeled use period is minimized. The guidance is applicable to investigational new drug applications, new drug applications, abbreviated new drug applications, and supplemental new drug applications for TDDS, TMDS, and topical patch products.
Patient Protection and Affordable Care Act; Exchange Functions in the Individual Market: Eligibility Determinations; Exchange Standards for Employers
Document Number: 2011-20776
Type: Proposed Rule
Date: 2011-08-17
Agency: Department of Health and Human Services
This proposed rule would implement certain functions of the new Affordable Insurance Exchanges (``Exchanges''), consistent with title I of the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, referred to collectively as the Affordable Care Act. The Exchanges will provide competitive marketplaces for individuals and small employers to directly compare available private health insurance options on the basis of price, quality, and other factors. The Exchanges, which will become operational by January 1, 2014, will help enhance competition in the health insurance market, improve choice of affordable health insurance, and give small businesses the same purchasing clout as large businesses. The specific Exchange functions proposed in this rule include: Eligibility determinations for Exchange participation and insurance affordability programs and standards for employer participation in SHOP.
Medicaid Program; Eligibility Changes Under the Affordable Care Act of 2010
Document Number: 2011-20756
Type: Proposed Rule
Date: 2011-08-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would implement provisions of the Patient Protection and Affordable Care Act of 2010 and the Health Care and Education Reconciliation Act of 2010 (collectively referred to as the Affordable Care Act). The Affordable Care Act expands access to health insurance through improvements in Medicaid, the establishment of Affordable Insurance Exchanges (``Exchanges''), and coordination between Medicaid, the Children's Health Insurance Program (CHIP), and Exchanges. This proposed rule would implement sections of the Affordable Care Act related to Medicaid and CHIP eligibility, enrollment simplification, and coordination. In addition, this proposed rule also sets out the increased Federal Medical Assistance Percentage (FMAP) rates and the related conditions and requirements that will be available for State medical assistance expenditures relating to ``newly eligible'' individuals and certain medical assistance expenditures in ``expansion States'' beginning January 1, 2014, including a proposal of three alternative methodologies to use for purposes of applying the appropriate FMAP for expenditures in accordance with section 2001 of the Affordable Care Act.
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