Department of Health and Human Services March 2011 – Federal Register Recent Federal Regulation Documents

National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2011-7644
Type: Notice
Date: 2011-03-31
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2011-7643
Type: Notice
Date: 2011-03-31
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2011-7641
Type: Notice
Date: 2011-03-31
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: 2011-7639
Type: Notice
Date: 2011-03-31
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2011-7637
Type: Notice
Date: 2011-03-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2011-7635
Type: Notice
Date: 2011-03-31
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2011-7634
Type: Notice
Date: 2011-03-31
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2011-7625
Type: Notice
Date: 2011-03-31
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2011-7617
Type: Notice
Date: 2011-03-31
Agency: Department of Health and Human Services, National Institutes of Health
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2011-7580
Type: Notice
Date: 2011-03-31
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2011-7578
Type: Notice
Date: 2011-03-31
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2011-7577
Type: Notice
Date: 2011-03-31
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications; Chorionic Gonadotropin; Cuprimyxin; Diethylcarbamazine; Levamisole; Nitrofurazone; Phenylbutazone; Pyrantel; Tylosin; Tylosin and Sulfamethazine
Document Number: 2011-7560
Type: Rule
Date: 2011-03-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of 13 new animal drug applications (NADAs). In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of these NADAs.
Withdrawal of Approval of New Animal Drug Applications; Chorionic Gonadotropin; Cuprimyxin; Diethylcarbamazine; Levamisole; Nitrofurazone; Phenylbutazone; Pyrantel; Tylosin; Tylosin and Sulfamethazine
Document Number: 2011-7558
Type: Notice
Date: 2011-03-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is withdrawing approval of 13 new animal drug applications (NADAs). In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the regulations to remove portions reflecting approval of these NADAs.
Agency Information Collection Activities; Proposed Collection; Comment Request
Document Number: 2011-7443
Type: Notice
Date: 2011-03-31
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
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: ``Understanding Development Methods from Other Industries to Improve the Design of Consumer Health IT.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on January 27th, 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; Proposed Collection; Comment Request
Document Number: 2011-7430
Type: Notice
Date: 2011-03-31
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
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: ``Voluntary Customer Survey Generic Clearance for the Agency for Healthcare Research and Quality.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on January 25th, 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.
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-October Through December 2010
Document Number: 2011-7373
Type: Notice
Date: 2011-03-31
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from October through December 2010, relating to the Medicare and Medicaid programs.
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2011-7500
Type: Notice
Date: 2011-03-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2011-7499
Type: Notice
Date: 2011-03-30
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2011-7498
Type: Notice
Date: 2011-03-30
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2011-7496
Type: Notice
Date: 2011-03-30
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary and Alternative Medicine Announcement of Stakeholder Roundtable
Document Number: 2011-7495
Type: Notice
Date: 2011-03-30
Agency: Department of Health and Human Services, National Institutes of Health
The National Center for Complementary and Alternative Medicine (NCCAM) invites the public to a Stakeholder Roundtable. Attendees will meet the NCCAM Director and discuss the Center's new strategic plan, activities, and priorities. The Roundtable will take place: 8:30 a.m.- 11 a.m., Tuesday, April 26, 2011, Building 31, 6C, Room 10, National Institutes of Health, 9000 Rockville Pike, Bethesda, MD. To allow for meaningful interaction, space is limited. To attend, please RSVP by Friday, April 1, 2011, by contacting Carina May at 301- 915-9763 or cmay@thehillgroup.com. Representatives from professional medical societies as well as consumer organizations are particularly encouraged to attend. Background: The National Center for Complementary and Alternative Medicine (NCCAM) was established in 1999. The mission of NCCAM is to define, through rigorous scientific investigation, the usefulness and safety of complementary and alternative medicine interventions and their roles in improving health and health care To date, NCCAM's efforts to meet its mission have been guided by NCCAM's strategic plans located on the NCCAM Web site at http:// nccam.nih.gov/about/plans/. Request for Participation: Representatives of stakeholder organizations are invited to provide input into the NCCAM's priorities and activities at a Stakeholder Roundtable. This event will give NCCAM stakeholders an opportunity to voice their opinions regarding future directions for research, training, outreach, and integration in complementary and alternative medicine (CAM). The Dialogue will be held: 8:30 a.m.-11 a.m., Tuesday, April 26, 2011, Building 31, 6C, Room 10, National Institutes of Health, 9000 Rockville Pike, Bethesda, MD. NCCAM's director will provide an overview of NCCAM's history and current activities, followed by a discussion with attendees. Representatives from the complementary and alternative medicine community are particularly encouraged to attend. To allow for meaningful interaction, space is limited. To attend, please RSVP by Friday, April 1, 2011, by contacting Carina May at 301-915-9763 or cmay@thehillgroup.com.
National Library of Medicine; Notice of Closed Meeting
Document Number: 2011-7494
Type: Notice
Date: 2011-03-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Meeting
Document Number: 2011-7491
Type: Notice
Date: 2011-03-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2011-7489
Type: Notice
Date: 2011-03-30
Agency: Department of Health and Human Services, National Institutes of Health
Public Meeting of the Consumer Operated and Oriented Plan (CO-OP) Advisory Board, April 15, 2011
Document Number: 2011-7484
Type: Notice
Date: 2011-03-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the fourth meeting of an advisory committee to the Center for Consumer Information and Insurance Oversight (CCIIO) in accordance with the Federal Advisory Committee Act. The meeting is open to the public and will be conducted by telephone. The purpose of the meeting is to assist and advise the Secretary of the Department of Health and Human Services' through CCIIO strategy to foster the creation of qualified nonprofit consumer- operated health insurance issuers.
National Forum for State and Territorial Chief Executives (National Forum) Program Cooperative Agreement
Document Number: 2011-7444
Type: Notice
Date: 2011-03-30
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA will be providing a one-year extension with funds in the amount authorized in fiscal year (FY) 2010 to support activities that focus on cross-cutting publicly-funded health program integration and health access issues identified by the State and Territory governors and their senior health policy advisors, including addressing the needs of uninsured, underinsured and special needs populations, oral health, border health and health information technology as well as HRSA's overall strategic goals.
Medical Device Epidemiology Network 2011: Second Annual Public Workshop
Document Number: 2011-7434
Type: Notice
Date: 2011-03-30
Agency: Food and Drug Administration, Department of Health and Human Services
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Additional Listing Information for Medical Device Registration and Listing
Document Number: 2011-7389
Type: Notice
Date: 2011-03-30
Agency: Food and Drug Administration, Department of Health and Human Services
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; Announcement of Office of Management and Budget Approval; Medical Devices: Recommended Glossary and Educational Outreach To Support Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use
Document Number: 2011-7387
Type: Notice
Date: 2011-03-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Medical Devices: Recommended Glossary and Educational Outreach to Support Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Proposed Information Collection Activity: Comment Request
Document Number: 2011-7340
Type: Notice
Date: 2011-03-30
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Document Number: 2011-7338
Type: Notice
Date: 2011-03-30
Agency: Department of Health and Human Services, Administration for Children and Families
Submission for OMB Review; Comment Request
Document Number: 2011-7337
Type: Notice
Date: 2011-03-30
Agency: Department of Health and Human Services, Administration for Children and Families
Federal Health IT Strategic Plan: 2011-2015 Open Comment Period
Document Number: 2011-7318
Type: Notice
Date: 2011-03-29
Agency: Department of Health and Human Services
Section 3001(c)(3) of the Public Health Service Act, as added by the Health Information Technology for Economic and Clinical Health (HITECH) Act, requires the National Coordinator for Health Information Technology (ONC) to update the Federal Health IT Strategic Plan (developed June 3, 2008) in consultation with other appropriate Federal agencies and in collaboration with private and public entities. Work on the five-year Plan began more than a year ago and has included collaboration across federal agencies, as well with the private sector via the HIT Policy Committee. This notice serves to announce that the public comment period for the Federal Health IT Strategic Plan is open through Friday, April 22 at 11:59 p.m. (Eastern). ONC welcomes and encourages all comments from the public regarding the Plan. In order for your comments to be read and considered, you must submit your comment via the Federal Health IT Buzz Blog: http:// www.healthit.gov/buzz-blog/.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2011-7317
Type: Notice
Date: 2011-03-29
Agency: Department of Health and Human Services, Health Resources and Services Administration
Laboratory Animal Welfare: Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals
Document Number: 2011-7316
Type: Notice
Date: 2011-03-29
Agency: Department of Health and Human Services, National Institutes of Health
The National Institutes of Health (NIH) is extending the period for public comments on (1) NIH's adoption of the eighth edition of the Guide for the Care and Use of Laboratory Animals (Guide) as a basis for evaluation of institutional programs receiving or proposing to receive Public Health Service (PHS) support for activities involving animals; and (2) if NIH decides to adopt the eighth edition of the Guide, NIH's proposed implementation plan, which would require that institutions complete at least one semiannual program and facility evaluation using the eighth edition of the Guide as the basis for evaluation by March 31, 2012. NIH will consider comments on (1) the adoption of the Guide and (2) the implementation plan. The notice on the proposed adoption and implementation plan for the eighth edition of the Guide was published in the Federal Register on February 24, 2011 (76 FR 10379). The comment period is extended by 30 days and thus will end on April 24, 2011.
New Animal Drugs; Amikacin Sulfate, Ampicillin Trihydrate, Ceftiofur Hydrochloride, Cephapirin Benzathine, Chlortetracycline, Fenbendazole, Formalin, Furosemide, Glucose/Glycine/Electrolyte, Pyrantel Pamoate, Sulfadimethoxine, Sulfamethazine, and Tetracycline
Document Number: 2011-7313
Type: Rule
Date: 2011-03-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect revised human food safety warnings or updated pathogen nomenclature on dosage form new animal drug product labeling that have not been codified. The regulations are also being amended to correct the wording of certain other conditions of use, to correct minor errors, and to revise some sections to reflect a current format. These actions are being taken to comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and to improve the accuracy and readability of the regulations.
Agency Information Collection Activities; Proposed Collection; Comment Request; Extension of Certification on Maintenance of Effort for the Title III and Minor Revisions to the Certification of Long-Term Care Ombudsman Program Expenditures
Document Number: 2011-7301
Type: Notice
Date: 2011-03-29
Agency: Aging Administration, Department of Health and Human Services
The Administration on Aging (AoA) 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 information collection requirements relating to the Certification on Maintenance of Effort under Title III and Certification of Long-Term Care Ombudsman Program Expenditures for OAA Title III and Title VII Grantees.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2011-7300
Type: Notice
Date: 2011-03-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Request for Information on Conditions Relating to Cancer To Consider for the World Trade Center Health Program
Document Number: 2011-7299
Type: Notice
Date: 2011-03-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
On March 8, 2011, the Director of the National Institute of Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) published a notice in the Federal Register (76 FR 12740) requesting information from the public on three questions regarding conditions relating to cancer for consideration under the World Trade Center Health Program. Written comment was to be received by March 31, 2011. NIOSH has received comment about extending the request for information to include persons living and working in the affected area. In consideration of that comment, the Director of NIOSH is modifying one of the questions posed in the Federal Register and extending the public comment period to April 29, 2011.
Agency Information Collection Request; 60-Day Public Comment Request
Document Number: 2011-7292
Type: Notice
Date: 2011-03-29
Agency: Department of Health and Human Services
Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: 2011-7259
Type: Notice
Date: 2011-03-29
Agency: Food and Drug Administration, Department of Health and Human Services
Proposed Information Collection Activity; Comment Request
Document Number: 2011-7157
Type: Notice
Date: 2011-03-29
Agency: Department of Health and Human Services, Administration for Children and Families
Health Center Program
Document Number: 2011-7248
Type: Notice
Date: 2011-03-28
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration (HRSA) will transfer the remaining American Recovery and Reinvestment Act (ARRA) Capital Improvement Project (CIP) from Saint Vincent's Catholic Medical Centers (SVCMC) of New York, current grantee of record, to Sunset Park Health Council (SPHC), Inc. in order to continue primary health care services to low-income, underserved homeless patients in New York City.
New Animal Drugs; Oxytetracycline
Document Number: 2011-7216
Type: Rule
Date: 2011-03-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Pennfield Oil Co. The supplemental ANADA provides for use of oxytetracycline hydrochloride soluble powder for control of American and European foulbrood in honey bees and for skeletal marking of finfish fry and fingerlings.
Pregnancy and Prescription Medication Use Symposium
Document Number: 2011-7215
Type: Notice
Date: 2011-03-28
Agency: Food and Drug Administration, Department of Health and Human Services
New Animal Drugs; Arsanilate Sodium; Sulfaethoxypyridazine
Document Number: 2011-7214
Type: Rule
Date: 2011-03-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to remove sections pertaining to use of arsanilate sodium and sulfaethoxypyridazine in medicated feed because there are no currently approved new animal drug applications (NADAs) for such uses. Conforming amendments are also being made. This action is being taken to improve the accuracy of the regulations.
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
Document Number: 2011-7212
Type: Notice
Date: 2011-03-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the Agency's Division of Dockets Management.
Clarifying Edits to Existing Special Controls Guidance Documents; Availability
Document Number: 2011-7211
Type: Notice
Date: 2011-03-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of updated special controls guidance documents for class II devices, which contain edits that reflect the Agency's effort to clarify questions and confusion regarding its position on the binding nature of special controls guidance documents. The revised language does not change the Agency's position or view, but rather is intended to clarify its position and remedy any possible confusion or misunderstanding.
National Center for Complementary & Alternative Medicine; Notice of Closed Meeting
Document Number: 2011-7199
Type: Notice
Date: 2011-03-28
Agency: Department of Health and Human Services, National Institutes of Health