Department of Health and Human Services October 2007 – Federal Register Recent Federal Regulation Documents

Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: E7-21423
Type: Notice
Date: 2007-10-31
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E7-21416
Type: Notice
Date: 2007-10-31
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: E7-21415
Type: Notice
Date: 2007-10-31
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Office of Biotechnology Activities; Recombinant DNA Research: Action Under the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines)
Document Number: E7-21404
Type: Notice
Date: 2007-10-31
Agency: Department of Health and Human Services, National Institutes of Health
Specific proposals to conduct research involving the deliberate transfer of a drug resistance trait to a microorganism that causes disease in humans have been reviewed by the Recombinant DNA Advisory Committee (RAC) and approved by the NIH Director. Approval of these experiments constitutes a Major Action under section III-A-1 of the NIH Guidelines.
Guidance for Industry on the Role of Human Immunodeficiency Virus Resistance Testing in Antiretroviral Drug Development; Availability
Document Number: E7-21403
Type: Notice
Date: 2007-10-31
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 ``Role of HIV Resistance Testing in Antiretroviral Drug Development.'' This guidance is intended to assist sponsors in the clinical development of drugs for the treatment of human immunodeficiency virus (HIV) infection. Specifically, this guidance addresses the agency's current thinking regarding the role of HIV resistance testing during antiretroviral drug development and postmarketing. This guidance discusses important nonclinical studies that are recommended before the initiation of phase 1 clinical studies in HIV-infected patients. In addition, this guidance addresses the use of resistance testing in clinical phases of drug development and recommends the type of information that should be collected and the types of analyses that should be conducted to characterize an antiretroviral's resistance profile. This guidance finalizes the draft guidance published on November 29, 2004.
Fees for Sanitation Inspections of Cruise Ships [Correction]
Document Number: E7-21398
Type: Notice
Date: 2007-10-31
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Correction: This notice was published in the Federal Register on October 4, 2007, Volume 72, Number 192, page 56768. The contact e- mail address should read as follows: Jfa0@cdc.gov
Government-Owned Inventions; Availability for Licensing
Document Number: E7-21370
Type: Notice
Date: 2007-10-31
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. 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.
Notice to Administratively Impose a Matching Requirement
Document Number: E7-21344
Type: Notice
Date: 2007-10-31
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
The Administration for Children and Families (ACF) hereby gives notice to the public that certain programs within the Agency will be administratively imposing a matching requirement on grants awarded under the following program titles and funding opportunity announcements for Fiscal Year 2008:
Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food and Drug Administration Staff: Public Availability of Advisory Committee Members' Financial Interest Information and Waivers; Availability
Document Number: 07-5408
Type: Notice
Date: 2007-10-31
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 document for the public, FDA advisory committee members, and FDA staff entitled ``Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Public Availability of Advisory Committee Members' Financial Interest Information and Waivers.'' This guidance is intended to help the public, FDA advisory committee members, and FDA staff to understand and implement FDA procedures regarding public availability of information regarding certain financial interests and waivers granted by FDA to permit individuals to participate in an advisory committee meeting. The draft guidance announced in this notice supersedes FDA's ``Draft Guidance on Disclosure of Conflicts of Interest for Special Government Employees Participating in FDA Product Specific Advisory Committees,'' dated January 2002.
Revisit User Fee Program for Medicare Survey and Certification Activities
Document Number: 07-5400
Type: Rule
Date: 2007-10-31
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This interim final rule with comment period implements the continuation of the revisit user fee program for Medicare Survey and Certification activities, in accordance with the statutory authority in the Continuing Appropriations Resolution (``Continuing Resolution'') budget legislation passed by the Congress and signed by the President on September 29, 2007. On September 19, 2007, we published a final rule that established a system of revisit user fees applicable to health care facilities that have been cited for deficiencies during initial certification, recertification or substantiated complaint surveys and require a revisit to confirm that corrections to previously-identified deficiencies have been corrected.
National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 07-5395
Type: Notice
Date: 2007-10-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 07-5394
Type: Notice
Date: 2007-10-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 07-5393
Type: Notice
Date: 2007-10-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute On Drug Abuse; Notice of Closed Meeting
Document Number: 07-5392
Type: Notice
Date: 2007-10-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting
Document Number: 07-5391
Type: Notice
Date: 2007-10-31
Agency: Department of Health and Human Services, National Institutes of Health
Draft Guidance for Industry on Acute Bacterial Sinusitis: Developing Drugs for Treatment; Availability
Document Number: E7-21332
Type: Notice
Date: 2007-10-30
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 ``Acute Bacterial Sinusitis: Developing Drugs for Treatment.'' The purpose of this guidance is to assist clinical trial sponsors and investigators in the development of antimicrobial drug products for the treatment of acute bacterial sinusitis (ABS). The agency's thinking in this area has evolved in recent years, and this draft guidance, when finalized, will inform sponsors of our current thinking in this area. In addition, it will fulfill a statutory requirement to publish such a guidance enacted in the Food and Drug Administration Amendments Act of 2007 (FDAAA).
Reimbursement of Travel and Subsistence Expenses Toward Living Organ Donation Proposed Eligibility Guidelines and Publication of Final Program Eligibility Guidelines
Document Number: E7-21309
Type: Notice
Date: 2007-10-30
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration published a notice in the Federal Register of October 5, 2007 (FR Doc. E7-19747), on pages 57049-57052, regarding response to solicitation of comments and publication of final program eligibility guidelines.
Biomin GmbH; Filing of Food Additive Petition
Document Number: E7-21298
Type: Notice
Date: 2007-10-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that Biomin GmbH, Industriestrasse 21, Herzogenburg, Austria 3130, has filed a petition proposing that the food additive regulations be amended to provide for the safe use of Eubacterium bacterial species in feed for detoxifying trichothecene mycotoxins in the digestive tracts of swine and poultry.
Privacy Act of 1974: New System of Records
Document Number: 07-5379
Type: Notice
Date: 2007-10-30
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the requirements of the Privacy Act, the Health Resources and Services Administration (HRSA) is publishing a notice of a proposal to add a new system of records. The Campus Based Branch (CBB) of the Division of Health Careers Diversity and Development in the Bureau of Health Professions is currently utilizing a document management system (DMS) that dynamically manages its flow of documents produced and received. the DMS is an intra-office system in which documents contained within the system are only shared among CBB staff. The DMS contains names and other personally identifiable information of borrowers.
Office of the National Coordinator for Health Information Technology; American Health Information Community Chronic Care Workgroup Meeting
Document Number: 07-5378
Type: Notice
Date: 2007-10-30
Agency: Department of Health and Human Services
This notice anounces the 20th meeting of the American Health Information Community Chronic Care Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.)
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 07-5376
Type: Notice
Date: 2007-10-30
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Draft Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility; Availability
Document Number: E7-21268
Type: Notice
Date: 2007-10-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility'' dated October 2007. The draft guidance document provides assistance to blood establishments in developing a blood establishment computer system validation program, consistent with recognized principles of software validation, quality assurance, and current good software engineering practices. In the Federal Register of March 9, 2005 (70 FR 11679), FDA withdrew the guidance document entitled ``Draft Guideline for the Validation of Blood Establishment Computer Systems,'' issued on September 28, 1993, and is issuing this guidance to reflect our current considerations on this topic.
Guidance for Industry: Considerations for Plasmid Deoxyribonucleic Acid Vaccines for Infectious Disease Indications; Availability
Document Number: E7-21266
Type: Notice
Date: 2007-10-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications'' dated November 2007. The guidance document is intended to assist manufacturers and sponsors in the development of deoxyribonucleic acid (DNA) vaccines to prevent infectious diseases. The guidance supersedes the guidance document entitled ``Points to Consider on Plasmid DNA Vaccines for Preventive Infectious Disease Indications'' dated December 1996. In addition, the guidance announced in this notice finalizes the draft guidance of the same title dated February 2005.
National Institute for Occupational Safety and Health; Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: E7-21222
Type: Notice
Date: 2007-10-29
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS) gives notice concerning the final effect of the HHS decision to designate a class of employees at the Ames Laboratory, Ames, Iowa, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On September 12, 2007, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
National Institute for Occupational Safety and Health; Decision To Evaluate a Petition To Designate a Class of Employees at Combustion Engineering, Windsor, CT, To Be Included in the Special Exposure Cohort
Document Number: E7-21220
Type: Notice
Date: 2007-10-29
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at Combustion Engineering, Windsor, Connecticut, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Combustion Engineering. Location: Windsor, Connecticut. Job Titles and/or Job Duties: All workers. Period of Employment: January 1, 1965 through December 31, 1972.
National Institute for Occupational Safety and Health; Decision To Evaluate a Petition To Designate a Class of Employees at Area IV of the Santa Susana Field Laboratory, Santa Susana, CA, To Be Included in the Special Exposure Cohort
Document Number: E7-21217
Type: Notice
Date: 2007-10-29
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at Area IV of the Santa Susana Field Laboratory, Santa Susana, California, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Area IV of the Santa Susana Field Laboratory. Location: Santa Susana, California. Job Titles and/or Job Duties: All workers. Period of Employment: January 1, 1955 through December 31, 1965.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: E7-21208
Type: Notice
Date: 2007-10-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E7-21196
Type: Notice
Date: 2007-10-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Decision To Evaluate a Petition To Designate a Class of Employees at Horizons, Inc., Cleveland, OH, To Be Included in the Special Exposure Cohort
Document Number: E7-21191
Type: Notice
Date: 2007-10-29
Agency: National Institute for Occupational Safety and Health, Department of Health and Human Services
The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at Horizons, Inc., Cleveland, Ohio, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Horizons, Inc. Location: Cleveland, Ohio. Job Titles and/or Job Duties: All workers. Period of Employment: January 1, 1944 through December 31, 1956; and January 1, 1957 through July 31, 2006 (residual period).
National Institute for Occupational Safety and Health; Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: E7-21177
Type: Notice
Date: 2007-10-29
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS) gives notice concerning the final effect of the HHS decision to designate a class of employees at the Hanford Engineer Works, Richland, Washington, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On September 12, 2007, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
National Institute for Occupational Safety and Health; Decision To Evaluate a Petition To Designate a Class of Employees at the Westinghouse Atomic Power Development Plant, East Pittsburgh, PA, To Be Included in the Special Exposure Cohort
Document Number: E7-21152
Type: Notice
Date: 2007-10-29
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at the Westinghouse Atomic Power Development Plant, East Pittsburgh, Pennsylvania, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Westinghouse Atomic Power Development Plant. Location: East Pittsburgh, Pennsylvania. Job Titles and/or Job Duties: All testers and laboratory researchers (to include research group leaders who worked in the L Building (and K Building as applicable). Period of Employment: January 1, 1942 through December 31, 1944.
Agency Information Collection Request; 30-Day Public Comment Request
Document Number: E7-21149
Type: Notice
Date: 2007-10-29
Agency: Department of Health and Human Services
Medicare Program; Hospital Conditions of Participation: Requirements for Approval and Re-Approval of Transplant Centers To Perform Organ Transplants
Document Number: E7-21213
Type: Rule
Date: 2007-10-26
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
On March 30, 2007, we published a final rule entitled ``Medicare Program; Hospital Conditions of Participation: Requirements for Approval and Re-Approval of Transplant Centers to Perform Organ Transplants.'' The effective date was June 28, 2007. This correcting amendment corrects a technical error identified in the March 30, 2007 final rule.
Protection of Human Subjects: Categories of Research That May Be Reviewed by the Institutional Review Board Through an Expedited Review Procedure
Document Number: E7-21126
Type: Notice
Date: 2007-10-26
Agency: Department of Health and Human Services
The Office for Human Research Protections (OHRP) is requesting written comments on a proposed amendment to item 5 of the categories of research that may be reviewed by the institutional review board (IRB) through an expedited review procedure, last published in the Federal Register on November 9, 1998 (63 FR 60364). On that date, the Office for Protection from Research Risks (OPRR), now OHRP, and the Food and Drug Administration (FDA) simultaneously published identical lists of categories of research activities involving human subjects which may be reviewed by the IRB through an expedited review procedure. It has come to OHRP's attention that there has been confusion in the research community about expedited review category 5. OHRP is proposing to amend expedited review category 5 to clarify that the category includes research involving materials that were previously collected for either nonresearch or research purposes, provided that any materials collected for research were not collected for the currently proposed research. Expedited review category 5 also includes research involving materials that will be collected solely for nonresearch purposes. In addition, OHRP is requesting comments on the entire expedited review list that was last published in the Federal Register on November 9, 1998 (63 FR 60364) to determine if other changes are needed. As part of its charge to provide expert advice and recommendations to the Secretary of Health and Human Services (the Secretary) and the Assistant Secretary for Health on issues and topics pertaining to or associated with the protection of human research subjects, the Secretary's Advisory Committee on Human Research Protections (SACHRP), through its Subcommittee on Subpart A, considered whether the current expedited review categories should be modified. On March 14, 2007, SACHRP submitted recommendations regarding expedited review to the Secretary, and on June 18, 2007, the Secretary sent a letter to the SACHRP chairperson, stating that HHS would give serious consideration to these recommendations. In regard to the current expedited review categories, SACHRP recommended that expedited review category 7 should be revised as described in Section V below. Therefore, in addition to requesting comments on the entire expedited review list that was published in the Federal Register on November 9, 1998 (63 FR 60364), OHRP is also specifically requesting comments on SACHRP's recommended revision of expedited review category 7. As required under 21 CFR 56.110(a), FDA also will publish in the Federal Register a list of categories of research that may be reviewed by the IRB through an expedited review procedure. FDA intends to issue the list concurrently with OHRP's issuance of its final notice, and in compliance with 21 CFR 10.115 (good guidance practice regulations). This approach maintains FDA's practice of moving in tandem on this issue with OHRP.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E7-21123
Type: Notice
Date: 2007-10-26
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Draft Guidance for Industry and Food and Drug Administration Staff; Impact-Resistant Lenses: Questions and Answers; Availability
Document Number: E7-21122
Type: Notice
Date: 2007-10-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Impact-Resistant Lenses: Questions and Answers.'' This draft guidance document answers manufacturer, importer, and consumer questions on impact-resistant lenses, including questions on test procedures, lens testing apparatus, record maintenance, and exemptions to testing.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E7-21116
Type: Notice
Date: 2007-10-26
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Submission for OMB Review; Comment Request; the Multi-Ethnic Study of Atherosclerosis (MESA) Event Surveillance
Document Number: E7-21103
Type: Notice
Date: 2007-10-26
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 National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval the information collection listed below. This proposed information collection was previously published in the Federal Register on August 21, 2007, pages 46640-46641, 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. 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: Title: The Multi-Ethnic Study of Atherosclerosis (MESA) Event Surveillance. Type of Information Collection Request: Renewal (OMB No. 0925-0493). Need and Use of Information Collection: This project identifies and quantifies factors associated with the presence and progression of subclinical cardiovascular disease (CVD)that is, atherosclerosis and other forms of CVD that have not produced signs and symptoms. The findings provide important information on subclinical CVD in individuals of different ethnic backgrounds and provide information for studies on new interventions to prevent CVD. The aspects of the study that concern direct participant evaluation received a clinical exemption from OMB clearance (CE-99-11-08) in April 2000. OMB clearance is being sought for the contact of physicians and participant proxies to obtain information about clinical CVD events that participants experience during the follow-up period. Frequency of Response: The participants will be contacted annually. Affected Public: Individuals or households; Businesses or other for profit; Small businesses or organizations. Type of Respondents: Individuals or households; physicians. The annual reporting burden is as follows: Estimated Number of Respondents: 550; Estimated Number of Responses per Respondent: 1.0; Average Burden Hours Per Response: .2; and Estimated Total Annual Burden Hours Requested: 36.7. The annualized cost to respondents is estimated at $5,595, assuming respondents time at the rate of $18.65 per hour and physician time at the rate of $75 per hour. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.
Government-Owned Inventions; Availability for Licensing
Document Number: E7-21100
Type: Notice
Date: 2007-10-26
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. 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.
Exocrine Pancreatic Insufficiency Drug Products; Extension to Obtain Marketing Approval
Document Number: E7-21082
Type: Notice
Date: 2007-10-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that it intends to continue to exercise enforcement discretion to ensure the continued availability of exocrine pancreatic insufficiency drug products after April 28, 2008. FDA intends to exercise its enforcement discretion with respect to unapproved pancreatic enzyme drug products until April 28, 2010, if the manufacturers have investigational new drug applications (INDs) on active status on or before April 28, 2008, and have submitted new drug applications (NDAs) on or before April 28, 2009. FDA is granting this extension to ensure the availability of exocrine pancreatic insufficiency drug products during the additional time needed by manufacturers to obtain marketing approval.
Medicare Program; Announcement of Meeting of the Advisory Panel on Medicare Education, December 4, 2007
Document Number: E7-21080
Type: Notice
Date: 2007-10-26
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, 5 U.S.C. Appendix 2, section 10(a) (Pub. L. 92-463), this notice announces a meeting of the Panel on December 4, 2007. The Panel advises and makes recommendations to the Secretary of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on opportunities to enhance the effectiveness of consumer education strategies concerning the Medicare program. This meeting is open to the public.
Notice of Public Meeting
Document Number: E7-21078
Type: Notice
Date: 2007-10-26
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 the following meeting on updating the NIOSH publication ``Occupational Exposure Sampling Strategies Manual''. The document can be found at https://www.cdc.gov/niosh/docs/77-173/. Instructions are provided for submitting comments. Public Meeting Dates and Times: November 8, 2007, 8:30 a.m. to 4:30 p.m. EST and November 9, 2007, 8:30 a.m. to 12 p.m. EST. Place: Washington Court Hotel, 525 New Jersey Avenue, NW., Washington, DC 20001. Purpose of Meeting: To obtain input from stakeholders on their needs for information and guidance to be included in a revision of the ``Occupational Exposure Sampling Strategies Manual'' (OESSM), which is sometimes referred to as ``Leidel, Busch and Lynch'' or ``The NIOSH Yellow Book'' [https://www.cdc.gov/niosh/77-173.html]. Status: The forum will include scientists and representatives from various government agencies, industry, labor, and other stakeholders, and is open to the public, limited only by the space available. Persons wanting to attend and contribute comments at the meeting are requested to register at https://www.team-psa.com/niosh-OESSM07/home.asp no later than November 1, 2007. Unreserved walk-in attendees will be accommodated on the day of the meeting if space is available. The meeting has several scheduled presentations and panels that will include time for questions and answers. In addition, two breakout sessions will be held to solicit discussion and input on specific occupational exposure issues. Presentations, questions, and oral comments given at the meeting will be recorded and included in the docket. Written comments will also be accepted at the meeting. Written comments may also be submitted to Diane Miller, Robert A. Taft Laboratories, 4676 Columbia Parkway, MS C- 34, Cincinnati, Ohio 45226, telephone 513/533-8611. All material submitted to the Agency should reference docket number NIOSH-091 and must be submitted by November 30, 2007 to be considered by the Agency. All electronic comments should be formatted as Microsoft Word. Please make reference to docket number NIOSH-091. NIOSH seeks to obtain materials, including published and unpublished reports and research findings, relevant to the current practice, limitations, and needs for development of occupational exposure assessment practices and policies. NIOSH will use this information to assess the needs and scientific basis for revisions to its guidance and recommendations in occupational exposure assessment. Contact Person for Technical Information: Paul Middendorf, telephone (513)533-8606, M/S C-9, Robert A. Taft Laboratories, 4676 Columbia Parkway, Cincinnati, Ohio 45226. Contact Person for Submitting Comments/Meeting Attendance: Diane Miller, Robert A. Taft Laboratories, 4676 Columbia Parkway, MS C-34, Cincinnati, Ohio 45226, telephone 513/533-8611. All material submitted to the Agency should reference docket number NIOSH-091. All information received in response to this notice will be available for public examination and copying at the NIOSH Docket Office, 4676 Columbia Parkway, Cincinnati, Ohio 45226.
Medicare and Medicaid Programs; Application by The Joint Commission for Continued Deeming Authority for Home Health Agencies
Document Number: E7-20579
Type: Notice
Date: 2007-10-26
Agency: Department of Health and Human Services, Centers for Medicare and Medicaid Services, Centers for Medicare & Medicaid Services
This proposed notice with comment period acknowledges the receipt of a deeming application from The Joint Commission for continued recognition as a national accrediting organization for home health agencies that wish to participate in the Medicare or Medicaid programs. Section 1865(b)(3)(A) of the Social Security Act requires that within 60 days of receipt of an organization's complete application, we publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
Medicare and Medicaid Programs; Application by the Community Health Accreditation Program for Continued Deeming Authority for Home Health Agencies
Document Number: E7-20574
Type: Notice
Date: 2007-10-26
Agency: Department of Health and Human Services, Centers for Medicare and Medicaid Services, Centers for Medicare & Medicaid Services
This proposed notice with comment period acknowledges the receipt of a deeming application from the Community Health Accreditation Program for continued recognition as a national accrediting organization for home health agencies that wish to participate in the Medicare or Medicaid programs. Section 1865(b)(3)(A) of the Social Security Act requires that within 60 days of receipt of an organization's complete application, we publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
Medicare Program: Approval of Application by the American Diabetes Association (ADA) for Continued Recognition as a National Accreditation Organization That Accredits Entities To Furnish Outpatient Diabetes Self-Management Training
Document Number: E7-20495
Type: Notice
Date: 2007-10-26
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final notice announces the approval of the American Diabetes Association (ADA) as a national accreditation organization for the purpose of determining that an entity meets the necessary quality standards to furnish outpatient diabetes self-management training services under Part B of the Medicare program. Therefore, diabetes self-management training (DSMT) programs accredited by the ADA will receive deemed status under the Medicare program.
Medicare Program; Meeting of the Practicing Physicians Advisory Council, December 3, 2007
Document Number: E7-20484
Type: Notice
Date: 2007-10-26
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces a quarterly meeting of the Practicing Physicians Advisory Council (the Council). The Council will meet to discuss certain proposed changes in regulations and manual instructions related to physicians' services, as identified by the Secretary of Health and Human Services (the Secretary). This meeting is open to the public.
National Institute of Mental Health; Notice of Meeting
Document Number: 07-5314
Type: Notice
Date: 2007-10-26
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Research Resources; Notice of Closed Meetings
Document Number: 07-5313
Type: Notice
Date: 2007-10-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 07-5312
Type: Notice
Date: 2007-10-26
Agency: Department of Health and Human Services, National Institutes of Health
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