Department of Health and Human Services October 26, 2007 – Federal Register Recent Federal Regulation Documents
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Medicare Program; Hospital Conditions of Participation: Requirements for Approval and Re-Approval of Transplant Centers To Perform Organ Transplants
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
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.
Draft Guidance for Industry and Food and Drug Administration Staff; Impact-Resistant Lenses: Questions and Answers; Availability
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.
Submission for OMB Review; Comment Request; the Multi-Ethnic Study of Atherosclerosis (MESA) Event Surveillance
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
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
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
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
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
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
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
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
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.
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