Department of Health and Human Services September 23, 2008 – Federal Register Recent Federal Regulation Documents
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Submission for Proposed Collection Comment Request: The Effectiveness of the NIH Curriculum Supplements Programs
In compliance with the requirements 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 Science Education, 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: The Effectiveness of the NIH Curriculum Supplements Programs Survey. Information Collection Request: New. Need and Use of Information Collection: The survey will attempt to assess customer demographics and their satisfaction with the NIH curriculum supplements in presenting science in a more engaging and interactive way. The supplements help K-12 educators teach science by featuring the latest NIH research and utilized research-based instructional methods. A typical supplement contains two weeks of student activities on the science behind a health topic, such as cancer, sleep or obesity. Web-based simulations, animations and experiments enhance the ``pencil and paper'' activities. In addition to developing and distributing the supplements, OSE conducts professional workshops to help teachers successfully implement these lessons with their students. Since January 2000, over 6,000 teachers have attended an OSE workshop. Assessing the effectiveness of the NIH curriculum supplements and teacher workshops is critical to determining if OSE is successfully fulfilling its mission. OSE has the database infrastructure in place to easily collect data from supplement requesters and workshop attendees. At present, we do not have clearance to contact our customers to determine how NIH resources are meeting their educational needs.
Ophthalmic Balanced Salt Solutions for Ocular Surgical Procedures; Enforcement Action Dates
The Food and Drug Administration (FDA) is announcing its intention to take enforcement action against unapproved ophthalmic balanced salt solutions for irrigation of the eye during surgery and persons\1\ who manufacture or cause the manufacture of such products or their shipment in interstate commerce. Unapproved ophthalmic balanced salt solutions have been associated with adverse events, some of them leading to permanent loss of visual acuity, because of contamination of the product or other product defects. Ophthalmic balanced salt solutions are new drugs that require approved applications because they are not generally recognized as safe and effective. Two firms have approved applications to market these products. Manufacturers who wish to market ophthalmic balanced salt solutions must obtain FDA approval of a new drug application (NDA) or an abbreviated new drug application (ANDA).
Topical Drug Products Containing Papain; Enforcement Action Dates
The Food and Drug Administration (FDA) is announcing its intention to take enforcement action against unapproved topical drug products containing papain and persons\1\ who manufacture or cause the manufacture of such products or their shipment in interstate commerce. Topical drug products containing papain are marketed, without approved applications, to debride necrotic tissue and liquefy slough in acute and chronic lesions. Potentially serious adverse events have been reported with topical drug products containing papain. Topical drug products containing papain are new drugs that require approved applications because they are not generally recognized as safe and effective. Currently no firm has an approved application to market a topical drug product containing papain. Manufacturers who wish to market topical drug products containing papain must obtain FDA approval of a new drug application (NDA) or an abbreviated new drug application (ANDA).
Review of NIOSH Draft Current Intelligence Bulletin, “A Strategy for Assigning the New NIOSH Skin Notations for Chemicals”
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) is conducting a public review of the NIOSH document ``CIB: A Strategy for Assigning the New NIOSH Skin Notations for Chemicals.'' This draft Current Intelligence Bulletin (CIB) was developed to provide the scientific rationale and framework for a strategy for the assignment of multiple skin notations capable of distinguishing between systemic, localized, and sensitizing health effects of dermal chemical exposures. The strategy has been designed to (1) communicate the current state of knowledge on hazards to workers' health from dermal exposures, (2) address the conceptual shortcomings of the current NIOSH skin notation represented by the symbol [skin], (3) recognize the health risks associated with contact of the skin with chemicals beyond dermal absorption, and (4) increase the transparency of the process for assigning the new NIOSH skin notations. The CIB can be found at: https://www.cdc.gov/niosh/ review/public/109. Public Meeting Time and Date: 9 a.m.-4 p.m. EDT, November 6, 2008. Place: NIOSH, Robert A. Taft Laboratories, Taft Auditorium, 4676 Columbia Parkway, Cincinnati, Ohio 45226. 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 (the room accommodates approximately 80 people). Due to limited space, notification of intent to attend the meeting must be made to the NIOSH Docket Officer, no later than October 22, 2008. The NIOSH Docket Officer can be reached at (513) 533-8611 or by e-mail at niocindocket@cdc.gov. Requests to attend the meeting will be accommodated on a first-come basis. Non-U.S. Citizens: Because of CDC Security Regulations, any non- U.S. citizen wishing to attend this meeting must provide the following information in writing to the NIOSH Docket Officer at the address below no later than October 15, 2008. 1. Name: 2. Gender: 3. Date of Birth: 4. Place of Birth (city, province, state, country): 5. Citizenship: 6. Passport Number: 7. Date of Passport Issue: 8. Date of Passport Expiration: 9. Type of Visa: 10. U.S. Naturalization Number (if a naturalized citizen): 11. U.S. Naturalization Date (if a naturalized citizen): 12. Visitor's Organization: 13. Organization Address: 14. Organization Telephone Number: 15. Visitor's Position/Title within the Organization: This information will be transmitted to the CDC Security Office for approval. Visitors will be notified as soon as approval has been obtained. Purpose of the Meeting: To discuss and obtain comments on the draft CIB, ``A Strategy for Assigning the New NIOSH Skin Notations for Chemicals.'' Special emphasis will be placed on discussion of the following issues: 1. Are the proposed classes of skin notations appropriate? 2. Are the proposed criteria for assigning each type of skin notation appropriate? 3. Is the proposed assignment of multiple skin notations useful for protecting workers from dermal hazards? 4. Should the sensitizing effects (SEN) notation apply strictly to allergic contact dermatitis or is it appropriate to assign the SEN notation for other immune-mediate responses, such as respiratory sensitization, airway hyperactivity and mucosal inflammation, associated with dermal exposure to a compound? 5. Does the proposed harmonization scheme found in Appendix G.2 link the new NIOSH skin notations and The Globally Harmonized System of Classification and Labeling of Chemicals (GHS) assignments sufficiently? 6. Should additional information be included within document? If so, what? 7. Do the data cited support the objectives of the document? 8. Are the conclusions appropriate in light of the current understanding of the toxicological data? This document may be found at: https://www.cdc.gov/niosh/review/ public/109/. Written comments may be submitted to the NIOSH Docket Officer, Robert A. Taft Laboratories, 4676 Columbia Parkway, M/S C-34, Cincinnati, OH 45226, telephone (513) 533-8611, facsimile (513) 533- 8230. Comments may also be submitted via e-mail to niocindocket@cdc.gov. All electronic comments should be formatted as Microsoft Word. Comments must be submitted to NIOSH no later than November 7, 2008, and should reference docket number NIOSH-109 in the subject heading. Oral comments made at the public meeting must also be submitted to the docket in writing in order to be considered by the Agency. 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. Contact Person for Technical Information: Scott Dotson, Industrial Hygienist, NIOSH, CDC, telephone (513) 533-8540, M/S C-32, Robert A. Taft Laboratories, 4676 Columbia Parkway, Cincinnati, Ohio 45226.
National Vaccine Injury Compensation Program List of Petitions Received
The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (``the Program''), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
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