September 17, 2010 – Federal Register Recent Federal Regulation Documents

The Consumer Product Safety Commission (``CPSC'' or ``Commission'') 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.

This action adds a product and a service to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities, and deletes products and services from the Procurement List previously furnished by such agencies.

This notice amends the notice of a major disaster declaration for the State of Iowa (FEMA-1928-DR), dated July 27, 2010, and related determinations.

Notice is hereby given that NMFS has received three scientific research permit application requests relating to Pacific salmon. The proposed research is intended to increase knowledge of species listed under the Endangered Species Act (ESA) and to help guide management and conservation efforts. The applications may be viewed online at: https://apps.nmfs.noaa.gov/preview/previewopenfor comment.cfm

NMFS issues regulations amending the limited access program for charter vessels in the guided sport fishery for Pacific halibut in the waters of International Pacific Halibut Commission Regulatory Area 2C (Southeast Alaska) and Area 3A (Central Gulf of Alaska). These regulations revise the method of assigning angler endorsements to charter halibut permits to more closely align each endorsement with the greatest number of charter vessel anglers reported for each vessel that a charter business used to qualify for a charter halibut permit. This action is necessary to achieve the halibut fishery management goals of the North Pacific Fishery Management Council.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for the opportunity for public comment on proposed data collection projects, the National Institute on Aging (NIA), 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: Recruitment and Screening for the Insight into Determination of Exceptional Aging and Longevity (IDEAL) Study. Type of Information Collection Request: NEW. Need and Use of Information Collection: The purpose of the project for is to conduct recruitment and screening for the IDEAL Study. A multifaceted recruitment approach will be used to reach the target audience in a wide variety of ways. Those who are interested in participating in the IDEAL study will be asked to complete a two stage recruitment process consisting of a telephone interview and a physical exam. The Stage One interview consists of questions concerning demographics, physical ability, health status, and medical conditions. Those who are eligible after completing the telephone interview will be asked to complete the second stage of the screening process. The physical examination is a modified version of the full BLSA assessment protocol consisting of the following components: general appearance; vital signs; chest and heart auscultation; sensory systems including vision, hearing, sensory proprioception, neuropathy and balance; and movement and strength of the upper and lower extremities. In addition the potential participant will also be asked to complete physical performance tests, cognitive exams, an electrocardiogram and a blood draw. Frequency of Response: Once. Affected Public: Individuals or households. Type of Respondents: Healthy individuals who are at least 80 years of age. The annual reporting burden is as follows: Estimated Number of Respondents: 1,500; Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: 0.833; and Estimated Total Annual Burden Hours Requested: 701. There is no annualized cost to respondents. There are no Capital costs to report. There are no Operating or Maintenance Costs to report.

NMFS proposes a regulation to implement the annual harvest guideline (HG) for Pacific mackerel in the U.S. exclusive economic zone (EEZ) off the Pacific coast. This HG is proposed according to the regulations implementing the Coastal Pelagic Species (CPS) Fishery Management Plan (FMP) and establishes allowable harvest levels for Pacific mackerel off the Pacific coast. The proposed total HG for the 2010-2011 fishing year is 11,000 metric tons (mt) and is proposed to be divided into a directed fishery HG of 8,000 mt and an incidental fishery of 3,000 mt.

The Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) are considering establishing a process for overlapping evaluations of premarket, FDA-regulated medical products when the product sponsor and both agencies agree to such parallel review. This process will serve the public interest by reducing the time between FDA marketing approval or clearance decisions and CMS national coverage determinations (NCDs). The agencies are establishing a docket to receive information and comment from the public on what products would be appropriate for parallel review by the two agencies, what procedures should be developed, how a parallel review process should be implemented, and other issues related to the effective operation of the process. The agencies are also announcing their intent to create a pilot program for parallel review of medical devices. The pilot program will begin after both agencies have reviewed the public comments on this notice. A memorandum of understanding (MOU) concerning the exchange of data and information has been completed between the two agencies. See https://www.fda.gov/AboutFDA/ PartnershipsCollaborations/MemorandaofUnderstandingMOUs/Domes ticMOUs/ ucm217585.htm.

We are proposing to amend the live animal export regulations by removing the list of designated ports of embarkation and their associated export inspection facilities. As a result of this rulemaking, those ports and facilities would henceforth be listed on the Internet rather than in the regulations, thus enabling us to amend the list, when necessary, in a timelier manner than we can now and allowing us greater flexibility in regulating animal exports.

We, the U.S. Fish and Wildlife Service (Service), intend to prepare a comprehensive conservation plan (CCP) for Camas National Wildlife Refuge (refuge) in Hamer, ID. We will also prepare an environmental assessment (EA) to evaluate the potential effects of various CCP alternatives. We are providing this notice in compliance with our CCP policy to advise the public, Federal and State agencies, and Tribes of our intentions, and to obtain suggestions and information on the scope of issues to consider during the CCP planning process.

HHS gives notice of a decision to designate a class of employees from the Blockson Chemical Company in Joliet, Illinois, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On September 3, 2010, the Secretary of HHS designated the following class of employees as an addition to the SEC:

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the publication of the following document entitled ``NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2010.'' The document can be found at https://www.cdc.gov/niosh/docs/2010-167/. Background: The NIOSH Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings was published in September 2004 (https://www.cdc.gov/niosh/docs/2004-165/). From that time until June 2007, approximately 60 new drugs have received FDA approval and approximately 60 drugs have received special warnings (usually black box warnings) based on reported adverse effects in patients. An additional 18 drugs were included from the updated NIH Hazardous Drug List. From this list of approximately 150 drugs, 62 drugs were determined to have one or more characteristic of a hazardous drug and published for comment in NIOSH Docket Number 105. After expert panel review, public review and comment, input from stakeholders and review of the scientific literature NIOSH proposed a second, draft list of hazardous drugs that was published in NIOSH Docket 105A. The second, draft list identified 24 drugs that fit the NIOSH definition of hazardous drugs. The second draft list also proposed removing Bacillus Calmette-Guerin (BCG), based on additional comments received by NIOSH. Following the second Federal Register Notice, BCG was reinstated to the list and a total of 21 new drugs were added to the 2004 list in Appendix A of the Alert. This guidance document does not have the force and effect of law.

In accordance with the Federal Advisory Committee Act, Public Law 92-463, as amended, the National Aeronautics and Space Administration (NASA) announces a meeting for the Information Technology Infrastructure Committee of the NASA Advisory Council (NAC).

The U.S. Fish and Wildlife Service (Service) announces the availability of a draft revised recovery plan for the Utah prairie dog (Cynomys parvidens). This species is federally listed as threatened under the Endangered Species Act of 1973, as amended (Act). The Service solicits review and comment from the public on this draft revised plan.

The Office of Personnel Management (OPM), Human Resources Solutions Division, offers the general public and other Federal agencies the opportunity to comment on an existing information collection request (ICR) 3206-0246, SFS Registration. As required by the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. chapter 35), as amended by the Clinger-Cohen Act (Pub. L. 104-106), OPM is soliciting comments for this collection. The information collection was previously published in the Federal Register on April 19, 2010 at 75 FR 20400, allowing for a 60-day public comment period. One comment was received, and OPM provided a response. The purpose of this notice is to allow an additional 30 days for public comments. The Office of Management and Budget is particularly interested in comments that: 1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; 2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; 3. Enhance the quality, utility, and clarity of the information to be collected; and 4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses.