Notices. Notice
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/register/2008/02/20/08-746A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4160-90-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-08-0138] Proposed Data Collections Submitted for Public Comment and Recommendations In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention
(CDC)will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404-639-5960 or send comments to Maryam Daneshvar, CDC Assistant Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to *omb@cdc.gov* . Comments are invited on:
(a)Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;
(b)the accuracy of the agency's estimate of the burden of the proposed collection of information;
(c)ways to enhance the quality, utility, and clarity of the information to be collected; and
(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice. Proposed Project Pulmonary Function Testing Course Approval Program, 29 CFR 1910.1043 (OMB No. 0920-0138)—Reinstatement—The National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC). Background NIOSH has the responsibility under the Occupational Safety and Health Administration's Cotton Dust Standard, 29 CFR 1920.1043, for approving courses to train technicians to perform pulmonary function testing in the cotton industry. Successful completion of a NIOSH-approved course is mandatory under the Standard. To carry out its responsibility, NIOSH maintains a Pulmonary Function Testing Course Approval Program. The program consists of an application submitted by potential sponsors (universities, hospitals, and private consulting firms) who seek NIOSH approval to conduct courses, and if approved, notification to NIOSH of any course or faculty changes during the approval period, which is limited to five years. The application form and added materials, including an agenda, curriculum vitae, and course materials are reviewed by NIOSH to determine if the applicant has developed a program which adheres to the criteria required in the Standard. Following approval, any subsequent changes to the course are submitted by course sponsors via letter or e-mail and reviewed by NIOSH staff to assure that the changes in faculty or course content continue to meet course requirements. Course sponsors also voluntarily submit an annual report to inform NIOSH of their class activity level and any faculty changes. Sponsors who elect to have their approval renewed for an additional 5 year period submit a renewal application and supporting documentation for review by NIOSH staff to ensure the course curriculum meets all current standard requirements. Approved courses that elect to offer NIOSH-Approved Spirometry Refresher Courses must submit a separate application and supporting documents for review by NIOSH staff. Institutions and organizations throughout the country voluntarily submit applications and materials to become course sponsors and carry out training. Submissions are required for NIOSH to evaluate a course and determine whether it meets the criteria in the Standard and whether technicians will be adequately trained as mandated under the Standard. There will be no cost to respondents other than their time. Estimated Annualized Burden Hours Forms for respondents Number of respondents Number of responses/ respondent Average burden/ response (in hrs) Total burden (in hours) Initial Application 3 1 3.5 11 Annual Report 35 1 30/60 18 Report for Course Changes 12 1 45/60 9 Renewal Application 13 1 6.0 78 Refresher Course Application 10 1 8.0 80 Total 196 Dated: February 11, 2008. Maryam I. Daneshvar, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E8-3076 Filed 2-19-08; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60 Day-08-0488] Proposed Data Collections Submitted for Public Comment and Recommendations In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention
(CDC)will publish periodic summaries of proposed projects. Alternatively, to obtain a copy of the data collection plans and instrument, call 404-639-5960 and send comments to Maryam I. Daneshvar, Acting CDC Reports Clearance Officer, 1600 Clifton Road, NE., MS-D74, Atlanta, Georgia 30333; comments may also be sent by e-mail to *omb@cdc.gov* . Comments are invited on
(a)whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have a practical utility;
(b)the accuracy of the agency's estimate of the burden of the proposed collection of information;
(c)ways to enhance the quality, utility, and clarity of the information to be collected; and
(d)ways to minimize the burden of the collection of information on respondents, including through the use of information technology. Written comments should be received within 60 days of this notice. Proposed Project Restriction on Travel of Persons (OMB Control No. 0920-0488)—Reinstatement—National Center for Preparedness, Detection, and Control of Infectious Diseases (NCPDCID), Centers for Disease Control and Prevention (CDC). Background and Brief Description The Centers for Disease Control and Prevention is requesting OMB approval to reinstate without change the information collection request, “Restriction on Travel of Persons” (OMB Control No. 0920-0488). This information collection request expired on March 31, 2007. CDC is authorized to collect this information under 42 CFR 70.5 (Certain communicable diseases; special requirements). This regulation requires that any person who is in the communicable period for cholera, plague, smallpox, typhus, or yellow fever or having been exposed to any such disease is in the incubation period thereof, to apply for and receive a permit from the Surgeon General or his authorized representative in order to travel from one State or possession to another. Control of disease transmission within the States is considered to be the province of state and local health authorities, with Federal assistance being sought by those authorities on a cooperative basis without application of Federal regulations. The regulations in 42 part 70 were developed to facilitate Federal action in the event of large outbreaks requiring a coordinated effort involving several states, or in the event of inadequate local control. While it is not known whether, or to what extent situations may arise in which these regulations would be invoked, contingency planning for domestic emergency preparedness is now commonplace. Should these situations arise, CDC will use the reporting and recordkeeping requirements contained in the regulations to carry out quarantine responsibilities as required by law. There is no cost to respondents other than their time. Estimate of Annualized Burden Hours Regulation Respondent Number of respondents Number of responses per respondent Average burden per response (in hours) Total burden (in hours) 42 CFR 70.3 Application to the State of Destination for a permit Traveler 2,000 1 15/60 500 Attending physician 2,000 1 15/60 500 42 CFR 70.3 Copy of material submitted by applicant and permit issued by State health authority State health authority 8 250 6/60 200 42 CFR 70.4 Report by the master of a vessel or person in charge of conveyance of the incidence of a communicable disease occurring while in interstate travel Master of a vessel or person in charge of conveyance 1,500 1 15/60 375 42 CFR 70.4 Copy of material submitted or state or local health authority under this provision State health authority 20 75 6/60 150 42 CFR 70.5 Application for a permit to move from State to State while in the communicable period Traveler 3,750 1 15/60 937.5 Attending physician 3,750 1 15/60 937.5 Total 3,600 Dated: February 13, 2008. Maryam I. Daneshvar, Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E8-3077 Filed 2-19-08; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Notice of Public Meeting AGENCY: The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). SUMMARY: The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention
(CDC)announces the following public meeting: Partnerships to Advance the National Occupational Research Agenda (NORA)”. *Public Meeting Time and Date:* 9 a.m.-3 p.m. EST, February 27, 2008. *Place:* Patriots Plaza, 395 E Street SW., Conference Room 9000, Washington, DC 20201. *Purpose of Meeting:* NORA has been structured to engage partners with each other and/or with NIOSH to advance NORA priorities. The NORA Liaison Committee continues to be an opportunity for representatives from organizations with national scope to learn about NORA progress and to suggest possible partnerships based on their organization's mission and contacts. This opportunity is now able to be structured as a public meeting via the Internet in order to attract participation by a larger number of organizations and to enhance the success of NORA. Some of the types of organizations of national scope that are especially encouraged to participate are employers, unions, trade associations, labor associations, professional associations, and foundations. Others are welcome. This meeting will include updates from NIOSH leadership on NORA as well as updates from approximately half of the Councils on their progress, priorities and implementation plans to date, including the Agriculture, Forestry and Fishing Sector; Healthcare and Social Assistance Sector; Transportation, Warehousing and Utilities Sector; Mining Sector and Oil and Gas Extraction Sub-Sector. After each update, there will be time to discuss partnership opportunities. *Status:* The meeting is open to the public, limited only by the capacities of the conference call and conference room facilities. There is limited space available in the meeting room (capacity 34). Therefore, information to allow participation in the meeting through the internet (to see the slides) and a teleconference call (capacity 50) will be provided to registered participants. Participants are encouraged to consider attending by this method. Each participant is requested to register for the free meeting by sending an E-mail to *noracoordinator@cdc.gov* containing the participant's name, organization name, contact phone number on the day of the meeting, and preference for participation by web meeting (requirements include: Computer, internet connection and phone, preferably with “mute” capability) or in person. An E-mail confirming registration will include the details needed to participate in the web meeting. Non-U.S. citizens are encouraged to participate in the web meeting. Non-U.S. citizens registering to attend in person after February 15 will not have time to comply with security procedures. *Background:* The National Occupational Research Agenda
(NORA)is a partnership program to stimulate innovative research in occupational safety and health leading to improved workplace practices. Unveiled in 1996, NORA has become a research framework for the nation. Diverse parties collaborate to identify the most critical issues in workplace safety and health. Partners then work together to develop goals and objectives for addressing those needs and to move the research results into practice. The NIOSH role is facilitator of the process. For more information about NORA, see *http://www.cdc.gov/niosh/nora/about.html.* Since 2006, NORA has been structured by industrial sectors. Eight sector groups have been defined using the North American Industrial Classification System (NAICS). After receiving public input through the web and town hall meetings, NORA Sector Councils have been working to define sector-specific strategic plans for conducting research and moving the results into widespread practice. During 2008, most of these Councils will post draft strategic plans for public comment. For more information, see the link above and choose “Sector-based Approach,” “NORA Sector Councils” and “Comment on Draft Sector Agendas” from the right-side menu. *Contact Person for Technical Information:* Sidney C. Soderholm, Ph.D., NORA Coordinator, http://www.noracoordinator@cdc.gov,
(202)245-0665. Dated: February 12, 2008. James D. Seligman, Chief Information Officer, Centers for Disease Control and Prevention. [FR Doc. E8-3071 Filed 2-19-08; 8:45 am] BILLING CODE 4163-19-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0053] Draft Guidance for Industry on Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing the availability of a draft guidance for industry entitled “Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices.” The draft guidance provides drug, biologics, and device manufacturers with the agency's views on the distribution of medical journal articles and scientific or medical reference publications that discuss unapproved new uses for FDA approved drugs or biologics or FDA approved or cleared medical devices to health care professionals and health care entities. DATES: Submit written or electronic comments on the draft guidance by April 21, 2008. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the draft guidance to the Office of Policy (HF-11), Office of Commissioner, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive label to assist that office in processing your requests. Submit electronic requests for copies of the draft guidance to *http://www.fda.gov/oc/op/goodreprint.html* . Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.regulations.gov* . See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Jarilyn Dupont, Office of Policy, Office of Commissioner, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3360. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled “Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices.” The draft guidance provides drug, biologics, and device manufacturers with the agency's views on the distribution of medical journal articles and scientific or medical reference publications that discuss unapproved new uses for FDA approved drugs (including biologics) or FDA approved or cleared medical devices to health care professionals and health care entities. On September 30, 2006, section 401 of the Food and Drug Administration Modernization Act (FDAMA) (section 551 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360aaa)) ceased to be in effect. The provision described certain conditions under which a drug or medical device manufacturer could disseminate medical and scientific information discussing unapproved uses of approved drugs and cleared or approved medical devices to health care professionals and certain entities (including pharmacy benefits managers, health insurance issuers, group health plans, and Federal or State governmental agencies). Section 401 of FDAMA provided that, if the described conditions were met, dissemination of such journal articles or reference publications would not be considered as evidence of the manufacturer's intent that the product be used for an unapproved new use. FDA implementing regulations were codified at 21 CFR part 99. In light of the sunset of section 401 of FDAMA and in recognition of the public health value to health care professionals of receiving scientific and medical information, FDA is providing its current views and recommendations concerning “Good Reprint Practices” for the dissemination of medical journal articles and medical or scientific reference publications on unapproved uses of drugs and medical devices. FDA's legal authority to determine whether distribution of medical or scientific information constitutes promotion of an unapproved “new use,” or whether such activities cause a product to be misbranded or adulterated has not changed. This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency's current thinking on the dissemination of medical journal articles and medical or scientific reference publications on unapproved uses of approved drugs and approved or cleared medical devices to health care professionals and health care entities. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Please note that as of January 15, 2008, the FDA Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic submissions will be accepted by FDA only through FDMS. III. Electronic Access Persons with access to the Internet may obtain the document at *http://www.fda.gov/ohrms/dockets/default.htm* . Dated: February 13, 2008. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 08-746 Filed 2-15-08; 8:45 am]
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6 references not yet in our index
- 29 CFR 1920.1043
- 42 CFR 70.5
- 42 CFR 70.3
- 42 CFR 70.4
- 21 USC 360aaa
- 21 CFR 99
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Notices
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Cite29 CFR 1920.1043
Cite42 CFR 70.5
Cite42 CFR 70.3
Cite42 CFR 70.4
Cite21 USC 360aaa
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