Notices. Notice

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BILLING CODE 4154-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N-0486] Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Public Health Notification (formerly known as Safety Alert/Public Health Advisory) Readership Survey AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on FDA Public Health Notification (formerly known as Safety Alert/Public Health Advisory) Readership Survey. DATES: Submit written or electronic comments on the collection of information by February 21, 2006. ADDRESSES: Submit electronic comments on the collection of information to: *http://www.fda.gov/dockets/ecomments* . Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget

(OMB)for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics:

(1)Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;

(2)the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(3)ways to enhance the quality, utility, and clarity of the information to be collected; and

(4)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. FDA Public Health Notification (formerly known as Safety Alert/Public Health Advisory) Readership Survey (OMB Control Number 0910-0341)—Extension Section 705(b) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 375(b)) authorizes FDA to disseminate information concerning imminent danger to public health by any regulated product. The Center for Devices and Radiological Health

(CDRH)communicates these risks to user communities through two publications:

(1)The Public Health Notification

(PHN)and

(2)the Preliminary Public Health Notification (PPHN). The PHN is published when CDRH has information or a message to convey to health care practitioners that they would want to know in order to make informed clinical decisions about the use of a device or device type, and that information may not be readily available to the affected target audience in the health care community, and CDRH can make recommendations that will help the health care practitioner mitigate or avoid the risk. The PPHN is also published when CDRH has information to convey to health care practitioners that they would want to know in order to make informed clinical decisions about the use of a device or device type. However, two additional conditions exist that make the use of this type of notification preferable. First, CDRH's understanding of the problem, its cause(s), and the scope of the risk is still evolving, and in order to minimize the risk, the center believes that health care practitioners need the information they have, however incomplete, as soon as possible. Second, the problem is being actively investigated by the center, the industry, another agency or some other reliable entity, so that the center expects to be able to update the PPHN when definitive new information becomes available. Notifications are sent to organizations affected by the risks discussed in the notification such as hospitals, nursing homes, hospices, home health care agencies, retail pharmacies, and other health care providers. Through a process for identifying and addressing postmarket safety issues related to regulated products, CDRH determines when to publish notifications. Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 300u(a)(4) authorizes FDA to conduct research relating to health information. FDA seeks to evaluate the clarity, timeliness, and impact of safety alerts and public health advisories by surveying a sample of recipients. Subjects will receive a questionnaire to be completed and returned to FDA. The information to be collected will address how clearly notifications for reducing risk are explained, the timeliness of the information, and whether the reader has taken any action to eliminate or reduce risk as a result of information in the alert. Subjects will also be asked whether they wish to receive future notifications electronically, as well as how the PHN program might be improved. The information collected will be used to shape FDA's editorial policy for the PHN and PPHN. Understanding how target audiences view these publications will aid in deciding what changes should be considered in their content, format, and method of dissemination. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 No. of respondents Annual Frequency per response Total Annual responses Hours per response Total hours 308 3 924 .17 157 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Based on the history of the PHN program, it is estimated that an average of three collections will be conducted a year. The total burden of response time is estimated at 10 minutes per survey. This was derived by CDRH staff completing the survey and through discussions with the contacts in trade organizations. Dated: December 8, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E5-7642 Filed 12-21-05; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005D-0274] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Hazard Analysis and Critical Control Point Manuals for Operators and Regulators of Retail and Food Service Establishments AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)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. DATES: Fax written comments on the collection of information by January 23, 2006. ADDRESSES: OMB is still experiencing significant delays in the regular mail, including first class and express mail, and messenger deliveries are not being accepted. To ensure that comments on the information collection are received, OMB recommends that comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, Desk Officer for FDA, FAX: 202-395-6974. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Voluntary Hazard Analysis and Critical Control Point (HACCP) Manuals for Operators and Regulators of Retail and Food Service Establishments The draft Operator's Manual contains information and recommendations for operators of retail and foodservice establishments who wish to develop and implement a voluntary food safety management system based on HACCP principles. Operators may decide to incorporate some or all of the principles presented in the draft manual into their existing food safety management systems. The recordkeeping practices discussed in the draft manual are voluntary and may include documenting certain activities, such as monitoring and verification, which the operator may or may not deem necessary to ensure food safety. The draft manual includes optional worksheets to assist operators in developing and validating a voluntary food safety management system. The draft Regulator's Manual contains recommendations for State, local, and tribal regulators on conducting risk-based inspections of retail and foodservice establishments, including recommendations about recordkeeping practices that can assist operators in preventing foodborne illness. These recommendations may lead to voluntary actions by operators based on consultation with regulators. For example, an operator may develop a risk control plan as an intervention strategy for controlling specific out-of-control foodborne illness risk factors identified during an inspection. Further, the draft manual contains recommendations to assist regulators when evaluating voluntary food safety management systems in retail and foodservice establishments. Such evaluations typically consist of the following two components: Validation (assessing whether the establishment's voluntary food safety management system is adequate to control food safety hazards) and verification (assessing whether the establishment is following its voluntary food safety management system). The draft manual includes a sample “Verification Inspection Checklist” to assist regulators when conducting verification inspections of establishments with voluntary food safety management systems. Types of operator records discussed in the manuals and listed in the following burden estimates include: Food safety management systems (plans that delineate the formal procedures to follow to control all food safety hazards in an operation); risk control plans (HACCP-based, goal-oriented plans for achieving active managerial control over specific out-of-control foodborne illness risk factors); hazard analysis (written assessment of the significant food safety hazards associated with foods prepared in the establishment); prerequisite programs (written policies or procedures, including but not limited to, standard operating procedures, training protocols, and buyer specifications that address maintenance of basic operational and sanitation conditions); monitoring (records showing the observations or measurements that are made to help determine if critical limits are being met and maintained); corrective action (records indicating the activities that are completed whenever a critical limit is not met); ongoing verification (records showing the procedures that are followed to ensure that monitoring and other functions of the food safety management system are being implemented properly); and validation (records indicating that scientific and technical information is collected and evaluated to determine if the food safety management system, when properly implemented, effectively controls the hazards). All recommendations in both manuals are voluntary. For simplicity and to avoid duplicate estimates for operator recordkeeping practices that are discussed in both manuals, the burden for all collection of information recommendations for retail and foodservice operators are estimated together in table 1 of this document, regardless of the manual in which they appear. Collection of information recommendations for regulators in the Regulator's Manual are listed separately in table 2 of this document. The likely respondents to this collection of information are operators and regulators of retail and foodservice establishments. In the **Federal Register** of July 21, 2005 (70 FR 42072), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. FDA estimates the burden of the collection of information as follows: **Table 1.—Estimated Annual Recordkeeping Burden for Operators** 1 Types of Records No. of Recordkeepers Annual Frequency of Recordkeeping Total Annual Records Hours per Recordkeeper Total Hours Food Safety Management System 50,000 2 1 50,000 60 3,000,000 Hazard Analysis 50,000 2 1 50,000 20 1,000,000 Prerequisite Program Records 100,000 3 365 36,500,000 0.1 3,650,000 Monitoring Records 100,000 3 365 36,500,000 0.3 10,950,000 Corrective Action Records 100,000 3 365 36,500,000 0.1 3,650,000 Ongoing Verification Records (includes calibration records) 100,000 3 365 36,500,000 0.1 3,650,000 Validation Records 50,000 3 1 50,000 4 200,000 Total First Year Burden 4 : 26,100,000 Annual Burden 4 : 22,100,000 Risk Control Plan 50,000 1 50,000 2 100,000 Monitoring Records 100,000 90 9,000,000 0.3 2,700,000 Corrective Action Records 100,000 90 9,000,000 0.1 900,000 Ongoing Verification Records (includes calibration records) 100,000 90 9,000,000 0.1 900,000 Annual Burden 5 4,600,000 Total Annual Burden for Operators (Excluding First Year) 26,700,000 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 First year burden only. 3 Annual burden. 4 Burden for developing and implementing a food safety management system based on the Operator's Manual. 5 Annual burden for developing and implementing a risk control plan based on the Regulator's Manual. The burden for these activities may vary among retail and foodservice operators depending on the type and number of products involved, the complexity of an establishment's operation, the nature of the equipment or instruments required to monitor critical control points, and the extent to which an operator uses the Operator's Manual and/or the Regulator's Manual. The estimate does not include collections of information that are a usual and customary part of an operator's normal activities. FDA has established as a goal to have 50,000 (1/2 of 1 percent) of the approximately one million U.S. retail and foodservice operators implement the recommendations outlined in the two manuals. This target figure is used in calculating the burden in tables 1 and 2 of this document because the agency lacks data on how to base an estimate of how many retail and foodservice establishments are likely to use one or more of the manuals to voluntarily implement a comprehensive food safety management system based on HACCP principles or a risk control plan for out-of-control processes identified during an inspection. FDA's estimate of the total number of retail and foodservice establishments is based on numbers obtained from the two major trade organizations representing these industries, the Food Marketing Institute and the National Restaurant Association, respectively. FDA seeks comments on this estimate. The hour burden estimates in table 1 of this document for operators who follow the HACCP-based recommendations in the Operator's Manual are based on the estimated average annual information collection burden for mandatory HACCP rules, including seafood HACCP (60 FR 65096 at 65178, December 18, 1995) and juice HACCP (66 FR 6138 at 6202, January 19, 2001). FDA estimates that during the first year, 20 labor hours are needed to conduct the hazard analysis and 60 labor hours are needed to develop a food safety management system (HACCP plan). Once the system is in place, the annual frequency of records is based on 365 operating days per year. Assuming there is one recordkeeper per shift of operation, the agency estimates that two recordkeepers per day would be needed to conduct monitoring, corrective action, recordkeeping, and verification outlined in the system. The agency further estimates that validation will be conducted once per year, based on menu or food list changes, changes in distributors, or changes in food preparation processes used. The validation will require a total of 4 labor hours. The second set of estimates in table 1 of this document shows the annual burden for developing and implementing a risk control plan to control specific out-of-control foodborne illness risk factors identified during an inspection by a State, local, or tribal regulatory authority. If an operator decides to use a risk control plan as recommended in the Regulator's Manual, one person from the establishment is needed to work with the regulator to develop the written plan. FDA estimates that two recordkeepers per day (one recordkeeper for each shift) would be needed to conduct monitoring, corrective action, recordkeeping, and verification outlined in the risk control plan. The estimated duration of implementation for a risk control plan is 90 days, which is the minimum recommended time to achieve long-term behavior change. **Table 2.—Estimated Annual Recordkeeping Burden for Regulators** 1 Types of Records No. of Recordkeepers Annual Frequency of Recordkeeping Total Annual Records Hours per Recordkeeper Total Hours Voluntary Food Safety Management System Evaluation (includes validation, verification, and completion of verification inspection checklist) 50,000 1 50,000 16 800,000 Total Annual Burden for Regulators 800,000 1 There are no capital costs or operating and maintenance costs associated with this collection of information. It is difficult to predict the number of State, local, and tribal regulatory jurisdictions that will use the Regulator's Manual. But FDA anticipates that retail and foodservice establishments which voluntarily develop and implement a food safety management system based on the Operator's Manual will request their regulatory authorities to conduct an evaluation of their system. The estimates in table 2 of this document for the annual burden to State, local, and tribal regulators that follow the recommendations in the Regulator's Manual were calculated based on the usual time needed for one person to evaluate a voluntarily-implemented food safety management system and record the findings. The number of times an inspector may be asked by an operator to evaluate a voluntarily-implemented system is not expected to exceed once per year. Dated: December 8, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E5-7644 Filed 12-21-05; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Advisory Committees; Tentative Schedule of Meetings for 2006 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing a tentative schedule of forthcoming meetings of its public advisory committees for 2006. During 1991, at the request of the Commissioner of Food and Drugs (the Commissioner), the Institute of Medicine (the IOM) conducted a study of the use of FDA's advisory committees. In its final report, one of the IOM's recommendations was for the agency to publish an annual tentative schedule of its meetings in the **Federal Register** . This publication implements the IOM's recommendation. FOR FURTHER INFORMATION CONTACT: Theresa L. Green, Advisory Committee Oversight and Management Staff (HF-4), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1220. SUPPLEMENTARY INFORMATION: The IOM, at the request of the Commissioner, undertook a study of the use of the FDA's advisory committees. In its final report in 1992, one of the IOM's recommendations was for FDA to adopt a policy of publishing an advance yearly schedule of its upcoming public advisory committee meetings in the **Federal Register** ; FDA has implemented this recommendation. The annual publication of tentatively scheduled advisory committee meetings will provide both advisory committee members and the public with the opportunity, in advance, to schedule attendance at FDA's upcoming advisory committee meetings. Because the schedule is tentative, amendments to this notice will not be published in the **Federal Register** . However, changes to the schedule will be posted on the FDA advisory committees' Internet site located at *http://www.fda.gov/oc/advisory/default.htm* . FDA will continue to publish a **Federal Register** notice 15 days in advance of each upcoming advisory committee meeting, to announce the meeting (21 CFR 14.20). The following list announces FDA's tentatively schedule advisory committee meeting for 2006. You may also obtain up-to-date information by calling the Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). Committee Name Tentative Date(s) of Meetings Advisory Committee 10-Digit Information Line Code OFFICE OF THE COMMISSIONER Pediatric Advisory Committee March, June, and November day(s) to be announced. 8732310001 Science Board to the Food and Drug Administration April and November day(s) to be announced. 3014512603 CENTER FOR BIOLOGICS EVALUATION AND RESEARCH Allergenic Products Advisory Committee March 31, September 13. 3014512388 Blood Products Advisory Committee March 9-10, July 13-14, October 26-27. 3014519516 Cellular, Tissue and Gene Therapies Advisory Committee February 9-10, July 13-14, November 2-3. 3014512389 Transmissible Spongiform Encephalopathies Advisory Committee To be announced. 3014512392 Vaccines and Related Biological Products Advisory Committee February 17, May 17-18, September 20-21, November 15-16. 3014512391 CENTER FOR DRUG EVALUATION AND RESEARCH Anesthetic and Life Support Drugs Advisory Committee To be announced. 3014512529 Anti-Infective Drugs Advisory Committee To be announced. 3014512530 Antiviral Drugs Advisory Committee To be announced. 3014512531 Arthritis Advisory Committee To be announced. 3014512532 Cardiovascular and Renal Drugs Advisory Committee April 25-26, July 25-26, November 1-2. 3014512533 Dermatologic and Ophthalmic Drugs Advisory Committee To be announced. 3014512534 Drug Safety and Risk Management Advisory Committee February 9-10, May 4-5. 3014512535 Endocrinologic and Metabolic Drugs Advisory Committee January 23, May 3-4, August 23-24, November 8-9. 3014512536 Gastrointestinal Drugs Advisory Committee September and November day(s) to be announced. 3014512538 Nonprescription Drugs Advisory Committee January 23-24. 3014512541 Oncologic Drugs Advisory Committee March 14 (Pediatric Subcommittee), March 15, June 2, September 12-13, December 6-7. 3014512542 Peripheral and Central Nervous System Drugs Advisory Committee March 7-8. 3014512543 Pharmaceutical Science, Advisory Committee for April 13-14 (Clinical Pharmacology Subcommittee), October 18-19 (Clinical Pharmacology Subcommittee), April, May, and October day(s) to be announced. 3014512539 Psychopharmacologic Drugs Advisory Committee To be announced. 3014512544 Pulmonary-Allergy Drugs Advisory Committee January 24. 3014512545 Reproductive Health Drugs, Advisory Committee for May and June day(s) to be announced. 3014512537 CENTER FOR DEVICES AND RADIOLOGICAL HEALTH Device Good Manufacturing Practice Advisory Committee No tentative meeting scheduled. 3014512398 Medical Devices Advisory Committee (Comprised of 18 Panels) Anesthesiology and Respiratory Therapy Devices Panel April 7, October 6. 3014512624 Circulatory System Devices Panel February 16, April 21, June 16, August 18, October 20. 3014512625 Clinical Chemistry and Clinical Toxicology Devices Panel February 22-23, May 24-25, September 7-8, December 6-7. 3014512514 Dental Products Panel February 28, July 25, October 24. 3014512518 Ear, Nose, and Throat Devices Panel February 1-2, April 3-4, June 15-16, August 10-11, October 11-12, December 4-5. 3014512522 Gastroenterology-Urology Devices Panel March 3, May 5, July 21, October 20. 3014512523 General and Plastic Surgery Devices Panel April 27-28, August 24-25, December 4-5. 3014512519 General Hospital and Personal Use Devices Panel February 9-10, June 12-13, September 28-29. 3014512520 Hematology and Pathology Devices Panel April 28, October 20. 3014512515 Immunology Devices Panel July 14, November 8. 3014512516 Medical Devices Dispute Resolution Panel Meeting scheduled as needed. 3014510232 Microbiology Devices Panel February 23-24, September 21-22, October 26-27. 3014512517 Molecular and Clinical Genetics Panel April 13-14, October 5-6. 3014510231 Neurological Devices Panel March 2-4, August 3-4, June 5-6, August 28-29, November 13-14. 3014512513 Obstetrics-Gynecology Devices Panel March 27-28, June 5-6, August 28-29, November 13-14. 3014512524 Ophthalmic Devices Panel March 7-8, May 18, July 13-14, September 19-20, November 2-3. 3014512396 Orthopaedic and Rehabilitation Devices Panel February 2-3, July 27-28, October 26-27, December 11-12. 3014512521 Radiological Devices Panel February 7, May 23, September 12, November 7. 3014512526 National Mammography Quality Assurance Advisory Committee August 28. 3014512397 Technical Electronic Product Radiation Safety Standards Committee October 4. 3014512399 CENTER FOR FOOD SAFETY AND APPLIED NUTRITION Food Advisory Committee March 1, May 3, July 12, September 13. 3014510564 CENTER FOR VETERINARY MEDICINE Veterinary Medicine Advisory Committee March 15, October 16. 3014512548 NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH

(NCTR)Science Advisory Board to NCTR April day(s) to be announced. 3014512559 Advisory Committee on Special Studies Relating to the Possible Long-Term Health Effects of Phenoxy Herbicides and Contaminants (Ranch Hands) February day(s) to be announced. 3014512560 Dated: December 14, 2005. Jason Brodsky, Acting Associate Commissioner for External Relations. [FR Doc. E5-7645 Filed 12-21-05; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004P-0329] Hand-Held, Doppler Ultrasound Prenatal Listening Devices AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop; request for comments. The Food and Drug Administration

(FDA)is announcing a public workshop to discuss scientific information bearing on whether hand-held Doppler ultrasound prenatal listening devices should be made available for use over-the-counter (OTC). This 1-day workshop is intended to provide members of the academic, scientific, and clinical communities; industry; consumer, and patient advocacy groups; and others with a forum for presenting their perspectives about available scientific literature and clinical studies relating to hand-held Doppler ultrasound prenatal listening devices. Written comments submitted to the docket before the workshop and information gathered at the workshop will be used by FDA to further identify and evaluate the risks and benefits associated with possible OTC availability of hand-held prenatal Doppler ultrasound listening devices. *Date and Time:* The public workshop will be held on Wednesday, March 29, 2006, from 9 a.m. to 3:30 p.m. The deadline for registration is Friday, March 10, 2006. Requests to make presentations at the public workshop and written or electronic comments will be accepted until Friday, March 10, 2006. *Addresses:* The public workshop will be held at the Hilton Washington DC North, 620 Perry Pkwy., Gaithersburg, MD, 20877. Additional information about and directions to the facility are available on the Internet at *http://www.hilton.com/en/hi/hotels/index.jhtml?ctyhocn=GAIGHHF* . (FDA has verified the Web site address, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the **Federal Register** .) Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . *Contact:* Domini Cassis, Center for Devices and Radiological Health (HFZ-215), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, e-mail: *domini.cassis@fda.hhs.gov* , 240-276-2342. *Agenda* : At the workshop, FDA will hear presentations and oral comments from interested members of the public regarding Doppler ultrasound technology as used in hand-held prenatal listening devices. FDA anticipates that presenters may include representatives from the academic, scientific, and clinical communities; device, drug, and biological product manufacturers; consumer and patient advocacy groups; and others. *Registration and Requests for Presentations* : There is no fee to attend this public workshop; however, registration is required. The deadline for registration is Friday, March 10, 2006. Early registration is recommended, as seats are limited. Space will be filled in order of receipt of registration. There will be no on-site registration. Please submit registration information (including name, title, firm name, address, e-mail address, telephone number, and fax number) by March 10, 2006 (see *Contact* ). Interested persons who are unable to attend the workshop are encouraged to submit written comments (see *Request for Comments* ). Those who wish to make presentations during the public workshop should submit written notification including the following:

(1)The specific issue(s) you intend to address;

(2)the names and addresses of all individuals that will participate in your presentation;

(3)the approximate amount of time your presentation will require; and

(4)two copies of all presentation materials to Domini Cassis by March 10, 2006. Presentations will be limited to the topics outlined in the SUPPLEMENTARY INFORMATION section of this document and, depending on the number of speakers, FDA may limit the time allotted for each presentation. If you need special accommodations due to a disability, please contact Anne Marie Williams at 301-594-1283 at least 7 days in advance of the workshop. *Request for Comments:* Interested persons may submit to the Division of Dockets Management (see *Addresses* ) written or electronic comments regarding this document. Two paper copies of any mailed comments are to be submitted, except that individuals may submit one paper copy. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. *Transcripts:* Following the workshop, transcripts will be available for review at the Division of Dockets Management (see *Addresses* ). SUPPLEMENTARY INFORMATION: I. Background Since July 2002, FDA has received three citizen petitions requesting that it grant OTC status to hand-held prenatal listening devices that produce no more than 20 mW/cm2 of Doppler ultrasound intensity (FDA Docket Nos. 2002P-0338, 2003P-0438, and 2004P-0329.) Currently, these products are class II devices that are legally available only by prescription. FDA denied petitions 2002P-0338 and 2003P-0438, citing its concern over the safety of exposing a developing fetus to Doppler ultrasound without the order or instruction of a physician, and referencing the following studies: 1. “Sinistrality—A Side-Effect of Prenatal Sonography: A Comparative Study of Young Men.” Keiler, H., et al.; *Epidemiology* ; 12:618-623 (2001). 2. “Acceleration of Fresh Fracture Repair Using the Sonic Accelerated Fracture Healing System (SAFHS): A Review.” Warden, S.J., et al.; *Calcified Tissue International* ; 66:157-163 (2000). 3. “Acceleration of Tibial Fracture-Healing by Non-Invasive, Low Intensity Pulsed Ultrasound.” Heckman, J., et al.; *Journal of Bone and Joint Surgery* ; 76A:26-34 (1994). 4. “Accelerated Healing of Distal Radial Fractures With the Use of Specific, Low-Intensity Ultrasound. A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Study.” Kristiansen, T., et al.; *Journal of Bone and Joint Surgery* , 79A:961-973 (1997). 5. “Routine Ultrasound Screening in Pregnancy and the Children's Subsequent Handedness.” Kieler, H., et al.; *Early Human Development* ; 50:233-245 (1998). FDA reiterated its concerns in response to the most recent petition, 2004P-0329, but agreed to hold a public workshop in which relevant issues surrounding the proposal for OTC sales, distribution, and unsupervised use of these devices could be discussed. This public workshop is not intended to address legal or regulatory issues. Rather, FDA intends to collect information from outside experts and stakeholders that could help the agency better identify and evaluate the risks and benefits of uncontrolled exposure to Doppler ultrasound energy introduced through hand-held prenatal listening devices. II. References The above references have been placed on display in the Division of Dockets Management (see *Addresses* ) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. Dated: December 16, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E5-7643 Filed 12-21-05; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center for Complementary & Alternative Medicine; Notice of Meeting Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the National Advisory Council for Complementary and Alternative Medicine (NACCAM) meeting. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. *Name of Committee:* National Advisory Council for Complementary and Alternative Medicine. *Date:* December 29, 2005. *Open:* 12 p.m. to 1 p.m. *Agenda:* The agenda includes Opening Remarks by Director, NCCAM, and a Small Business Innovative Research

(SBIR)concept. *Place:* 6707 Democracy Boulevard, Two Democracy, Room 401, Bethesda, Maryland 20892. (Telephone Conference Call). *Contact Person:* Jane F. Kinsel, PhD., M.B.A., Executive Secretary, National Center for Complementary and Alternative Medicine, National Institutes of Health, 6707 Democracy Blvd., Suite 401, Bethesda, MD 20892.

(301)496-6701. The meeting is being published less than 15 days prior to the meeting due to scheduling conflicts. Copies of the meeting agenda and the roster of members will be furnished upon request by contacting Dr. Jane Kinsel, Executive Secretary, NACCAM, National Institutes of Health, 6707 Democracy Boulevard, Suite 401, Bethesda, Maryland 20892, 301-496-6701, Fax 301-480-9970, or via e-mail at *naccames@mail.nih.gov.* Dated: December 16, 2005. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy, NIH. [FR Doc. 05-24379 Filed 12-21-05; 8:45 am]

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