Notices. Notice

4,716 words·~21 min read·/register/2006/08/17/06-6966

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 4163-19-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel: State-Based Occupational Safety and Health Surveillance, Program Announcement With Special Receipt Date Program Announcement Number

(PAR)04-106 In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention

(CDC)announces the following meeting: *Name:* Disease, Disability, and Injury Prevention and Control. *Special Emphasis Panel:* State-Based Occupational Safety and Health Surveillance, Program Announcement with Special Receipt Date PAR 04-106. *Time and Date:* 12 p.m.-2 p.m., September 1, 2006 (Closed). *Place:* Teleconference, 2400 Century Parkway, NE., 4th Floor, Atlanta, GA 30345. *Status:* The meeting will be closed to the public in accordance with provisions set forth in section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92-463. *Matters to be Discussed:* The meeting will include the review, discussion, and evaluation of research grants in response to PAR 04-106, “State-Based Occupational Safety and Health Surveillance,” Program Announcement with Special Receipt Date. *Contact Person for More Information:* M. Chris Langub, Ph.D., Scientific Review Administrator, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, 1600 Clifton Road, Mailstop E-74, Atlanta, Georgia 30333, phone

(404)498-2543. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: August 10, 2006. Alvin Hall, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E6-13555 Filed 8-16-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0166] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; MedWatch—The Food and Drug Administration Safety Information and Adverse Event Reporting Program; Proposal to Survey MedWatch Partners Organizations AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a collection of information entitled “MedWatch—The Food and Drug Administration Safety Information and Adverse event Reporting Program; Proposal to Survey MedWatch Partners Organizations” has been approved by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Liz Berbakos, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1482. SUPPLEMENTARY INFORMATION: In the **Federal Register** of May 1, 2006 (71 FR 25591), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0593. The approval expires on December 31, 2006. A copy of the supporting statement for this information collection is available on the Internet at *http://www.fda.gov/ohrms/dockets* . Dated: August 10, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-13503 Filed 8-16-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N-0500] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Requirements for Collection of Data Relating to the Prevention of Medical Gas Mixups at Health Care Facilities—Survey AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a collection of information entitled "Requirements for Collection of Data Relating to the Prevention of Medical Gas Mixups at Health Care Facilities—Survey" has been approved by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Liz Berbakos, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1482. SUPPLEMENTARY INFORMATION: In the **Federal Register** of May 25, 2006 (71 FR 30146), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0548. The approval expires on August 31, 2008. A copy of the supporting statement for this information collection is available on the Internet at *http://www.fda.gov/ohrms/dockets* . Dated: August 10, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-13565 Filed 8-16-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Heparin Catheter Lock-Flush Solutions; Transfer of Primary Responsibility from Center for Drug Evaluation and Research to Center for Devices and Radiological Health AGENCY: Food and Drug Administration, HHS. ACTION: Notice; announcement of transfer. SUMMARY: The Food and Drug Administration

(FDA)is announcing the transfer of primary responsibility for the regulation of heparin catheter lock-flush solution products from the Center for Drug Evaluation and Research

(CDER)to the Center for Devices and Radiological Health (CDRH). These products are combination drug-device products. The transfer of lead review responsibility to CDRH is based on FDA's determination that the primary mode of action for these heparin catheter lock-flush solution products is that of the device part of the combination. The transfer provides consistency and efficiency in the regulation of these combination products by treating like products similarly. DATES: The effective date of the transfer is October 16, 2006. FOR FURTHER INFORMATION CONTACT: *For information regarding this notice* : James S. Cohen, Office of the Commissioner (HFG-3), Food and Drug Administration, 15800 Crabbs Branch Way, Rockville, MD 20855, 301-427-1934. *For questions on what to submit in the 510(k) submission* : Sheila A. Murphe, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., rm. 350AA, Rockville, MD 20850, 301-443-8913, ext. 203. SUPPLEMENTARY INFORMATION: Heparin catheter lock-flush solution products are intended to enhance the performance of intravascular catheters. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings that are inserted into a patient's vascular system for short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. Heparin catheter lock-flush solutions are periodically inserted into and stored within the catheter to keep the catheter patent and to prevent blood from clotting within the catheter between uses. Prior to the mid-1990's, heparin catheter lock-flush solution products were regulated under the new drug and abbreviated new drug provisions of the Federal Food, Drug, and Cosmetic Act (the act), with CDER serving as the lead agency review component. Many of the available marketed products were approved under abbreviated new drug applications (“generic drugs”). However, more recently, based on several jurisdictional determinations by FDA for specific products, applications for catheter lock-flush solutions containing anticoagulant, such as heparin, or antimicrobial components have been assigned to CDRH and regulated under the device provisions of the act. FDA is now transferring the applications for heparin catheter lock-flush solution products that are in CDER to reflect these more current jurisdictional determinations. Heparin catheter lock-flush solutions are intended to maintain patency when the catheter is not being used to sample blood, monitor blood pressure, or administer fluids to the patient. The solution component of the product (i.e., sterile saline or sterile water) acts by physically occupying space within the intravenous catheter and exerting pressure on the patient's circulating blood. This action helps to prevent the patient's blood from backfilling into the catheter, clotting, and contributing to microbial contamination. When acting in this way, the solution meets the definition of a device in the act in that it affects the structure or function of the body, and does not achieve its primary intended purposes through chemical or metabolic action (21 U.S.C. 321(h)). Likewise, the heparin (i.e. the anticoagulant) component of the product meets the definition of a drug in that it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man, and is intended to affect the structure or function of the body of man (21 U.S.C. 321(g)). Catheter lock-flush solutions that contain both drug and device components are combination products as defined in 21 CFR 3.2(e)(1). FDA is responsible for assigning combination products to a lead agency Center for regulation based upon the agency's determination of the combination product's “primary mode of action.” (See 21 U.S.C. 353(g)(1) and 21 CFR 3.4.) FDA has determined that the primary mode of action of heparin catheter lock-flush solution products in maintaining catheter patency is attributable to the device component's role in physically occupying space and applying pressure within the catheter. FDA likewise has determined that the drug component of the product (heparin) performs a secondary role by acting chemically to prevent thrombotic occlusions within the catheter. Accordingly, to enhance consistency and efficiency in the regulation of these combination products by treating like products similarly, FDA is transferring primary review responsibility from CDER to CDRH for heparin catheter lock-flush solution products that have been regulated under the drug provisions of the act. The transferred products will be reviewed and regulated under the device provisions of the act. As with all combination products, CDRH will consult with CDER regarding the drug components of these products as appropriate. Catheter lock-flush solutions that contain only water or saline are considered devices rather than combination products and are regulated under the device provisions of the act. The agency intends to assist manufacturers of currently marketed heparin catheter lock- flush solution products in the transition from approved new drug applications

(NDAs)or approved abbreviated new drug applications (ANDAs) to 510(k) submissions under the device provisions of the act. Based upon the submissions made and the prior review of these products under the drug provisions of the act, FDA has determined that heparin catheter lock-flush solution products approved under these particular approved NDAs or ANDAs are substantially equivalent to heparin catheter lock-flush solution products cleared for marketing under section 510(k) of the act (21 U.S.C. 360(k)) and the approved NDAs or ANDAs will be considered cleared device premarket notifications (510(k) clearances) under section 510(k) when FDA has provided the sponsor written notification of the transfer and its effective date. No application user fees will be assessed for this administrative transfer. NDA and ANDA manufacturers that have previously notified FDA (i.e. before the date of this notice) that they have discontinued marketing their heparin catheter lock-flush solution products will be subject to review and clearance of a 510(k) submission prior to marketing their product again. Heparin catheter lock-flush solution products are accessories to, and regulated along with, intravascular catheters as Class II devices (special controls). (See 21 CFR 880.5200.) Upon the effective date of the transfer, the transferred products will be subject to the provisions of section 510(k) of the act and its implementing regulations (part 807 (21 CFR part 807)). The transferred products will be subject to the general control provisions of section 513 of the act, including the Registration and Listing regulation (part 807), the Quality System Regulation (part 820 (21 CFR part 820)), and the Medical Device Reporting regulation (21 CFR part 803). Manufacturers planning to change or modify the design, components, method of manufacture, or intended use of a transferred heparin catheter lock-flush solution product should evaluate whether a 510(k) submission is required for the change or modification as set forth in § 807.81(a)(3). If a 510(k) submission is required, the manufacturer should cite in its initial submission the NDA or ANDA number held for the product and include a copy of the letter sent from FDA notifying the sponsor of the transfer of review responsibility to CDRH. FDA finds that there is a substantial likelihood that failure to comply with the Quality System Regulation (part 820) for this product will potentially present a serious risk to human health. Therefore, future 510(k) submissions for heparin catheter lock-flush solution products will be subject to pre-clearance inspections in accordance with section 513(f)(5) of the act (21 U.S.C. 360c). FDA will contact applicants holding approved NDAs or ANDAs that it believes have products affected by this transfer. Holders of applications subject to transfer, holders of applications for discontinued heparin catheter lock-flush solutions products, or holders of applications for catheter lock-flush solution products with other ingredients who are uncertain as to which agency Center has primary jurisdiction, should contact James S. Cohen (see the FOR FURTHER INFORMATION CONTACT section). Dated: August 9, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-13509 Filed 8-16-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0312] Preparation for International Conference on Harmonization Meetings in Chicago, Illinois; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of meeting. SUMMARY: The Food and Drug Administration

(FDA)is announcing a public meeting entitled “Preparation for ICH meetings in Chicago, Illinois” to provide information and receive comments on the International Conference on Harmonization

(ICH)as well as the upcoming meetings in Chicago, IL. The topics to be discussed are the topics for discussion at the forthcoming ICH Steering Committee Meeting. The purpose of the meeting is to solicit public input prior to the next Steering Committee and Expert Working Groups meetings in Chicago, IL, October 23 through 26, 2006, at which discussion of the topics underway and the future of ICH will continue. *Date and Time* : The meeting will be held on Monday, October 2, 2006, from 1:30 p.m. to 4 p.m. *Location* : The meeting will be held at 5600 Fishers Lane, 3d Fl., Conference Room G, Rockville, MD 20857. For security reasons, all attendees are asked to arrive no later than 1:25 p.m., as you will be escorted from the front entrance of 5600 Fishers Lane to Conference Room G. *Contact Person* : Tammie Bell, Office of the Commissioner (HFG-1), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0919, e-mail: *Tammie.Bell2@fda.hhs.gov* , FAX: 301-480-0716. *Registration and Requests for Oral Presentations* : Send registration information (including name, title, firm name, address, telephone, and fax number), written material and requests to make oral presentations, to the contact person by September 25, 2006. If you need special accommodations due to a disability, please contact Tammie Bell at least 7 days in advance. SUPPLEMENTARY INFORMATION: The ICH was established in 1990 as a joint regulatory/industry project to improve, through harmonization, the efficiency of the process for developing and registering new medicinal products in Europe, Japan, and the United States without compromising the regulatory obligations of safety and effectiveness. In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for medical product development among regulatory agencies. ICH was organized to provide an opportunity for harmonization initiatives to be developed with input from both regulatory and industry representatives. ICH is concerned with harmonization among three regions: The European Union, Japan, and the United States. The six ICH sponsors are the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labor and Welfare; the Japanese Pharmaceutical Manufacturers Association; the Centers for Drug Evaluation and Research and Biologics Evaluation and Research, FDA; and the Pharmaceutical Research and Manufacturers of America. The ICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation of Pharmaceutical Manufacturers Associations. The ICH Steering Committee includes representatives from each of the ICH sponsors and Health Canada, the European Free Trade Area and the World Health Organization. The ICH process has achieved significant harmonization of the technical requirements for the approval of pharmaceuticals for human use in the three ICH regions. The current ICH process and structure can be found at the following Web site: *http://www.ich.org* . Interested persons may present data, information, or views orally or in writing, on issues pending at the public meeting. Oral presentations from the public will be scheduled between approximately 3 p.m. and 4 p.m. Time allotted for oral presentations may be limited to 10 minutes. Those desiring to make oral presentations should notify the contact person by September 25, 2006, and submit a brief statement of the general nature of the evidence or arguments they which to present, the names and addresses, phone number, fax, and e-mail of proposed participants, and an indication of the approximate time requested to make their presentation. The agenda for the public meeting will be made available on September 18, 2006, via the Internet at *http://www.fda.gov/cder/meeting/ICH_20061002.htm* . *Transcripts* : Transcripts of the meeting may be requested in writing from the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857, approximately 15 working days after the meeting at a cost of 10 cents per page. Dated: August 10, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-13505 Filed 8-16-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Advisory Committee for Pharmaceutical Science; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. *Name of Committee* : Advisory Committee for Pharmaceutical Science. *General Function of the Committee* : To provide advice and recommendations to the agency on FDA's regulatory issues. *Date and Time* : The meeting will be held on October 5 and 6, 2006, from 8:30 a.m. to 5 p.m. *Location* : Food and Drug Administration, Center for Drug Evaluation and Research Advisory Committee Conference Room, rm. 1066, 5630 Fishers Lane, Rockville, MD. *Contact Person* : Mimi Phan, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301-827-7001, FAX: 301-827-6801, e-mail: *mimi.phan@fda.hhs.gov,* or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572) in the Washington, DC area), code 3014512539. Please call the Information Line for up-to-date information on this meeting. The background material will become available no later than the day before the meeting and will be posted on FDA's Web site at *http://www.fda.gov/ohrms/dockets/ac/acmenu.htm* under the heading “Advisory Committee for Pharmaceutical Science.” (Click on the year 2006 and scroll down to the above named committee meeting.) *Agenda* : On October 5, 2006, the committee will:

(1)Receive an update on the International Conference on Harmonization Quality Topics (Q8, Q9, Q10, Q4B, QOS) and discuss the impact on current regulatory direction, and

(2)receive and discuss a series of presentations from the different offices within the Office of Pharmaceutical Science on progress being made on quality-by-design

(QBD)initiatives, followed by presentations from the pharmaceutical industry trade associations (The Generic Pharmaceutical Association [GPhA] and The Pharmaceutical Research and Manufacturers of America [PhRMA]) on their QBD perspectives and issues. On October 6, 2006, the committee will:

(1)Receive an awareness presentation on risk management for complex pharmaceuticals,

(2)receive presentations and discuss bioequivalence issues pertaining to highly variable drugs,

(3)discuss current thinking on issues and definitions pertaining to nanotechnology,

(4)discuss implementation of definitions for topical dosage forms, and

(5)receive an update and discuss current strategies and direction for the Critical Path Initiative. *Procedure* : Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before September 21, 2006. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. each day. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before September 21, 2006. Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Mimi Phan at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). August 8, 2006. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E6-13506 Filed 8-16-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Psychopharmacologic Drugs Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration

(FDA)is announcing an amendment to the notice of the meeting of the Psychopharmacologic Drugs Advisory Committee. The meeting was announced in the **Federal Register** of July 20, 2006 (71 FR 41220). The amendment is being made to reflect a change in the *Date and Time* and *Agenda* portion of the notice. The *Agenda* scheduled for September 7, 2006, has been cancelled. The *Agenda* portion scheduled for September 8, 2006, has been moved to September 7, 2006. There are no other changes. FOR FURTHER INFORMATION CONTACT: Cicely Reese, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, rm. 1093), Rockville, MD 20857, 301-827-7001, FAX: 301-827-6776, e-mail: *cicely.reese@fda.hhs.gov* , or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512544. SUPPLEMENTARY INFORMATION: In the **Federal Register** of July 20, 2006, FDA announced that a meeting of the Psychopharmacologic Drugs Advisory Committee would be held on September 7, 2006, to discuss new drug application

(NDA)21-999, paliperidone extended-release

(ER)tablets, Janssen, L.P./Johnson & Johnson Pharmaceutical Research and Development, L.L.C., proposed indication for treatment of schizophrenia and on September 8, 2006, to discuss NDA 21-992, desvenlafaxine succinate (DVS 233), ER tablets, Wyeth Pharmaceuticals, proposed indication for treatment of major depressive disorder. On page 41220, in the first column, the Date and Time portion of the meeting is amended to read as follows: *Date and Time* : The meeting will be held on September 7, 2006, from 8 a.m. to 5 p.m. On page 41220, second column, the *Agenda* portion of the meeting is amended to read as follows: *Agenda* : On September 7, 2006, the committee will discuss new drug application

(NDA)21-992, desvenlafaxine succinate (DVS 233), extended-release tablets, Wyeth Pharmaceuticals, proposed indication for treatment of major depressive disorder (MDD). This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees. Dated: August 8, 2006. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E6-13502 Filed 8-16-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006D-0301] Draft Guidance for Industry; Animal Drug User Fees: Fees Exceed Costs Waivers and Reductions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of the draft guidance for industry (#183) entitled “Animal Drug User Fees: Fees Exceed Costs Waivers and Reductions.” The draft guidance explains the procedures FDA expects to use to evaluate waiver requests under the fees exceed costs waiver provision of the Animal Drug User Fee Act of 2003. DATES: Submit written or electronic comments on the draft guidance by October 31, 2006 to ensure their adequate consideration in preparation of the final document. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the draft guidance document to the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the draft guidance document 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.fda.gov/dockets/ecomments* . See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Dave Newkirk, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail: *david.newkirk@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: I. Background The Animal Drug User Fee Act of 2003 (ADUFA) (Public Law 108-130) amended the Federal Food, Drug, and Cosmetic Act (the act) and requires that FDA assess and collect user fees for certain applications, products, establishments, and sponsors. It also requires the agency to grant a waiver from, or a reduction of, those fees in certain circumstances. The draft guidance explains the procedures FDA expects to use to evaluate waiver requests under the fees exceed costs waiver provision of ADUFA. These procedures may be modified in the future as FDA gains more experience with waiver requests. To qualify for waiver consideration for fees due on or after October 1, 2004, a written request for a fees exceed costs waiver or reduction must be submitted no later than 180 days after the fee is due (section 740(i) of the act (21 U.S.C. 379j-12(i))). II. Significance of Guidance This level 1 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 topic. The document does not create or confer any rights for or on any person and will not operate to bind FDA or the public. Alternative approaches may be used as long as they satisfy the requirements of the applicable statutes and regulations. III. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in Guidance for Industry #170. These collections of information are subject to review by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) and have been approved under OMB Control No. 0910-0540. IV. Comments This draft guidance document is being distributed for comment purposes only and is not intended for implementation at this time. 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 full title of the draft guidance document and the docket number found in brackets in the heading of this document. A copy of the draft guidance and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. V. Electronic Access Electronic comments may be submitted on the Internet at *http://www.fda.gov/dockets/ecomments* . Once on the Internet site, select Docket No. 2006D-0301, “Animal Drug User Fees; Fees Exceeds Costs Waivers and Reductions” and follow the directions. A copy of this document may be obtained on the Internet from the CVM home page at *http://www.fda.gov/cvm* . Dated: August 10, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-13507 Filed 8-16-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Notice of Establishment Pursuant to the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), the Director, National Institutes of Health (NIH), announces the establishment of the NIH Office of Portfolio Analysis and Strategic Initiatives (OPASI) Council of Councils (Council). The Council will consult with, and provide advice and recommendations to the Director NIH, the Director, OPASI, and the individual Institute and Center

(IC)Directors on potential trans-NIH initiatives at the conceptual stage. The Council's advice and recommendations will assist the IC Directors in identifying trans-NIH initiatives to be pursued for further development. Duration of this committee is two years from the date the Charter is filed. Dated: August 8, 2006. Elias Zerhouni, Director, National Institutes of Health. [FR Doc. 06-6966 Filed 8-16-06; 8:45 am]

Connectionstraces to 10

Traces to 10 documents

U.S. Code