Notices. Request for nominations of scientific experts

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BILLING CODE 4150-24-M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Toxicology Program (NTP); Report on Carcinogens; Request for Nominations of Scientific Experts for Review of Candidate Substances for the 12th Report on Carcinogens AGENCY: National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH). ACTION: Request for nominations of scientific experts. SUMMARY: On April 16, 2007, NTP released the final review process for preparation of the 12th Report on Carcinogens (RoC, 72FR18999, available at *http://ntp.niehs.nih.gov/go/9732* ).

This notice invites the public to nominate scientists to serve on expert panels. These scientists should have expertise and/or knowledge relevant to evaluation of the potential carcinogenic hazard of the candidate substances that will undergo review for the 12th RoC. DATES: Nominations of scientific experts received by June 8, 2007. ADDRESSES: Nominations should be sent to Dr. C. W. Jameson, Report on Carcinogens (NIEHS, P.O Box 12233, MD EC-17, Research Triangle Park, NC 27709; *fax:*

(919)541-0144, e-mail: *jameson@niehs.nih.gov* . Courier address: Report on Carcinogens, NIEHS, 79 Alexander Drive, Building 4401, Room 3118, Research Triangle Park, NC 27709). FOR FURTHER INFORMATION CONTACT: Dr. C. W. Jameson, telephone:

(919)541-4096 or *jameson@niehs.nih.gov* . SUPPLEMENTARY INFORMATION: Request for Nominations of Scientific Experts The review process for preparation of the 12th RoC is available on the NTP RoC Web site ( *http://ntp.niehs.nih.gov/go/15208* ). The process includes development of a draft background document for each candidate substance undergoing review for the 12th RoC. The NTP will convene an *ad hoc* expert panel to peer review the draft background document at a public meeting and make a recommendation to the NTP on the candidate substance's listing status for the RoC. The NTP invites the public to nominate scientists to serve on the expert panels who have expertise and/or knowledge relevant to the evaluation of carcinogenicity for the candidate substances (listed below). Relevant areas of expertise and/or knowledge include, for example, biostatistics, carcinogenesis, chemistry, epidemiology, exposure assessment, molecular biology, pathology, toxicokinetics, and toxicology. Scientists nominated in response to a previous notice (70FR60548), which sought names of scientists to write and/or review background documents, will also be considered as potential candidates for the expert panels. Each nomination should include contact information for the nominee [name, affiliation (if any), address, telephone, fax, and e-mail], the candidate substance(s) for which they have relevant expertise and/or knowledge, and a complete curriculum vitae. Final selection of individuals to serve on these panels will be made in accordance with the Federal Advisory Committee Act and Department of Health and Human Services implementing regulations. Previously, NTP sought input on substances nominated for possible review for the 12th RoC (69FR28940, 69FR62276, and 70FR60548). The 14 candidate substances selected for review for the 12th RoC are listed below. Information on these candidate substances is available on the NTP Web site for the 12th RoC ( *http://ntp.niehs.nih.gov/go/10091* ) or by contacting Dr. C. W. Jameson (see “ FOR FURTHER INFORMATION CONTACT ” above). The candidate substances for the 12th RoC are: • Aristolochic acid-related exposures:

(1)Botanical products containing aristolochic acid

(2)Aristolochic acid • Captafol • Cobalt-tungsten carbide powders and hard metals • Di (2-ethylhexyl) phthalate • Selected DNA topoisomerase II inhibitors:

(1)Etoposide

(2)Etoposide in combination with cisplatin and bleomycin

(3)Teniposide • Formaldehyde • Glass wool fibers (certain) • Metalworking fluids • *ortho* -Nitrotoluene • Riddelliine • Styrene Background Information on the Report on Carcinogens The RoC is a congressionally mandated document [Section 301(b)(4) of the Public Health Services Act, 42 U.S.C. 241(b)(4)], approved by the Secretary of Health and Human Services (HHS), that identifies agents, substances, mixtures, or exposure circumstances (collectively referred to as “substances”) that may pose a carcinogenic hazard to human health. The Secretary, HHS, delegated responsibility for preparing the report to the NTP. Substances are listed in the RoC as either *known to be human carcinogens or reasonably anticipated to be human carcinogens* . Publication of the RoC is the end result of an extensive scientific review and assessment process with multiple opportunities for public comment The NTP solicits and encourages the broadest participation from interested individuals or parties in nominating agents, substances, mixtures, or exposure circumstances for review for future RoCs. Nominations should contain a rationale for review. Appropriate background information and relevant data [ *e.g.* , journal articles, NTP Technical Reports, International Agency for Research on Cancer

(IARC)listings, exposure surveys, release inventories, *etc* .] that support a nomination should be provided or referenced when possible. Contact information for the nominator should also be included [name, affiliation (if any), address, telephone, fax, and e-mail]. Dated: April 30, 2007. Samuel H. Wilson, Deputy Director, National Institute of Environmental Health Sciences and National Toxicology Program. [FR Doc. E7-8899 Filed 5-8-07; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Toxicology Program (NTP), NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Peer Review Panel Report on Five In Vitro Pyrogen Test Methods: Availability and Request for Public Comments AGENCY: National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH). ACTION: Request for comments. SUMMARY: NICEATM in collaboration with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) convened an independent scientific peer review panel meeting on February 6, 2007, to evaluate the validation status of five in vitro pyrogen test methods proposed as replacements for the Rabbit Pyrogen Test (RPT). The peer review panel (“the Panel”) report from this meeting is now available. The report contains

(1)the Panel's evaluation of the validation status of the methods and

(2)the Panel's comments and conclusions on draft ICCVAM test method recommendations. NICEATM invites public comment on the Panel's report. The report is available on the NICEATM/ICCVAM Web site at ( *http://iccvam.niehs.nih.gov/methods/pyrogen/pyrogen.htm* ) or by contacting NICEATM (see FOR FURTHER INFORMATION CONTACT below). DATES: Written comments on the Panel report should be received by June 25, 2007. ADDRESSES: Comments should preferably be submitted electronically via the NICEATM/ICCVAM Web site: *http://iccvam.niehs.nih.gov/contact/FR_pubcomment.htm* . Comments can also be submitted by e-mail to *niceatm@niehs.nih.gov.* Written comments can be sent by mail or fax to Dr. William S. Stokes, NICEATM Director, NIH/NIEHS, P.O. Box 12233, MD EC-17, Research Triangle Park, NC 27709,

(fax)919-541-0947, (e-mail) *niceatm@niehs.nih.gov.* Courier address: NICEATM, 79 T.W. Alexander Drive, Building 4401, Room 3128, Research Triangle Park, NC 27709. FOR FURTHER INFORMATION CONTACT: Other correspondence should be directed to Dr. William S. Stokes, NICEATM Director (919-541-2384 or *niceatm@niehs.nih.gov* ). SUPPLEMENTARY INFORMATION Background The European Centre for the Validation of Alternative Methods (ECVAM) submitted five *in vitro* pyrogen test methods to ICCVAM for evaluation in 2006. The proposed test methods include: 1. The Human Whole Blood (WB)/IL-1 *In Vitro* Pyrogen Test: Application of Cryopreserved Human WB 2. The Monocytoid Cell Line Mono Mac 6 (MM6)/IL-6 *In Vitro* Pyrogen Test 3. The Human PBMC/IL-6 *In Vitro* Pyrogen Test 4. The Human WB/IL-1 *In Vitro* Pyrogen Test 5. The Human WB/IL-6 *In Vitro* Pyrogen Test These test methods are based on the measurement of proinflammatory cytokines released from either fresh or cryopreserved human blood cells or a human monocytoid line in response to the presence of Gram-negative endotoxin in parenteral pharmaceuticals. NICEATM and ICCVAM prepared a comprehensive background review document

(BRD)that included the available data for the five test methods and a separate document containing ICCVAM test method recommendations. At the peer review meeting, the Panel reviewed the BRD and evaluated the extent to which the ICCVAM criteria for validation and acceptance had been adequately addressed for the intended purpose of these test methods. The Panel also provided comments on the ICCVAM draft test method recommendations regarding the proposed usefulness and limitations, standardized protocols, performance standards, and future studies. The Panel's conclusions and recommendations on the five in vitro pyrogen test methods are described in the *Peer Review Panel Final Report: Five In Vitro Pyrogen Test Methods* (available at: *http://iccvam.niehs.nih.gov/methods/pyrogen/pyrogen.htm* ). The draft BRD and the draft test method recommendations are available at *http://iccvam.niehs.nih.gov/methods/pyrogen/pyrogen.htm.* Request for Comments NICEATM invites the submission of written comments on the Panel's report. When submitting written comments please refer to this **Federal Register** notice and include appropriate contact information (name, affiliation, mailing address, phone, fax, email, and sponsoring organization, if applicable). All comments received by the deadline listed above will be placed on the NICEATM/ICCVAM Web site ( *http://ntp-apps.niehs.nih.gov/iccvampb/searchPubCom.cfm* ) and made available to ICCVAM. In addition, there will be an opportunity for oral public comments on the Panel's report during a meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) scheduled for June 12, 2007. Information concerning the SACATM meeting will be published in a separate **Federal Register** notice and available on the SACATM website: ( *http://ntp.niehs.nih.gov/go/7441* ). Any written comments on the Panel report received prior to June 7, 2007, will be distributed to SACATM. ICCVAM will consider the Panel report along with the SACATM and public comments as it finalizes recommendations for the five *in vitro* pyrogen test methods. An ICCVAM test method evaluation report, which includes the ICCVAM final recommendations, will be forwarded to appropriate federal agencies for their consideration. This report will also be available to the public on the NICEATM/ICCVAM Web site and by request from NICEATM. Background Information on ICCVAM, NICEATM, and SACATM ICCVAM is an interagency committee composed of representatives from 15 federal regulatory and research agencies that use, generate, or disseminate toxicological information. ICCVAM conducts technical evaluations of new, revised, and alternative methods with regulatory applicability and promotes scientific validation and regulatory acceptance of toxicological test methods that more accurately assess safety and hazards of chemicals and products and that refine, reduce, and replace animal use. The ICCVAM Authorization Act of 2000 (42 U.S.C. 285l-3, available at *http://iccvam.niehs.nih.gov/docs/about_docs/PL106545.pdf* ) establishes ICCVAM as a permanent interagency committee of the NIEHS under NICEATM. NICEATM administers ICCVAM and provides scientific and operational support for ICCVAM-related activities. NICEATM and ICCVAM work collaboratively to evaluate new and improved test methods applicable to the needs of Federal agencies. Additional information about ICCVAM and NICEATM can be found at the ICCVAM/NICEATM Web site ( *http://iccvam.niehs.nih.gov* ). Additional information about SACATM, including the charter, roster, and records of past meetings, can be found at *http://ntp.niehs.nih.gov/go/167* . Dated: April 30, 2007. Samuel H. Wilson, Deputy Director, National Institute of Environmental Health Sciences and National Toxicology Program. [FR Doc. E7-8896 Filed 5-8-07; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Toxicology Program (NTP), NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Request for Data on the Use of Topical Anesthetics and Systemic Analgesics for In Vivo Eye Irritation Testing AGENCY: National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH). ACTION: Request for data on the use of topical anesthetics and systemic analgesics for in vivo ocular irritation testing. SUMMARY: The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and NICEATM request the submission of data and information on the use of topical anesthetics and systemic analgesics for alleviating pain and distress in rabbits during eye irritation testing. They also request the submission of information about other procedures and strategies that may reduce or eliminate pain and distress associated with *in vivo* eye irritation methods. DATES: Data should be received by June 25, 2007. ADDRESSES: Data should be sent by mail, fax, or e-mail to Dr. William S. Stokes, Director, NICEATM, NIEHS, P.O. Box 12233, MD EC-17, Research Triangle Park, NC, 27709,

(fax)919-541-0947, (e-mail) *niceatm@niehs.nih.gov. Courier address:* NICEATM, 79 T.W. Alexander Drive, Building 4401, Room 3128, Research Triangle Park, NC 27709. FOR FURTHER INFORMATION CONTACT: Dr. William S. Stokes, NICEATM Director, (phone) 919-541-2384 or *niceatm@niehs.nih.gov.* SUPPLEMENTARY INFORMATION Background The U.S. Environmental Protection Agency

(EPA)nominated to ICCVAM several activities relevant to reducing, replacing, or refining the use of rabbits in the current *in vivo* eye irritation test method ( **Federal Register** Vol. 69, No. 57, pages 13859-13861, March 24, 2004). One activity is to review ways to alleviate pain and suffering that might arise from current *in vivo* eye irritation testing. ICCVAM endorsed this activity with a high priority and recommended that NICEATM review the data currently available on the use of topical anesthetics and/or systemic analgesics to reduce animal pain and distress. As part of this review, NICEATM requests the submission of data from completed studies on the use of topical anesthetics and/or systemic analgesics for *in vivo* ocular irritancy testing. These data will be used to evaluate the validation status of the use of topical anesthetics and/or analgesics to reduce pain and distress for *in vivo* testing situations. ICCVAM and NICEATM also request the submission of information and data from *in vivo* methods, procedures, and/or strategies that may reduce or eliminate the pain and suffering associated with current *in vivo* eye irritation methods. Background Information on ICCVAM and NICEATM ICCVAM is an interagency committee composed of representatives from 15 federal regulatory and research agencies that use or generate toxicological information. ICCVAM conducts technical evaluations of new, revised, and alternative methods with regulatory applicability and promotes the scientific validation and regulatory acceptance of toxicological test methods that more accurately assess the safety and hazards of chemicals and products and that refine, reduce, or replace animal use. The ICCVAM Authorization Act of 2000 (42 U.S.C. 285 *l* -3) established ICCVAM as a permanent interagency committee of the NIEHS under NICEATM. NICEATM administers the ICCVAM and provides scientific and operational support for ICCVAM-related activities. Additional information about NICEATM and ICCVAM can be found at the following Web site: *http://iccvam.niehs.nih.gov.* Dated: April 30, 2007. Samuel H. Wilson, Deputy Director, National Institute of Environmental Health Sciences and National Toxicology Program. [FR Doc. E7-8898 Filed 5-8-07; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration on Aging Purpose of Notice: Availability of Funding Opportunity Announcement *Funding Opportunity Title/Program Name:* Aging and Disability Resource Center Initiative: Integrating Access to Long-Term Care. *Announcement Type:* Initial. *Funding Opportunity Number:* HHS-2007-AoA-DR-0707. *Statutory Authority:* The Older Americans Act of 2006, Public Law 109-365. *Catalog of Federal Domestic Assistance

(CFDA)Number:* 93.048, Title IV and Title II, Discretionary Projects. *Dates:* The deadline date for the submission of applications is June 29, 2007. I. Funding Opportunity Description In FY 2003, the Administration on Aging

(AoA)and the Centers for Medicare & Medicaid Services

(CMS)formed a historic partnership to launch the Aging and Disability Resource Center

(ADRC)demonstration grant initiative. The goal of the ADRC program is to empower individuals to make informed choices and to streamline access to long term support services. AoA and CMS share a vision to have Resource Centers in every community serving as highly visible and trusted places where people of all ages can turn for information on the full range of long term support options and a single point of entry to public long term support programs and benefits. ADRCs are a resource for both public and private-pay individuals. They serve older adults, younger individuals with disabilities, family caregivers, as well as persons planning for future long term support needs. ADRCs are also a resource for health and long term support professionals and others who provide services to older adults and to people with disabilities. Since FY 2003, 43 states have received three year grants from AoA and CMS to design and implement ADRC demonstrations serving the elderly and at least one other target population of adults with disabilities in at least one community. An ADRC Program Announcement published in FY 2003 resulted in the funding of twelve states that year with an additional twelve states funded to develop ADRC programs in FY 2004. Nineteen additional states were funded to develop ADRC programs based on a Program Announcement published in FY 2005. To view the Program Announcements published in FY 2003 and FY 2005 please visit *www.aoa.gov/prof/aging_dis/background.asp.* For more information on the 43 funded ADRC projects please visit *www.adrc-tae.org.* This announcement seeks proposals for competitive grants to assist states funded to develop ADRCs in FY 2004 to significantly expand their existing Resource Center programs. Building on current efforts, state Resource Center programs funded under this Program Announcement will be:

(1)Expanded to provide services to additional communities, and/or

(2)Positioned to assume the role as the only entry point to publicly funded long-term support systems, and/or;

(3)Enhanced to support states long-term care rebalancing efforts either through nursing facility diversion activities, nursing facility transition or participation in the re-direction of services dollars to consumer directed models including cash & counseling. A detailed description of the funding opportunity may be found at *http://www.aoa.gov/doingbus/fundopp/fundopp.asp.* II. Award Information 1. Funding Instrument Type These new grants will be issued as cooperative agreements because AoA, in cooperation with CMS, anticipates having substantial involvement with the recipients during performance of funded activities. This involvement may include collaboration, participation, or intervention in the funded activities. AoA, in cooperation with CMS, will also be involved in the development and implementation of the funded projects by way of conducting a review of the applications and providing technical assistance, training, guidance, and oversight throughout the one-year project period. Grantees will be expected to keep in contact with their Federal project officer on a regular basis. Grantees will also be expected to share all significant products that result from their projects with AoA. 2. Anticipated Total Priority Area Funding Per Budget Period The total amount of Federal funds available for this funding opportunity is $2.4 million. AoA anticipates funding up to 12 projects nationwide for a period of 1 year. The maximum Federal award for the entire project period is approximately $200,000. III. Eligibility Criteria And Other Requirements 1. Eligible Applicants Only states that received an AoA and CMS Aging and Disability Resource Center Grant in FY 2004 are eligible to apply. These states are Alaska, Arkansas, California, Florida, Georgia, Illinois, Indiana, Iowa, New Mexico, North Carolina, Northern Mariana Islands, and Wisconsin. Only the state agency that was the ADRC applicant in FY 2004, or a state agency with a Memorandum of Agreement with the existing ADRC grantee (e.g. the Single State Agency on Aging, Single State Medicaid Agency or State Agency serving the target populations of people with disabilities) may apply for this Resource Center grant. The applicant agency must have the documented support, in the form of a Memorandum of Understanding and active participation by the Single State Agency on Aging, the Single State Medicaid Agency and the State Agency(s) serving the target population(s) of people with disabilities specified in the applicant's proposal. A letter of support from the Governor indicating high-level state executive support and designating the lead agency is also required. Only one application per state will be accepted. “State” refers to the definition provided under 45 CFR 74.2. Executive Order 12372 is not applicable to these grant applications. 2. Cost Sharing or Matching Grantees are required to make a non-financial or cash recipient contribution (match) of a minimum of five percent (5%) of the total project cost. 3. DUNS Number All grant applicants must obtain a D-U-N-S number from Dun and Bradstreet. It is a nine-digit identification number, which provides unique identifiers of single business entities. The D-U-N-S number is free and easy to obtain from *http://www.dnb.com/US/duns_update/.* 4. Intergovernmental Review Executive Order 12372, Intergovernmental Review of Federal Programs, is not applicable to these grant applications. IV. Application and Submission Information 1. Address To Request Application Application kits are available by writing to the U.S. Department of Health and Human Services, Administration on Aging, Center for Planning and Policy, Washington, DC 20201, by calling Joseph Lugo at 202/357-3417, or online at *http://www.grants.gov.* 2. Address for Application Submission Applications must be submitted electronically to *www.grants.gov.* In order to be able to submit the application, you must register in the Central Contractor Registry

(CCR)database. Information about CCR is available at *www.grants.gov/CCRRegister.* Instructions for electronic submission of grant applications are available at *www.grants.gov.* 3. Submission Dates and Times To receive consideration, applications must be submitted electronically by midnight Eastern time by the deadline listed in the DATES section at the beginning of this Notice. V. Responsiveness Criteria Each application submitted will be screened to determine whether it was received by the closing date and time. Applications received by the closing date and time will be screened for completeness and conformity with the requirements outlined in Sections III and IV of this Notice and the Program Announcement. Only complete applications that meet these requirements will be reviewed and evaluated competitively. VI. Application Review Information Eligible applications in response to this announcement will be reviewed according to the following evaluation criteria: • Accomplishments and Problem Statement—Weight: 30 points. • Approach, Work Plan and Activities—Weight: 40 points. • Project Outcomes and Evaluation—Weight: 15 points. • Level of Effort (Organization and Management; Budget and Resources)—Weight: 15 points. VII. Agency Contacts Direct inquiries regarding programmatic issues can be directed to the U.S. Department of Health and Human Services, Administration on Aging, Center for Planning and Policy Development, Washington, DC 20201, Joseph Lugo at telephone

(202)357-3417. Dated: May 4, 2007. Josefina G. Carbonell, Assistant Secretary for Aging. [FR Doc. E7-8880 Filed 5-8-07; 8:45 am] BILLING CODE 4154-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007D-0137] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Gene Expression Profiling Test System for Breast Cancer Prognosis; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of the guidance entitled “Class II Special Controls Guidance Document: Gene Expression Profiling Test System for Breast Cancer Prognosis.” This guidance document describes a means by which gene expression profiling test systems for breast cancer prognosis may comply with the requirement of special controls for class II devices. It includes recommendations for validation of performance characteristics and recommendations for product labeling. Elsewhere in this issue of the **Federal Register** , FDA is publishing a final rule to classify gene expression profiling test systems for breast cancer prognosis into class II (special controls). This guidance document is immediately in effect as the special control for gene expression profiling test systems for breast cancer prognosis, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs). DATES: Submit written or electronic comments on this guidance at any time. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the guidance document entitled “Class II Special Controls Guidance Document: Gene Expression Profiling Test System for Breast Cancer Prognosis” to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ-220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 240-276-3151. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written comments concerning this 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.fda.gov/dockets/ecomments* . Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Reena Philip, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 240-276-1286. SUPPLEMENTARY INFORMATION: I. Background Elsewhere in this issue of the **Federal Register** , FDA is publishing a final rule classifying gene expression profiling test systems for breast cancer prognosis into class II (special controls) under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360c(f)(2)). This guidance document will serve as the special control for gene expression profiling test systems for breast cancer prognosis devices. Section 513(f)(2) of the act provides that any person who submits a premarket notification under section 510(k) of the act (21 U.S.C. 360(k)) for a device that has not previously been classified may, within 30 days after receiving an order classifying the device in class III under section 513(f)(1), request FDA to classify the device under the criteria set forth in section 513(a)(1). FDA shall, within 60 days of receiving such a request, classify the device by written order. This classification shall be the initial classification of the device. Within 30 days after the issuance of an order classifying the device, FDA must publish a notice in the **Federal Register** announcing such classification. Because of the timeframes established by section 513(f)(2) of the act, FDA has determined, under § 10.115(g)(2) (21 CFR 10.115(g)(2)), that it is not feasible to allow for public participation before issuing this guidance as a final guidance document. Thus, FDA is issuing this guidance document as a level 1 guidance document that is immediately in effect. FDA will consider any comments that are received in response to this notice to determine whether to amend the guidance document. II. Significance of Guidance This guidance is being issued consistent with FDA's GGPs regulation (§ 10.115). The guidance represents the agency's current thinking on gene expression profiling test systems for breast cancer prognosis. 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 statute and regulations. III. Electronic Access Persons interested in obtaining a copy of the guidance may do so by using the Internet. To receive “Class II Special Controls Guidance Document: Gene Expression Profiling Test System for Breast Cancer Prognosis,” you may either send an e-mail request to *dsmica@fda.hhs.gov* to receive an electronic copy of the document or send a fax request to 240-276-3151 to receive a hard copy. Please use the document number 1627 to identify the guidance you are requesting. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts, **Federal Register** reprints, information on premarket submissions (including lists of approved applications and manufacturers' addresses), small manufacturer's assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH Web site may be accessed at *http://www.fda.gov/cdrh* . A search capability for all CDRH guidance documents is available at *http://www.fda.gov/cdrh/guidance.html* . Guidance documents are also available on the Division of Dockets Management Internet site at *http://www.fda.gov/ohrms/dockets* . IV. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. 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). The collections of information in 21 CFR part 807, subpart E, have been approved under OMB Control No. 0910-0120; the collections of information in 21 CFR part 814 have been approved under OMB Control No. 0910-0231; the collections of information in 21 CFR part 809 have been approved under OMB Control No. 0910-0485; and the collections of information in 21 CFR part 820 have been approved under OMB Control No. 0910-0073. V. 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. Dated: May 1, 2007. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E7-8872 Filed 5-8-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006D-0254] Guidance for Industry: Analytical Methods Description for Type C Medicated Feeds; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of the guidance for industry (#137) entitled “Analytical Methods Description for Type C Medicated Feeds.” This guidance provides our recommendations for describing methods for analyzing new animal drugs in Type C medicated feeds. DATES: Submit written or electronic comments on agency guidances at any time. ADDRESSES: Submit written requests for single copies of the guidance 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 guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Comments should be identified with the full title of the guidance and the docket number found in brackets in the heading of this document. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Rebecca Owen, Center for Veterinary Medicine (HFV-141), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-9842, e-mail: *rebecca.owen@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: I. Background In the **Federal Register** of June 28, 2006 (71 FR 36813), FDA published the notice of availability for a draft guidance entitled “Analytical Methods Description for Type C Medicated Feeds” giving interested persons until September 11, 2006, to comment on the draft guidance. With the exception of one general comment regarding medicated feed, FDA received no specific comments on the guidance. The final guidance has not been substantively changed from the draft version. Section 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b) establishes the requirements for new animal drug approval. FDA regulations in part 514 (21 CFR part 514) specify the information you must submit as part of your new animal drug application

(NADA)and the proper format for the NADA submission. As part of your NADA submission, you must include a “detailed description of the collection of samples and the analytical procedures to which they are subjected” (§ 514.1(b)(5)(vii)). This should include a description of practicable methods of analysis which have adequate sensitivity to determine the amount of the new animal drug in the final dosage form (§ 514.1(b)(5)(vii)(a)). This guidance provides recommendations for describing methods for analyzing new animal drugs in Type C medicated feeds. This guidance applies to instrumental methods only (e.g., high pressure liquid chromatography, gas chromatography). For information on other methods (e.g., microbiological methods) you should contact the Center for Veterinary Medicine (CVM). II. Significance of Guidance This level 1 guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). This guidance represents the agency's current thinking on the topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternate method may be used as long as it satisfies the requirements of applicable statutes and regulations. III. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. 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). The collections of information in § 514.1 have been approved under OMB control numbers 0910-0032 and 0910-0154. IV. Comments Interested persons may, at any time, 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 should be identified with the docket number found in brackets in the heading of this document. A copy of the 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 Copies of the guidance document entitled “Analytical Methods Description for Type C Medicated Feeds” may be obtained from the CVM home page ( *http://www.fda.gov/cvm* ) and from the Division of Dockets Management Web site ( *http://www.fda.gov/ohrms/dockets/default.htm* ). Dated: April 26, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-8808 Filed 5-8-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institutes of Health/National Institute of Environmental Health Sciences Proposed Collection; Comment Request; Program Assessment and Evaluations for NIEHS—Asthma Research *Summary:* 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 National Institute of Environmental Health Sciences, 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:* Program Assessment and Evaluations for NIEHS—Asthma Research. *Type of Information Collection Request:* New. *New and Use of Information Collection:* National Institute of Environmental Health Sciences, Division of Extramural Research and Training (DERT). DERT, with contract support from Battelle Centers for Public Health Research and Evaluation, is examining the impact of its research portfolio. Focusing specifically on one portion of the research portfolio—asthma research—DERT proposes to supplement extant data sources with a primary data collection activity. The purpose of the proposed primary data collection is to obtain information from grantees regarding the impact of their funded asthma research in the short-, intermediate- and long-term. This will be done through a survey of grantees that includes questions about the impact of funding on career development, the field of asthma research, public attitudes, commercial product development, clinical practice, business and industry practices, and long-term human and environmental health. *Frequency of Response:* Once. *Affected Public:* Individuals. *Type of Respondents:* Individuals receiving asthma funding. A 15-minute, close-ended, multi-mode (web and paper) survey will be administered to the universe of NIEHS-funded asthma researchers (N=295) and comparison agency asthma researchers (N=4000). Comparison agencies include other NIH institutes (NICHD, NIAID, NIA, NHLBI), the CDC, AHRQ, and the EPA. The survey development process included formative interviews with a small couple of NIEHS asthma researchers. There are no Capital Costs, Operating Costs and/or Maintenance Costs to report. There are no costs to respondents except for their time to participate. Annualized Burden Table Type of respondents Estimated number of respondents Estimated number of responses per respondent Average burden per response Estimated total annual burden hours requested Asthma grantee 4295 1 .25 1073.75 Total 1073.75 *Request for Comments:* Written comments and/or suggestions from the public and affected agencies should address one or more of the following points:

(1)Evaluate whether the proposed collection of information is necessary for the proper performance of the function 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 the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. *For Further Information:* To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Jerry Phelps, Division of Extramural Research and Training, National Institute of Environmental Health Sciences, P.O. Box 12233, MD ED-21, 111 T.W. Alexander Drive, RTP, NC 27709. Phone:

(919)541-4259. E-mail: *phelps@niehs.nih.gov* . *Comments Due Date:* Comments regarding this information collection are best assured of having their full effect if received within 60-days of the date of this publication. Dated: April 22, 2007. Marc S. Hollander, NIEHS Associate Director for Management. [FR Doc. 07-2285 Filed 5-8-07; 8:45 am]

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