Rules and Regulations. Notice

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BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2001D-0489] (formerly Docket No. 01D-0489) Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a collection of information entitled “Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees” has been approved by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995. 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 the **Federal Register** of December 30, 2005 (70 FR 77403), 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 0910-0581. The approval expires on March 31, 2009. A copy of the supporting statement for this information collection is available on the Internet at *http://www.fda.gov/ohrms/dockets* . Dated: July 21, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-12157 Filed 7-28-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2000D-0084] Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Special Protocol Assessment 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 the information collection in the guidance for industry on special protocol assessment. DATES: Submit written or electronic comments on the collection of information by September 29, 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, rm 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: Elizabeth Berbakos, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1482. 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. Guidance for Industry on Special Protocol Assessment (OMB Control Number 0910-0470)—Extension The “Guidance for Industry on Special Protocol Assessment” describes agency procedures to evaluate issues related to the adequacy (e.g., design, conduct, analysis) of certain proposed studies. The guidance describes procedures for sponsors to request special protocol assessment and for the agency to act on such requests. The guidance provides information on how the agency interprets and applies provisions of the Food and Drug Administration Modernization Act of 1987 and the specific Prescription Drug User Fee Act of 1992 (PDUFA) goals for special protocol assessment associated with the development and review of PDUFA products. The guidance describes two collections of information:

(1)The submission of a notice of intent to request special protocol assessment of a carcinogenicity protocol, and

(2)the submission of a request for special protocol assessment. Notification for a Carcinogenicity Protocol As described in the guidance, a sponsor interested in agency assessment of a carcinogenicity protocol should notify the appropriate division in FDA's Center for Drug Evaluation and Research

(CDER)or the Center for Biologics Evaluation and Research

(CBER)of an intent to request special protocol assessment at least 30 days prior to submitting the request. With such notification, the sponsor should submit relevant background information so that the agency may review reference material related to carcinogenicity protocol design prior to receiving the carcinogenicity protocol. Request for Special Protocol Assessment The guidance asks that a request for special protocol assessment be submitted as an amendment to the investigational new drug application

(IND)for the underlying product and that it be submitted to the agency in triplicate with Form FDA 1571 attached. The guidance also suggests that the sponsor submit the cover letter to a request for special protocol assessment via facsimile to the appropriate division in CDER or CBER. Agency regulations (21 CFR 312.23(d)) state that information provided to the agency as part of an IND is to be submitted in triplicate and with the appropriate cover form, Form FDA 1571. An IND is submitted to FDA under existing regulations in part 312 (21 CFR part 312), which specifies the information that manufacturers must submit so that FDA may properly evaluate the safety and effectiveness of investigational drugs and biological products. The information collection requirements resulting from the preparation and submission of an IND under part 312 have been estimated by FDA and the reporting and recordkeeping burden has been approved by OMB until May 31, 2009, under OMB control number 0910-0014. FDA suggests that the cover letter to the request for special protocol assessment be submitted via facsimile to the appropriate division in CDER or CBER to enable agency staff to prepare for the arrival of the protocol for assessment. The agency recommends that a request for special protocol assessment be submitted as an amendment to an IND for two reasons:

(1)To ensure that each request is kept in the administrative file with the entire IND, and

(2)to ensure that pertinent information about the request is entered into the appropriate tracking databases. Use of the information in the agency's tracking databases enables the appropriate agency official to monitor progress on the evaluation of the protocol and to ensure that appropriate steps will be taken in a timely manner. The guidance recommends that the following information should be submitted to the appropriate Center with each request for special protocol assessment so that the Center may quickly and efficiently respond to the request: •Questions to the agency concerning specific issues regarding the protocol; and •All data, assumptions, and information needed to permit an adequate evaluation of the protocol, including:

(1)The role of the study in the overall development of the drug;

(2)information supporting the proposed trial, including power calculations, the choice of study endpoints, and other critical design features;

(3)regulatory outcomes that could be supported by the results of the study;

(4)final labeling that could be supported by the results of the study; and

(5)for a stability protocol, product characterization and relevant manufacturing data. *Description of Respondents* : A sponsor, applicant, or manufacturer of a drug or biologic product regulated by the agency under the act or section 351 of the Public Health Service Act (42 U.S.C. 262) who requests special protocol assessment. *Burden Estimate* : Table 1 of this document provides an estimate of the annual reporting burden for requests for special protocol assessment. *Notification for a Carcinogenicity Protocol* . Based on data collected from the review divisions and offices within CDER and CBER, including the number of notifications for carcinogenicity protocols and the number of carcinogenicity protocols submitted in fiscal years

(FY)2004 and 2005, CDER estimates that it will receive approximately 45 notifications of an intent to request special protocol assessment of a carcinogenicity protocol per year from approximately 20 sponsors. CBER estimates that it will receive approximately one notification of an intent to request special protocol assessment of a carcinogenicity protocol per year from approximately one sponsor. The hours per response, which is the estimated number of hours that a sponsor would spend preparing the notification and background information to be submitted in accordance with the guidance, is estimated to be approximately 8 hours. *Requests for Special Protocol Assessment* . Based on data collected from the review divisions and offices within CDER and CBER, including the number of requests for special protocol assessment submitted in FY 2004 and FY 2005, CDER estimates that it will receive approximately 364 requests for special protocol assessment per year from approximately 143 sponsors. CBER estimates that it will receive approximately 10 requests from approximately 8 sponsors. The hours per response is the estimated number of hours that a respondent would spend preparing the information to be submitted with a request for special protocol assessment, including the time it takes to gather and copy questions to be posed to the agency regarding the protocol and data, assumptions, and information needed to permit an adequate evaluation of the protocol. Based on the agency's experience with these submissions, FDA estimates approximately 15 hours on average would be needed per response. FDA estimates the burden of this collection as follows: **Table 1.—Estimated Annual Reporting Burden** 1 No. of Respondents No. of Responses per Respondent Total Annual Responses Hours per Response Total Hours Notification for Carcinogenicity Protocols 21 2.19 46 8 368 Requests for Special Protocol Assessment 151 2.48 374 15 5,610 Total 5,978 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: July 21, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-12158 Filed 7-28-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0283] Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Survey of Physicians' Perceptions of the Impact of Early Risk Communication About Medical Products 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 a notice in the **Federal Register** concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on a proposed survey of physicians' perceptions of the impact of early risk communication about medical products. The purpose of the proposed survey is to improve FDA's understanding of how and when physicians get, and would like to get, information about the risk of medical products, and what factors might influence the likelihood of reporting their patients' adverse experiences. Together with other information, the data from this survey will be used to assess FDA's communication efforts concerning early risk communication about medical products, and inform any potential communication-related changes. DATES: Submit written or electronic comments on the collection of information by *September 29, 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, rm. 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: Jonna Capezzuto, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. 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 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 Survey of Physicians' Perceptions of the Impact of Early Risk Communication About Medical Products The authority for FDA to collect the information derives from the FDA Commissioner's authority, as specified in section 903(d)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)). FDA engages in a number of communication activities to inform health care providers about new risks of regulated medical products, including prescription drugs, biologics, and medical devices (for example, pacemakers, implantable cardiac defibrillators, contact lenses, infusion pumps). More recently, FDA's communication activities have also included the general public. Activities include, but are not limited to, communications in medical journals, through the press (press releases, public health advisories), letters to health care providers sent out in cooperation with product manufacturers, and notifications and information sheets about recalls, withdrawals, and new product safety information on FDA's Internet site. Extensive publicity regarding serious side effects from certain commonly used prescription drugs, as well as certain implantable medical devices, has spurred public pressure to make risk information available sooner. In opposition to such public pressures, however, at least some prescribers and medical societies have suggested that early disclosure of potential side effects (emerging risks) may have unintended negative effects on patient care. For FDA to plan informed programmatic communication activities we need better empirical data about the impact of disseminating emerging risk information on providers and patient care. In addition, only limited research addresses specific barriers to physicians reporting patient adverse events either to FDA or product manufacturers. Further, we have no data evaluating FDA's efforts to improve reporting. Given differing perspectives on the value and timing of providing risk information to medical experts and the public at large, FDA believes it is important to assess how well it is communicating with physicians — the health care provider group with primary responsibility for deciding whether to use medical products to address patient problems. This information is critical both to plan programmatic communication activities and to improve the effectiveness of our reporting systems. Therefore, FDA plans to conduct a survey of a nationally representative group of physicians about these issues. The survey will collect information from respondents through computer-assisted telephone interviews conducted by experienced interviewers. FDA expects to have a final sample of 895 physicians, broken down approximately half and half between primary care practitioners (general practice, family practice, general internal medicine, and pediatricians) and specialists. We expect to identify physician specialty groups that are most likely to have been affected by recent publicity over risks of prescription drugs or medical devices. Such groups may include neurologists, psychiatrists, cardiologists, gastroenterologists, dermatologists, allergists, urologists, obstetricians/gynecologists, and geriatricians. Procedures will be used to ensure production of a sample of physicians that is reasonably representative of the population within the United States. The design of the interview questions will be guided by the results of a series of physician focus groups that have recently been completed. The interview will take approximately 15 minutes to administer. Key information to be collected includes the following topics: • The impact on physicians, their patients, and their practices of the disclosure of still uncertain, emerging risks associated with medical products. • How physicians currently receive and ideally would like to receive new risk and benefit information about medical products (for example, at what level of certainty regarding causality and through what communication channels). • How physicians perceive the credibility of FDA and other potential sources of risk and benefit information, including product sponsors, medical societies, and the media. • What FDA might do to increase the likelihood that respondents will report to FDA or to manufacturers serious patient reactions that might be side effects of using medical products. 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 27 (Pretests) 1 27 .25 6.75 995 (Screener) 1 995 .025 24.88 895 (Survey) 1 895 .25 223.75 Total 255.38 1 There are no capital costs or operating and maintenance costs associated with this collection of information. These estimates are based on FDA's and the contractor's experience with previous surveys. The respondents are divided into two groups: Primary care physicians and specialist physicians. We are basing this estimate on 90 percent of the screened physicians being eligible to participate in the survey. Prior to administering the survey with the entire sample, FDA plans to conduct pretests with up to 27 physicians; these are meant to evaluate the clarity and consistency of the survey questionnaire and interview protocol. Dated: July 21, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-12159 Filed 7-28-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0274] Agency Information Collection Activities; Proposed Collection; Comment Request; Establishing and Maintaining a List of United States Dairy Product Manufacturers/Processors With Interest in Exporting to Chile 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 the information collection provisions associated with the guidance document entitled “Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors With Interest in Exporting to Chile.” DATES: Submit written or electronic comments on the collection of information by September 29, 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, rm. 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: Jonna Capezzuto, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget

(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. Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors With Interest in Exporting to Chile (OMB Control Number 0910-0509)—Extension As a direct result of discussions that have been adjunct to the U.S./Chile Free Trade Agreement, Chile has recognized FDA as the competent U.S. food safety authority and has accepted the U.S. regulatory system for dairy inspections. Chile has concluded that it will not require individual inspections of U.S. firms by Chile as a prerequisite for trade, but will accept firms identified by FDA as eligible to export to Chile. Therefore, in the **Federal Register** of June 22, 2005 (70 FR 36190), FDA announced the availability of a revised guidance document entitled “Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors With Interest in Exporting to Chile.” The guidance can be found at *http://www.cfsan.fda.gov/guidance.html* . The guidance document explains that FDA has established a list that is provided to the government of Chile and posted on FDA's Internet site, which identifies U.S. dairy product manufacturers/processors that have expressed interest to FDA in exporting dairy products to Chile, are subject to FDA jurisdiction, and are not the subject of a pending judicial enforcement action (i.e., an injunction or seizure) or a pending warning letter. The term “dairy products,” for purposes of this list, is not intended to cover the raw agricultural commodity raw milk. Application for inclusion on the list is voluntary. However, Chile has advised that dairy products from firms not on this list could be delayed or prevented by Chilean authorities from entering commerce in Chile.The revised guidance explains what information firms should submit to FDA in order to be considered for inclusion on the list and what criteria FDA intends to use to determine eligibility for placement on the list. The document also explains how FDA intends to update the list and how FDA intends to communicate any new information to Chile. Finally, the revised guidance notes that FDA considers the information on this list, which is provided voluntarily with the understanding that it will be posted on FDA's Internet site and communicated to, and possibly further disseminated by, Chile, to be information that is not protected from disclosure under 5 U.S.C. 552(b)(4). Under this guidance, FDA recommends that U.S. firms that want to be placed on the list send the following information to FDA: Name and address of the firm and the manufacturing plant; name, telephone number, and e-mail address (if available) of the contact person; a list of products presently shipped and expected to be shipped in the next 3 years; identities of agencies that inspect the plant and the date of last inspection; plant number and copy of last inspection notice; and, if other than an FDA inspection, copy of last inspection report. FDA requests that this information be updated every 2 years. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 Activity No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours New written requests to be placed on the list 15 1 15 1.5 22.5 Biannual update 55 1 55 1.0 55.0 Occasional updates 25 1 25 0.5 12.5 Total 90 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The estimate of the number of firms that will submit new written requests to be placed on the list, biannual updates and occasional updates is based on the FDA's experience maintaining the list over the past 3 years. The estimate of the number of hours that it will take a firm to gather the information needed to be placed on the list or update its information is based on FDA's experience with firms submitting similar requests. FDA believes that the information to be submitted will be readily available to the firms. To date, over 110 producers have sought to be included on the list. FDA estimates that, each year, approximately 15 new firms will apply to be added to the list. We estimate that a firm will require 1.5 hours to read the guidance, gather the information needed, and to prepare a communication to FDA that contains the information and requests that the firm be placed on the list. Under the revised guidance, every 2 years each producer on the list must provide updated information in order to remain on the list. FDA estimates that each year approximately half of the firms on the list, 55 firms, will resubmit the information to remain on the list. We estimate that a firm already on the list will require 1.0 hours to biannually update and resubmit the information to FDA, including time reviewing the information and corresponding with FDA. In addition, FDA expects that, each year, approximately 25 firms will need to submit an occasional update and each firm will require 0.5 hours to prepare a communication to FDA reporting the change. Dated: July 21, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-12160 Filed 7-28-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006D-0246] Draft Manufactured Food Regulatory Program Standards; Availability; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. SUMMARY: The Food and Drug Administration is correcting a notice that appeared in the **Federal Register** of July 20, 2006. The document announced the availability of a draft document entitled “Manufactured Food Regulatory Program Standards.” The document was published with an incorrect Internet address. This document corrects that error. FOR FURTHER INFORMATION CONTACT: Beverly Kent, Division of Federal-State Relations, Food and Drug Administration, 300 Pearl St., suite 100, Buffalo, NY 14202, 716-541-0331. SUPPLEMENTARY INFORMATION: In FR Doc. E6-11539, appearing on page 41221 in the **Federal Register** of Thursday, July 20, 2006, the following correction is made: 1. On page 41222, in the first column, under the “Electronic Access” caption, the Internet address “http:www.fda.gov.ohrms/dockets/default.htm” is corrected to read “ *http://www.fda.gov/ohrms/dockets/98fr/06d-0246-gdl0001.pdf* ”. Dated: July 25, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-12179 Filed 7-28-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Cooperative Agreement for Poison Prevention Education AGENCY: Health Resources and Services Administration (HRSA), HHS. ACTION: Notice of Single Source Award. SUMMARY: HRSA will be forming a partnership with the Home Safety Council

(HSC)to collaborate on reaching America's low literacy population. Through this project, easy to read and comprehend poison prevention material will be developed and distributed to the public, poison centers, safety and injury prevention professionals, health educators, and first responders. FOR FURTHER INFORMATION CONTACT: Shkeda Johnson, Senior Public Health Analyst, Healthcare Systems Bureau, Division of Healthcare Preparedness, Room 13-103, 5600 Fishers Lane, Rockville, MD 20857. Telephone: 301-443-1210 Email: *sjohnson@hrsa.gov.* SUPPLEMENTARY INFORMATION: *Intended Recipient of the Award:* Home Safety Council. *Amount of the Award:* $100,000. *Authority:* Section 1271 et seq. of the Public Health Service Act, 42 U.S.C. Section 300d-71 et seq. as amended by the Poison Center Stabilization and Enhancement Grant Program. *Project Period:* The period of the award will begin on September 1, 2006, through August 31, 2007. Justification for the Exception to Competition This project will be implemented through a single source cooperative agreement because the HSC is uniquely positioned to immediately undertake and complete the activities within one year. The HSC has existing organizational knowledge and experience in developing materials for the low literacy population through its Home Safety Literacy Project, which this project will be a component; the HSC has an existing relationship with key stakeholders in place for reaching this vulnerable population; and the HSC project director has extensive expertise in poison prevention education. Dated: July 3, 2006. Elizabeth M. Duke, Administrator. [FR Doc. E6-12178 Filed 7-28-06; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Request for Information (RFI): Change in Grant Appendix Materials ACTION: Notice. SUMMARY: The National Institutes of Health

(NIH)and the Agency for Healthcare Research and Quality

(AHRQ)are evaluating guidelines for grant application appendixes in an effort to streamline the application and review processes. This RFI requests input from interested applicants, reviewers and other members of the research community regarding the way appendix materials should be used in the grant submission, review and management process. Comments will be considered in the development of new policies on appendix materials for various grant programs. DATES: Reponses must be received by September 14, 2006 in order to ensure that NIH and AHRQ will be able to consider the comments in developing new policies on appendix materials for various grant programs. FOR FURTHER INFORMATION CONTACT: E-mail inquiries will be accepted at *appendix_comments@od.nih.gov.* SUPPLEMENTARY INFORMATION: Background The goal of changing the guidelines for grant application appendix materials is to encourage applications to be as concise as possible while containing the information needed for expert scientific review. These changes should make application preparation and handling easier for both applicants and reviewers. Current NIH and AHRQ policy indicates that the Appendix may not be used to circumvent the page limitations of the Research Plan. Appended publications may not be used to provide further details of methodologies or preliminary data described in the Research Plan. All applications and proposals for NIH and AHRQ funding must be self-contained. NIH application guide instructions note that the Appendix is sent only to those members of the Scientific Review Group

(SRG)assigned as primary reviewers of the application. Currently, unless otherwise stated in the solicitation, the following materials may be included in a grant application Appendix: • Up to 10 publications or manuscripts accepted for publication, using URL links to publicly accessible journal articles. • Surveys, questionnaires, data collection instruments, clinical protocols, and informed consent documents. • Photographs or color images of gels, micrographs, etc., provided that a photocopy (may be reduced in size) is also included within the 25-page limit of Items a-d of the research plan. No photographs or color images may be included in the Appendix that are not also represented within the Research Plan. Investigators spend much time and energy developing applications to Federal Agencies. It is unclear whether appendix material which may or may not be read by members of the SRG improves current applications. Submission of unnecessary materials with grant applications wastes the time, energy and resources of investigators, applicant institutions, reviewers, and the NIH and AHRQ. Proposed Changes The following changes are being considered for implementation concurrent with NIH/AHRQ's transition to the electronic grant application process and the SF-424 (R&R): • Submission of photographs or color images of gels, micrographs, etc., will not be allowed in the Appendix. Use of the SF-424 (R&R) electronic grant application will permit insertion into the body of the Research Plan high resolution images of the same quality found in scientific publications. • Materials currently submitted in the Appendix which are essential to the review of the application will be submitted as part of the grant application itself. For example, documents such as clinical protocols, informed consent forms, key questionnaires, surveys, and similar items which are needed by the SRG to adequately assess human subjects issues will be submitted as part of the 'Protection of Human Subjects' section of the grant application. • Reprints or preprints of publications or their PDFs will no longer be allowed as part of the Appendix. Links

(URLs)to PubMed Central or publicly available on-line journals will be permitted in the Biographical Sketches, Bibliography & References Cited, and the Research Plan sections of the grant application. Critical information and detail should be included within the Research Plan and cited in the Bibliography & References Cited section and/or figure or table legend(s) to indicate publication status. • Materials specifically designated in the Funding Opportunity Announcement may be included in the Appendix, within identified page limits. It is anticipated that most FOAs will not permit materials to be included in the Appendix. • All members of the SRG will receive copies of the full application including any permitted Appendix materials thereby increasing the equity of the review. Information Requested Information in the following areas will assist the NIH and AHRQ in developing new policies regarding submission of appendix materials. Respondents will be asked to indicate what perspective(s) they represent, i.e. reviewer and/or applicant, institutional official, etc. 1. Is there a need to reduce the material submitted in the Appendix? If yes, please provide specific types of material that could be eliminated. 2. Is there information essential to the application's review that cannot be included in the body of a grant application as proposed? If yes, please describe the material and identify applicable grant program(s). 3. Is it necessary to include reprint and preprint PDFs as appendix material? If yes, please explain. 4. Do you have concerns about discontinuing the submission of photographs or color images in the Appendix of electronic grant applications? If yes, please explain. 5. Will the proposed changes favor or disfavor any specific group of investigators? If yes, please explain. Responses Responses must be submitted electronically at *http://grants.nih.gov/grants/guide/rfi_files/rfi_appendix_add.htm.* The responses for each item should be limited to 500 words. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the Government's assessment of the information received. No basis for claims against the Government shall arise as a result of a response to this request for information or the Government's use of such information as either part of our evaluation process or in developing specifications for any subsequent announcement. Individual responses will be confidential. Any proprietary information should be so marked. Dated: July 24, 2006. Norka Ruiz Bravo, Deputy Director for Extramural Research, National Institutes of Health. [FR Doc. E6-12230 Filed 7-28-06; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5039-N-03] Notice of Proposed Information Collection: Comment Request; Affirmative Fair Housing Marketing

(AFHM)Plan AGENCY: Office of the Assistant Secretary for Fair Housing and Equal Opportunity, HUD. ACTION: Notice. SUMMARY: The proposed information collection requirement described below will be submitted to the Office of Management and Budget

(OMB)for review, as required by the Paperwork Reduction Act of 1995. The Department is soliciting public comments on the subject proposal. DATES: *Comments Due Date:* September 29, 2006. ADDRESSES: Interested persons are invited to submit comments regarding this proposed information collection requirement. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: Surrell Silverman, Reports Liaison Officer, Fair Housing and Equal Opportunity, Department of Housing and Urban Development, 451 7th Street, SW., Room 5216, Washington, DC 20410-2000. FOR FURTHER INFORMATION CONTACT: Shaye Hardy, Program Standards and Compliance Division, Office of Programs, Department of Housing and Urban Development, 451 7th Street, SW., Room 5222, Washington, DC 20410-2000; telephone:

(202)708-2288 (this is not a toll-free number) for copies of the proposed forms and other available documents. Hearing- or speech-impaired individuals may access this number TTY by calling the toll-free Federal Information Relay Service at 1-800-877-8339. SUPPLEMENTARY INFORMATION: The Department is submitting the proposed information collection to OMB for review, as required by the Paperwork Reduction Act of 1995. The notice solicits comments from members of the public and affected agencies concerning the proposed information collection in order to:

(1)Evaluate whether the proposed information collection is necessary for the proper performance of the Department's program functions;

(2)Evaluate the accuracy of the Department's assessment of the paperwork burden that may result from the proposed information collection;

(3)Enhance the quality, utility, and clarity of the information which must be collected; and

(4)Minimize the burden of the information collection on responders, including the use of appropriate automated collection techniques or other forms of information technology (e.g., electronic transmission of data). *Title of Regulation:* Affirmative Fair Housing Marketing Regulations and Affirmative Fair Housing Marketing Compliance Regulations. *OMB Control Number, if applicable;* 2529-0013. *Description of the need for the information and proposed use:* HUD uses this information to assess the adequacy of the applicant's proposed actions to carry out the Affirmative Fair Housing Marketing requirements of 24 CFR 200.600 and review compliance with these requirements under 24 CFR part 108, the AFHM Compliance Regulations. *Agency form numbers, if applicable:* HUD-935.2A Affirmative Fair Housing Marketing Plan (Multifamily) and HUD-935.2B Affirmative Fair Housing Marketing Plan (Single-Family). *Members of affected public:* Applicants for mortgage insurance under the Department's insured single-family and multifamily subsidized and unsubsidized programs. *Estimation of the total numbers of hours needed to prepare the information, collection including number of respondents, frequency of response, and hours of response:* On an annual basis, there are approximately 6,530 respondents, 1 response per respondent, which equals 6,530 total responses for both forms. Each new respondent (300 multifamily + 30 single-family = 330 new respondents annually) should take approximately 3 hours to complete, which equals approximately 990 hours for new respondents annually. HUD has approximately 31,000 multifamily housing insured and subsidized projects in its inventory. Since multifamily housing projects' Affirmative Fair Housing Marketing Plans (Multifamily) (HUD 935.2A) should be reviewed and updated every 5 years, it is estimated that 20 percent of the multifamily housing project inventory (6,200) will review their plans each year. This review will take approximately 1 hour to complete, which equals 6,200 hours for the review of these plans annually. It is also estimated that slightly less than 20 percent of the reviewed plans (approximately 1,200) will need to be updated. The updating of these plans will take approximately 1 hour to complete, which equals approximately 1,200 hours for the updating of these plans annually. The total estimated number of hours needed to prepare this information collection is 8,390 hours. *Status of the proposed information collection:* HUD revised Form HUD-935.2 Affirmative Fair Housing Plan. This revision consists of creating a form to be used by Multifamily Housing

(MFH)and a second form to be used by Single-Family Housing (SFH). This action was taken to make the completion of the form clearer for the MFH and SFH user. The current form has several instances where there are alternative directions. The major difference in the proposed form is that the Office of Fair Housing and Equal Opportunity will have approval authority for the Form HUD-935.2A to be completed by MFH users and the Office of Housing-Single-Family Housing will have approval authority for the Form HUD-935.2B to be completed by SFH users. Authority: Section 3506 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35, as amended. Dated: July 24, 2006. Kim Kendrick, Assistant Secretary for Fair Housing and Equal Opportunity. [FR Doc. 06-6562 Filed 7-28-06; 8:45 am]

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