Notices. Notice

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BILLING CODE 6210-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0133] Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Evaluation of Variations in Content and Format of the Brief Summary in Direct-to-Consumer Print Advertisements for Prescription Drugs AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing an opportunity for public comment on a 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 two studies of consumer evaluations of variations in content and format of the brief summary in direct-to-consumer

(DTC)prescription drug print advertisements. DATES: Submit written or electronic comments on the collection of information by June 26, 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: Karen Nelson, Office Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1482. SUPPLEMENTARY INFORMATION: I. Backround 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 each of 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. Experimental Evaluation of Variations in Content and Format of the Brief Summary in DTC Print Advertisements for Prescription Drugs Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 300u(a)(4)) authorizes FDA to conduct research relating to health information. Section 903(b)(2)(c) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 393(b)(2)(c)) authorizes FDA to conduct research relating to drugs and other FDA-regulated products in carrying out the provisions of the act. Under the act, a drug is misbranded if its labeling or advertising is false or misleading. In addition, section 502(n) of the act (21 U.S.C. 352(n)) specifies that advertisements for prescription drugs and biological products must provide a true statement of information “in brief summary” about the advertised product's “side effects, contraindications, and effectiveness.” The prescription drug advertising regulations (§ 202.1(e)(3)(iii) (21 CFR 202.1(e)(3)(iii))) specify that the information about risks must include “each specific side effect and contraindication” from the advertised drug's approved labeling. The regulation also specifies that the phrase “side effect and contraindication” refers to all of the categories of risk information required in the approved product labeling written for health professionals, including the warnings, precautions, and adverse reactions sections. Thus, every risk in an advertised drug's approved labeling must be included to meet these regulations. In recent years, FDA has become concerned about the adequacy of the brief summary in DTC print advertisements. Although advertising of prescription drugs was once primarily addressed to health professionals, increasingly consumers have become a target audience, as DTC advertising has dramatically increased in the past few years. Results of FDA's 2002 survey on DTC advertising (available at *http://www.fda.gov/cder/ddmac/researchka.htm* ) show that 41 percent of respondents in 2002 reported they do not usually read any of the brief summary that accompanies the main print ad. Use of the brief summary was a function of whether they have an interest in the condition; about 45 percent of those having a particular interest in the advertised drug read all or almost all of the brief summary. Despite their interest, about half of these individuals described the brief summary as somewhat or very hard to understand. Because the regulations do not specify how to include each risk, sponsors can use discretion in fulfilling the brief summary requirement under § 202.1(e)(3)(iii). Frequently, sponsors print in small type, verbatim, the risk-related sections of the approved product labeling (also called the package insert, professional labeling, or prescribing information). This labeling is written for health professionals, using medical terminology. FDA believes that while this is one reasonable way to fulfill the brief summary requirement for print advertisements directed toward health professionals, this method is difficult for consumers to understand and therefore may not be the best approach to communicate this important information to them. In 2004, FDA published a draft guidance entitled “Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements” (available at *http://www.fda.gov/cder/guidance/5669dft.htm* ). This guidance outlined possible options for improving the communication of risk information to consumers in specific promotional pieces. When discussing the current professional prescribing information format, the guidance states that the “volume of the material, coupled with the format in which it is presented... discourages its use and makes the information less comprehensible to consumers.” The draft guidance suggested three possible presentations for the brief summary, including the current prescribing information format, an approved patient package insert, or highlights from the physician labeling rule. In the content study, FDA plans to investigate the role of context in providing useful risk information to consumers. It has been theorized that long lists of minor risks may detract from the understanding of more serious risks, as stated in the draft guidance. Nonetheless, if the risk information is presented with proper supporting context, people may find the information facilitates rather than distracts from the understanding of the risk information. One of the two proposed studies in this notice will investigate the context that may contribute to this facilitation. In addition to context, format also plays a role in the clarity and understanding of the brief summary. FDA proposes to collect information on the usefulness of different formats suggested in the draft guidance. In addition to the patient package insert, which is usually presented in a question and answer format, FDA proposes to test a consumer-friendly highlights format, as well as a format based on the drug facts labeling used for over-the-counter drugs. Data from these two studies will converge to allow a better assessment of various ways to present risk information in a print advertisement for a prescription drug. II. Studies A. Content Study 1. Design Overview This study will employ a between-subjects crossed factorial design using a mall-intercept protocol. Ten print advertisements will be created using two levels of drug side effect information and five levels of context. Thus, the factors will be the amount of side effect information (short; long) and amount of supportive context for the side effect information (paragraph only; paragraph rate; paragraph rate plus placebo rate; chart rate; chart rate plus placebo rate). Other information will be constant across conditions. Respondents who self-identify as being in the target market for the condition will be asked to read a single print advertisement for a new prescription drug. After reading the advertisement, they will be asked questions about their comprehension and evaluation of the information presented in the advertisement. 2. Factors a. *Participants* . Consumers will be screened and recruited by the contractor to be self-identified as being moderately overweight or more. We chose to limit our investigation to this one disease condition (weight loss) because it has a high prevalence rate in the population ( *http://www.cdc.gov/nccdphp/dnpa/obesity/faq.htm* ) and is likely to occur both in males and females. We chose to accept this decrease in generalizability to maximize our ability to detect subtle differences in content variation. Participants will be screened to represent a range of education levels (some college or less; completed college or more). Because the task presumes basic reading abilities, all screened participants will speak English as their primary language and, as appropriate, have reading glasses available when participating in the study. b. *Amount of side effect information* . The number of side effects will be varied to create “short” and “long” levels as follows: Short: “Side effects include a, b, and c. This is not a complete list. Talk to your doctor for more information.” Long: “Side effects include a, b, c, d, e, f, g, and h. Talk to your doctor for more information.” c. *Context* . The context for the side effect information will be varied to create five levels ranging from least supportive to most supportive as follows: Paragraph only: Listing of side effects in paragraph form. Paragraph rate: Listing of side effects and their rate of occurrence in paragraph form. Paragraph rate plus placebo rate: Listing of side effects, their rate of occurrence, and the rate of placebo effects in paragraph form. Chart rate: Listing of side effects and their rate of occurrence in table form. Chart rate plus placebo rate: Listing of side effects, their rate of occurrence, and the rate of placebo effects in table form. 3. Procedure Participants will be shown one ad. Then a structured interview will be conducted with each participant to examine a number of important perceptions about the brief summary, including perceived riskiness of the drug, comprehension of information in the brief summary, and perceived usefulness of brief summary information. Finally, demographic and health care utilization information will be collected. Interviews are expected to last approximately 20 minutes. A total of 900 participants will be involved. This will be a one-time (rather than annual) collection of information. B. Format Study 1. Design Overview This study will employ a between-subjects crossed factorial design using a mall-intercept protocol. Three print advertisements will be created using three different formats: Question and answer, highlights (71 FR 3922, January 24, 2006), and drug facts (21 CFR 201.66 and Appendix A). The information in the formats will be constant across conditions. Participants who self-identify as being in the target market for the condition will be asked to read a single print advertisement for a new prescription drug. After reading the advertisement, they will be asked questions about their comprehension and evaluation of the information presented in the advertisement. 2. Factors a. *Participants* . Consumers will be screened and recruited by the contractor to be self-identified as being moderately overweight or more. As in the content study described previously in this document, we chose to limit our investigation to one disease condition-weight loss. Participants will be screened to represent a range of education levels (some college or less; completed college or more). Because the task presumes basic reading abilities, all screened participants will speak English as their primary language and, as appropriate, have reading glasses available when participating in the study. b. *Type of format* . The format of the information in the brief summary will be varied as follows: Question and answer, highlights, and drug facts. Please refer to Appendix A for examples of the different format variations. 3. Procedure Participants will be shown one ad. Then a structured interview will be conducted with each participant to examine a number of important perceptions about the brief summary, including perceived riskiness of the drug, comprehension of information in the brief summary, and perceived usefulness of brief summary information. Finally, demographic and health care utilization information will be collected. Interviews are expected to last approximately 20 minutes. A total of 300 participants will be involved. This will be a one-time (rather than annual) collection of information. FDA estimates that 1,800 individuals will need to be screened to obtain a respondent sample of 900 for the content study and that 600 individuals will need to be screened to obtain a respondent sample of 300 for the format study. The screener is expected to take 30 seconds, for a total screener burden of 41 hours. The 1,200 respondents in the two studies will then be asked to respond to a series of questions about the advertisement. We estimate the response burden for each of the two studies to be 20 minutes, for a burden of 396 hours. The estimated total burden for this data collection effort is 437 hours. The respondent burden is listed in table 1 of this document. 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 1,800 (content study: screener) 1 1,800 .017 31 900 (content study: questionnaire) 1 900 .33 297 600 (format study: screener) 1 600 .017 10 300 (format study: questionnaire) 1 300 .33 99 Total 437 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: April 18, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-6142 Filed 4-24-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004N-0408] Regulatory Site Visit Training Program; 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 April 11, 2006. The document reannounced the invitation for participation in its Regulatory Site Visit Training Program. The document was published with an incorrect e-mail address. This document corrects that error. FOR FURTHER INFORMATION CONTACT: Joyce A. Strong, Office of Policy (HF-27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7010. SUPPLEMENTARY INFORMATION: In FR Doc. E6-5221, appearing on page 18340 in the **Federal Register** of Tuesday, April 11, 2006, the following correction is made: 1. On page 18340, in the third column, in the last sentence under the “ ADDRESSES ” caption and under the “ FOR FURTHER INFORMATION CONTACT ” caption, the e-mail address is corrected to read *matt@cber.fda.gov* . Dated: April 18, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-6120 Filed 4-24-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Industry Exchange Workshop on Food and Drug Administration Clinical Trial Requirements; Public Workshop; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop; correction. SUMMARY: The Food and Drug Administration is correcting a notice that appeared in the **Federal Register** of March 7, 2006. The document announced a workshop on FDA clinical trial statutory and regulatory requirements. The document was published with an incorrect Internet address. This document corrects that error. FOR FURTHER INFORMATION CONTACT: Joyce A. Strong, Office of Policy (HF-27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7010. SUPPLEMENTARY INFORMATION: In FR Doc. E6-3229, appearing on page 11434 in the **Federal Register** of Tuesday, March 7, 2006, the following correction is made: 1. On page 11434, in the second column, under the “ *Registration* ” caption, the Internet address is corrected to read *http://www.socra.org/html/FDA_Conference.htm* . Dated: April 18, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-6119 Filed 4-24-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006D-0150] Guidance for Sponsors, Institutional Review Boards, Clinical Investigators, and Food and Drug Administration Staff; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of the guidance entitled “Guidance on Informed Consent for *In Vitro* Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable.” This guidance is intended to inform sponsors, institutional review boards, clinical investigators, and agency staff that under circumstances described in the guidance, that FDA does not intend to object to the use in device investigations, without informed consent, of leftover human specimens that are not individually identifiable. FDA intends to include in this policy leftover specimens that are remnants of specimens collected for routine clinical care or analysis that would otherwise have been discarded, specimens obtained from specimen repositories, and specimens that are leftover from specimens previously collected for other unrelated research. This guidance document will be implemented immediately, 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 “Guidance on Informed Consent for *In Vitro* Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable” 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 301-443-8818. 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: Sally Hojvat, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 240-276-0496. SUPPLEMENTARY INFORMATION: I. Background Under FDA's current regulations governing the conduct of *in vitro* diagnostic

(IVD)studies, the definition of human subject includes human specimens (see 21 CFR 812.3(p)). Because these regulations require informed consent for all FDA-regulated human subject research, except in limited circumstances specified in FDA regulations, informed consent is required before specimens can be used in FDA-regulated research (see 21 CFR part 50). This aspect of FDA's human subject protection regulations has created confusion and difficulty for persons developing IVDs. Many clinicians, research hospitals, and companies have viewed the requirement for informed consent for IVD studies using leftover specimens to be unnecessary to protect human subjects and to be overly burdensome and costly. FDA has recently focused on unnecessary obstacles to medical product development. The agency has received comments from trade associations and research institutions that identify the challenge of obtaining informed consent for the use of leftover specimens as an unnecessary obstacle and expense to investigational efforts. When leftover specimens are available, it is often difficult, if not impossible, to locate the donor and obtain consent. The confusion regarding the application of informed consent requirements to IVD studies and concerns about unnecessary obstacles to product development have prompted FDA to issue this guidance document. The agency believes that the policy expressed in this guidance will facilitate product development in a manner consistent with values of human subject protection. FDA intends that the exercise of enforcement discretion expressed in this guidance document begin immediately. In accordance with FDA's GGP regulation (21 CFR 10.115), you may comment on this guidance at any time. The agency will consider your comments and determine whether to revise the guidance at a later date. II. Significance of Guidance This guidance is being issued consistent with FDA's GGP regulation. The guidance represents the agency's current thinking on this 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 alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. III. Electronic Access To receive “Guidance on Informed Consent for *In Vitro* Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable” by fax, call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system. At the second voice prompt, press 1 to order a document. Enter the document number 1588 followed by the pound sign (#). Follow the remaining voice prompts to complete your request. Persons interested in obtaining a copy of the guidance may also do so by using the Internet. 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 contains information collection provisions that are subject to review by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). The collection of information in this guidance was approved under the emergency processing provisions of the PRA and was assigned OMB control number 0910-0582. 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: April 11, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-6145 Filed 4-24-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Advisory Council on Migrant Health; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), notice is hereby given of the following meeting: *Name:* National Advisory Council on Migrant Health. *Dates and Times:* May 21, 2006, 9 a.m. to 1 p.m. May 21, 2006, 2:30 p.m. to 7:30 p.m. (site visit and public hearing). May 22, 2006, 10 a.m. to 6 p.m. *Place:* Westin Riverwalk Hotel, 420 West Market Street, San Antonio, Texas 73205. Telephone:

(210)224-6500. Fax:

(210)444-6000. *Status:* The meeting will be open to the public. *Purpose:* The purpose of the meeting is to discuss services and issues related to the health of migrant and seasonal farmworkers and their families to be able to formulate recommendations to the Secretary of Health and Human Services. There will also be a site visit and public hearing regarding matters that affect the health of migrant farmworkers. *Agenda:* The agenda includes an overview of the Council's general business activities. The Council will also hear presentations from experts on farmworker issues, including the status of farmworkers health at the local and national level. In addition, the Council will be going on a site visit and holding a public hearing at which migrant farmworkers, community leaders, and providers will have the opportunity to testify before the Council regarding matters that affect the health of migrant farmworkers. The site visit and hearing are scheduled for Sunday, May 21, from 2:30 p.m. to 7:30 p.m., at the Community Health Development, Inc., 200 South Evans Street, Uvalde, Texas 78801; telephone

(830)278-5604, extension 200, fax

(830)278-1836. The Council meeting is being held in conjunction with the National Farmworker Health Conference sponsored by the National Association of Community Health Centers, in San Antonio, Texas, during the same period of time. Agenda items are subject to change as priorities indicate. *For Further Information Contact:* Anyone requiring information regarding the Council should contact Gladys Cate, Office of Minority and Special Populations, Bureau of Primary Health Care, Health Resources and Services Administration, 5600 Fishers Lane, Maryland 20857; telephone

(301)594-0367. Dated: April 19, 2006. Tina M. Cheatham, Director, Division of Policy Review and Coordination. [FR Doc. E6-6144 Filed 4-24-06; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center for Complementary & Alternative Medicine; Notice of Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the National Advisory Council for Complementary and Alternative Medicine (NACCAM) meeting. The meetings will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. A portion of the meeting will be closed to the public in accordance with provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and/or contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications and/or contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. *Name of Committee:* National Advisory Council for Complementary and Alternative Medicine. *Date:* June 8, 2006. *Closed:* 9 a.m. to 12 p.m. *Agenda:* Deliberation on grant applications. *Open:* 1 p.m. to 3:30 p.m. *Agenda:* Presentations on current and proposed research. *Place:* National Institutes of Health, 9000 Rockville Pike, Building 31C, 6th Flr., Conference Room 10, Bethesda, MD 20892. *Contact Person:* Martin H. Goldrosen, PhD., Executive Secretary, National Center for Complementary and Alternative Medicine, National Institutes of Health, 6707 Democracy Blvd., Suite 401, Bethesda, MD 20892.

(301)594-2014. This public comments session is scheduled from 3-3:30 p.m. but could change depending on the actual time spent on each agenda item. Each speaker will be permitted 5 minutes for their presentation. Interested individuals and representatives or organizations are requested to notify Dr. Martin H. Goldrosen, National Center for Complementary and Alternative Medicine, NIH, 6707 Democracy Boulevard, Suite 401, Bethesda, Maryland, 20892, 301-594-2014, Fax: 301-480-9970. Letters of intent to present comments, along with a brief description of the organization represented, should be received no later than 5 p.m. on May 29, 2006. Anyone representative of an organization may present oral comments. Any person attending the meeting who does not request an opportunity to speak in advance of the meeting may be considered for oral presentation, if time permits, and at the discretion of the Chairperson. In addition, written comments may be submitted to Dr. Martin H. Goldrosen at the address listed above up to ten calendar days (June 18, 2006) following the meeting. Copies of the meeting agenda and the roster of members will be furnished upon request by contacting Dr. Martin H. Goldrosen, Executive Secretary, NACCAM, National Center for Complementary and Alternative Medicine, National Institutes of Health, 6707 Democracy Boulevard, Suite 401, Bethesda, Maryland 20892, 301-594-2014, Fax 301-480-9970, or via e-mail at *naccames@mail.nih.gov* . In the interest of security, NIH has instituted stringent procedures for entrance into the building by nongovernment employees. Persons without a government I.D. will need to show a photo I.D. and sign-in at the security desk upon entering the building. Dated: April 17, 2006. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 06-3872 Filed 4-24-06; 8:45 am]

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