Notices. Meeting announcement and request for comments

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BILLING CODE 4140-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Toxicology Program (Ntp); Center for the Evaluation of Risks to Human Reproduction (CERHR); Announcement of the Second Bisphenol A Expert Panel Meeting AGENCY: National Institute of Environmental Health Sciences (NIEHS); National Institutes of Health. ACTION: Meeting announcement and request for comments. SUMMARY: CERHR announces the second meeting of the CERHR Expert Panel on Bisphenol A on August 6-8, 2007, at the Hilton Alexandria Old Town in Alexandria, VA.

This meeting is open to the public with time scheduled for oral public comment. Attendance is limited only by the available meeting space. DATES: The second expert panel meeting on bisphenol A will be held August 6-8, 2007. The interim draft expert panel report containing sections 1-4 is currently available for public comment [ **Federal Register** , May 1, 2007 (Vol. 72, No. 83, pages 23833-4)]. Written public comments on the interim draft report must be received by June 20, 2007.

July 30, 2007 is the deadline for pre-registration to attend the meeting, to pre-register to provide oral comments, and to submit written materials intended to supplement the oral remarks. ADDRESSES: The second expert panel meeting will be held at the Hilton Alexandria Old Town, 1767 King Street, Alexandria, VA (located across the street from the King Street Metro Stop). Written comments should be sent to Dr. Michael D. Shelby, CERHR Director [NIEHS, P.O. Box 12233, MD EC-32, Research Triangle Park, NC 27709 (mail),

(919)316-4511 (fax), or *shelby@niehs.nih.gov* (e-mail)]. Courier address: CERHR, 79 T.W. Alexander Drive, Building 4401, Room 103, Research Triangle Park, NC 27709. FOR FURTHER INFORMATION CONTACT: Dr. Michael D. Shelby, CERHR Director, 919-541-3455, *shelby@niehs.nih.gov.* SUPPLEMENTARY INFORMATION: Background CERHR convened the expert panel on March 5-7, 2007 to complete its report on the potential reproductive and developmental hazards of bisphenol A. The panel discussed and made revisions to the draft expert panel report, but because of the length and complexity of this evaluation, the panel was unable to complete its task. Information about the meeting and the draft interim expert panel report, which shows all edits to date, are available on the CERHR Web site ( *http://cerhr.niehs.nih.gov/chemicals/bisphenol/bisphenol.html* ). The expert panel will reconvene on August 6-8, 2007, for a second meeting at the Hilton Alexandria Old Town, 1767 King Street, Alexandria, VA. The meeting will begin each day at 8:30 a.m. and continue until adjournment. It is anticipated to adjourn by noon on August 8, although adjournment may occur earlier or later depending upon the time needed for the expert panel to complete its work. The expert panel will

(1)continue its review,

(2)finalize sections 1-4 of the draft report,

(3)reach conclusions regarding whether exposure to bisphenol A is a hazard to human reproduction or development, and

(4)write Section 5 Summary, Conclusions, and Critical Data Needs. The interim draft report will serve as the starting point for the expert panel's discussions at its August meeting. Bisphenol A (CAS RN: 80-5-07) is a high production volume chemical used in the production of epoxy resins, polyester resins, polysulfone resins, polyacrylate resins, polycarbonate plastics, and flame retardants. Polycarbonate plastics are used in food and drink packaging; resins are used as lacquers to coat metal products such as food cans, bottle tops, and water supply pipes. Some polymers used in dental sealants and tooth coatings contain bisphenol A. Exposure to the general population can occur through direct contact to bisphenol A or by exposure to food or drink that has been in contact with a material containing bisphenol A. CERHR selected this chemical for evaluation because of

(1)high production volume,

(2)widespread human exposure,

(3)evidence of reproductive toxicity in laboratory animal studies, and

(4)public concern. Request for Comments The CERHR again invites written public comments on the interim draft expert panel report on bisphenol A. All public comments received on the interim draft report will be posted on the CERHR Web site prior to the August meeting and distributed to all expert panel members for their consideration in revising the interim draft report and/or preparing for the second meeting. Persons submitting written comments are asked to include their name and contact information (affiliation, mailing address, telephone and facsimile numbers, e-mail, and sponsoring organization, if any) and send them to Dr. Shelby (see ADDRESSES above) for receipt by June 20, 2007. Time will be set aside on August 6, 2007, for the presentation of oral public comments at the expert panel meeting. Seven minutes will be available for each speaker (one speaker per organization). Persons wishing to make oral remarks are asked to contact CERHR by July 30 (see ADDRESSES above) and, if possible, send a copy of the PowerPoint slides, statement, or talking points by July 30. When registering to comment orally, please provide your name, affiliation, mailing address, telephone and facsimile numbers, e-mail and sponsoring organization (if any). Any written statement will be provided to the expert panel members to assist them in identifying issues for discussion and noted in the meeting record. Registration for presentation of oral comments will also be available at the meeting on August 6, 2007, from 7:30-8:30 a.m. Persons registering at the meeting are asked to bring 20 copies of their statement or talking points for distribution to the expert panel and for the record. Background Information on CERHR NTP established CERHR in June 1998 [ **Federal Register** , December 14, 1998 (Volume 63, Number 239, page 68782)]. CERHR is a publicly accessible resource for information about adverse reproductive and/or developmental health effects associated with exposure to environmental and/or occupational exposures. CERHR follows a formal, multi-step process for review and evaluation of selected chemicals. Expert panels conduct scientific evaluations of agents selected by the CERHR in public forums. CERHR invites the nomination of agents for review or scientists for its expert registry. Information about CERHR and the nomination process can be obtained from its homepage ( *http://cerhr.niehs.nih.gov* ) or by contacting Dr. Shelby (see FOR FURTHER INFORMATION CONTACT above). CERHR selects chemicals for evaluation based upon several factors including production volume, potential for human exposure from use and occurrence in the environment, extent of public concern, and extent of data from reproductive and developmental toxicity studies. CERHR follows a formal, multi-step process for review and evaluation of selected chemicals. Information about the process and CERHR is available on the CERHR Web site under “About CERHR” or in printed copy from CERHR. Dated: June 6, 2007. Samuel H. Wilson, Deputy Director, National Institute of Environmental Health Sciences and National Toxicology Program. [FR Doc. E7-11590 Filed 6-14-07; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Meetings of the Advisory Committee for Injury Prevention and Control (ACIPC), and Its Subcommittee, the Science and Program Review Subcommittee In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention

(CDC)announces the following meetings of the aforementioned subcommittee and committee. *Name:* Science and Program Review Subcommittee (SPRS). *Times and Date:* 10:30 a.m.-10:45 a.m., July 12, 2007 (Open). 10:45 a.m.-2:45 p.m., July 12, 2007 (Closed). *Place:* Koger Center, Yale Building, Room 1081, 2945 Flowers Road, South, Atlanta, GA 30341. *Purpose:* The Science and Program Review Subcommittee provides advice on the needs, structure, progress and performance of programs of the National Center for Injury Prevention and Control (NCIPC). *Matters To Be Discussed:* The subcommittee will meet July 12, 2007, to provide a secondary review of, discuss, and evaluate the individual research grant and cooperative agreement applications submitted in response to two Fiscal Year 2007 Requests for Applications

(RFAs)related to the following individual research announcements: 07002, Family and Dyadic Focused Interventions to Prevent Intimate Partner Violence; 07003, Maximizing Protective Factors for Youth Violence; 07004, Abusive Head Trauma Prevention; 07005, Understanding Bullying and Sexual Violence Perpetration and Factors Associated with Both Outcomes; 07006, Grants for Traumatic Injury Biomechanics Research; 07007, Dissemination Research on Fall Prevention: “Stepping On” in a U.S. Community Setting; and 07008, The Impact of Traumatic Brain Injury Among Incarcerated Persons. Following this meeting, the voting members of ACIPC will meet via teleconference to vote on the recommendations of the SPRS regarding the RFAs. This call will take place on July 12 from 3 p.m.-4:30 p.m. *Name:* Advisory Committee for Injury Prevention and Control. *Times and Date:* 3 p.m.-3:15 p.m., July 12, 2007 (Open). 3:15 p.m.-4:30 p.m., July 12, 2007 (Closed). *Place:* Koger Center, Yale Building, Room 1081, 2945 Flowers Road, South, Atlanta, GA 30341. *Purpose:* The committee advises and makes recommendations to the Secretary, Department of Health and Human Services, the Director, Centers for Disease Control and Prevention, and the Director, National Centers for Injury Prevention and Control regarding feasible goals for the prevention and control of injury. The committee makes recommendations regarding policies, strategies, objectives, and priorities, and reviews progress toward injury prevention and control. *Matters to be Discussed:* Agenda items for the open portion include the call to order and introductions and request for public comments. Beginning at 3:15 p.m., July 12, 2007, through 4:30 p.m, during the closed portion, the Committee will vote on the results of the secondary review. This portion of the meeting will be closed to the public in accordance with the provisions set forth in section 552b(c)(4) and (b), title 5 U.S.C., and the Determination of the Acting Director, Management Analysis and Services Office, CDC pursuant to Pub L. 92-463. Agenda items are subject to change as priorities dictate. *Contact Person for More Information:* Ms. Amy Harris, Executive Secretary, ACIPC, NCIPC, CDC, 4770 Buford Highway, NE, M/S K61, Atlanta, Georgia 30341-3724, telephone

(770)488-4936. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: May 31, 2007. Elaine L. Baker, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E7-11555 Filed 6-14-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10117, 10118, 10119, 10135, 10136, 10214, and CMS-10216] Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY: Centers for Medicare & Medicaid Services, Department of Health and Human Services. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services, is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects:

(1)The necessity and utility of the proposed information collection for the proper performance of the Agency's function;

(2)the accuracy of the estimated burden;

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

(MA)Application Coordinated Care Plans (CMS-10117), Medicare Advantage

(MA)Application Private Fee-For-Service Plans (CMS-10118); Medicare Advantage

(MA)Application Regional PPO Plans (CMS-10119); Medicare Advantage

(MA)Application Service Area Expansion

(SAE)for Coordinated Care Plans: Private Fee For Service Plans (CMS-10135); Medical Savings Account Plans (CMS-10136), and Employer Group Waiver Plans (CMS-10214); *Form Number:* CMS-10117, 10118, 10119, 10135, 10136 and 10214 (OMB#: 0938-0935); *Use:* An entity seeking a contract as an MA organization must be able to provide Medicare's basic benefits plus meet the organizational requirements set out under the regulations at 42 CFR Part 422. An applicant must demonstrate that it can meet the benefit and other requirements within the specific geographic area it is requesting. The application forms are designed to give CMS the information needed to determine a health plan's compliance with the regulations at 42 CFR Part 422. The MA application forms will be used by CMS to determine whether an entity is eligible to enter into a contract to provide services to Medicare beneficiaries; *Frequency:* Reporting—Once; *Affected Public:* Business or other for-profit and not-for-profit institutions; *Number of Respondents:* 220; *Total Annual Responses:* 220; *Total Annual Hours:* 5580. 2. *Type of Information Collection Request:* Extension without change of a currently approved collection; *Title of Information Collection:* Alternative Benefits State Plan Amendment Health Opportunity Accounts

(HOA)Demonstration Program; *Use:* The DRA provides States with numerous flexibilities in operating their State Medicaid programs. For example, Section 6082 of the DRA allows up to 10 States to operate Medicaid demonstrations to test alternative systems for delivering their Medicaid benefits. Under these demonstrations, States would have the flexibility to deliver their Medicaid benefits to volunteer beneficiaries through a program that is comprised of an HOA and a High Deductible Health Plan (HDHP). Under the DRA, States can submit a State Plan Pre-print to CMS to effectuate this change to their Medicaid programs. CMS will provide a State Medicaid Director letter providing guidance on this provision and the implementation of the DRA and the associated State Plan Amendment template for use by States to modify their Medicaid State Plans if they choose to implement this flexibility; *Form Number:* CMS-10216 (OMB#: 0938-1007); *Frequency:* Reporting: One-time; *Affected Public:* State, Local or Tribal Government; *Number of Respondents:* 56; *Total Annual Responses:* 10; *Total Annual Hours:* 10. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS Web Site address at *http://www.cms.hhs.gov/PaperworkReductionActof1995* , or e-mail your request, including your address, phone number, OMB number, and CMS document identifier, to *Paperwork@cms.hhs.gov* , or call the Reports Clearance Office on

(410)786-1326. Written comments and recommendations for the proposed information collections must be mailed or faxed within 30 days of this notice directly to the OMB desk officer: OMB Human Resources and Housing Branch, Attention: Carolyn Lovett, New Executive Office Building, Room 10235, Washington, DC 20503, Fax Number:

(202)395-6974. Dated: June 8, 2007. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E7-11467 Filed 6-14-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-R-216, CMS-R-262, CMS-10173, and CMS-R-308] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Centers for Medicare & Medicaid Services, Department of Health and Human Services. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services

(CMS)is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects:

(1)The necessity and utility of the proposed information collection for the proper performance of the agency's functions;

(2)the accuracy of the estimated burden;

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

(4)the use of automated collection techniques or other forms of information technology to minimize the information collection burden. 1. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* Issuance of Advisory Opinions Concerning Physicians' Referrals; *Use:* Section 1877(g)(6) of the Social Security Act (the Act), requires that the Department of Health and Human Services issue advisory opinions concerning whether the referral of a Medicare patient by a physician for certain designated health services (other than clinical laboratory services) is prohibited under the physician referral provisions of the Social Security Act. Section 1877(g)(6) of the Act requires that the Department of Health and Human Services accept requests for advisory opinions made after November 3, 1997 and before August 21, 2000. Section 543 of the Benefits Improvement and Protection Act of 2001, Public Law 106-554, extended indefinitely the period during which the Department of Health and Human Services accepts requests for these advisory opinions. The collection of information contained in 42 CFR 411.372 and 411.373 is necessary to comply with this statutory mandate, and allow CMS to consider requests for advisory opinions and provide accurate and useful opinions. *Form Number:* CMS-R-216 (OMB#: 0938-0714); *Frequency:* Once; *Affected Public:* Business or other for-profit and not-for-profit institutions; *Number of Respondents:* 50 *Total Annual Responses:* 50; *Total Annual Hours:* 1,000. 2. *Type of Information Collection Request:* Revision of a currently approved collection; *Title of Information Collection:* Plan Benefit Package

(PBP)and Formulary Submission for Medicare Advantage

(MA)Plans and Prescription Drug Plans (PDP); *Use:* CMS requires that MA and PDP organizations submit a completed formulary and PBP as part of the annual bidding process. During this process, organizations prepare their proposed plan benefit packages for the upcoming contract year and submit them to CMS for review and approval. To see the comprehensive list of changes from CY2007 to CY2008, please refer to the document entitled “Appendix B—PBP-Formulary CY2008 List of Changes.” *Form Number:* CMS-R-262 (OMB#: 0938-0763); *Frequency:* Yearly; *Affected Public:* Business or other for-profit and not-for-profit institutions; *Number of Respondents:* 450 *Total Annual Responses:* 4725; *Total Annual Hours:* 10,800. 3. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* Individuals Authorized Access to the CMS Computer Services (IACS); *Form Number:* CMS-10173 (OMB#: 0938-0989) *Use:* The Centers for Medicare and Medicaid Services

(CMS)is requesting the Office of Management and Budget

(OMB)approval of the Individuals Authorized to Customer Service Application for Access to CMS Computer Systems. The IACS system provides a centralized user provisioning and administration service that supports the creation, deletion, and lifecycle management of enterprise identities. This service creates accounts, supports Role Based Access Control (RBAC), the form flow approval process and enterprise identity audit and recertification, and provides business application integration points. An application integration point allows business application owners to use the form flow process of the user provisioning service to approve or deny requests for access to business applications. The primary purpose of this system is to implement a unified framework for managing user information and access rights, for those individuals who apply for and are granted access across multiple CMS systems and business contexts. Information in this system will also be used to:

(1)Support regulatory and policy functions performed within the Agency or by a contractor or consultant;

(2)support constituent requests made to a Congressional representative; and

(3)to support litigation involving the Agency related to this system. Although the Privacy Act requires only that the “routine use” portion of the system be published for comment, CMS invites comments on all portions of this notice. *Frequency:* As required; *Affected Public:* Individuals or households; Business or other for-profit and not-for-profit; State, Local or Tribal governments; *Number of Respondents:* 60,000,000 *Total Annual Responses:* 15,000,000; *Total Annual Hours:* 15,000,000. 4. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* State Children's Health Insurance Program and Supporting Regulations in 42 CFR 431.636, 457.50, 457.60, 457.70, 457.340, 457.350, 457.431, 457.440, 457.525, 457.560, 457.570, 457.740, 457.750, 457.810, 457.940, 457.945, 457.965, 457.985, 457.1005, 457.1015, and 457.1180; *Form Number:* CMS-R-308 (OMB#: 0938-0841) *Use:* States are required to submit title XXI plans and amendments for approval by the Secretary pursuant to section 2102 of the Social Security Act in order to receive funds for initiating and expanding health insurance coverage for uninsured children. States are also required to submit State expenditure and statistical reports, annual reports and State evaluations to the Secretary as outlined in title XXI of the Social Security Act. *Frequency:* Yearly and quarterly; *Affected Public:* State, Local or Tribal governments; *Number of Respondents:* 56; *Total Annual Responses:* 1,454,601; *Total Annual Hours:* 864,933. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS' Web Site address at *http://www.cms.hhs.gov/PaperworkReductionActof1995* , or E-mail your request, including your address, phone number, OMB number, and CMS document identifier, to *Paperwork@cms.hhs.gov* , or call the Reports Clearance Office on

(410)786-1326. To be assured consideration, comments and recommendations for the proposed information collections must be received at the address below, no later than 5 p.m. on August 14, 2007. CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development—C, Attention: Bonnie L Harkless, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Dated: June 7, 2007. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E7-11468 Filed 6-14-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0220] Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Drug User Fee Cover Sheet, FDA Form 3546 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 hourly burden necessary to complete FDA Form 3546, “Animal Drug User Fee Cover Sheet.” DATES: Submit written or electronic comments on the collection of information by August 14, 2007. 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: Denver Presley, Jr., Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget

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

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

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

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

(4)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Animal Drug User Fee Cover Sheet; FDA Form 3546; 21 U.S.C. 379j-12 (OMB Control Number 0910-0539)—Extension Under Section 740 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-12), as amended by the Animal Drug User Fee Act of 2003 (ADUFA), FDA has the authority to assess and collect for certain animal drug user fees. Because the submission of user fees concurrently with applications and supplements is required, review of an application cannot begin until the fee is submitted. The types of fees that require a cover sheet are certain animal drug application fees and certain supplemental animal drug application fees. The cover sheet, FDA Form 3546, is designed to provide the minimum necessary information to determine whether a fee is required for the review of an application or supplement, to determine the amount of the fee required, and to assure that each animal drug user fee payment and each animal drug application for which payment is made, is appropriately linked to that payment. The form, when completed electronically, will result in the generation of a unique payment identification number used for tracking the payment. FDA will use the information collected to initiate administrative screening of new animal drug applications and supplements to determine if payment has been received. Respondents to this collection of information are new animal drug sponsors, applicants, or manufacturers. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 21 U.S.C. 379j-12 Number of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 740(a)(1) FDA Form 3546 (Cover Sheet) 69 1 time for each application 69 1 69 1 There are no capital costs or operating and maintenance costs associated with this collection of information Based on FDA's database system, there are an estimated 140 manufacturers of products or sponsors of new animal drugs potentially subject to ADUFA. However, not all manufacturers or sponsors will have any submissions in a given year and some may have multiple submissions. The total number of annual responses is based on the number of submissions received by FDA in fiscal year 2003. The Center for Veterinary Medicine estimates 69 annual responses that include the following: 28 new animal drug premarket approval applications and 41 supplements. The estimated hours per response are based on past FDA experience with the various submissions, and range from 30 minutes to 1 hour. The hours per response are based on the average of these estimates. Dated: June 8, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-11527 Filed 6-14-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0050] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Label Comprehension Study AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a proposed collection of information has been submitted to the Office of Management and Budget

(OMB)for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by July 16, 2007. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974. All comments should be identified with the OMB control number 0910-NEW and title “Label Comprehension Study.” Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Label Comprehension Study (U.S.C. 393(d)(2)(C)) FDA issued the “Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Labeling for Male Condoms Made of Natural Rubber Latex” on November 14, 2005 (70 FR 69156). Section 21 U.S.C. 393(d)(2)(C) of the Federal Food, Drug and Cosmetic Act (the act) states that the Secretary, through the Commissioner, shall be responsible to conduct research relating to * * * devices in carrying out this chapter. In order to evaluate the understandability of the condom labeling language currently on the market and the labeling language proposed in this draft guidance, as well as a future revised version of the labeling, FDA plans to evaluate readers' comprehension of three versions of condom labeling through a label comprehension study. The proposed label comprehension study will measure current and potential condom consumers' understanding of the current market labeling and the proposed condom labeling in the draft guidance of the retail package, foil and package insert of condom labeling, as well as a future revised version of the labeling. The label comprehension study will follow a sequential design, first testing both the current market labeling (Part A) and the draft labeling in the guidance (Part B) in Stage 1, and then a revised version of the labeling in Stage 2. FDA will conduct a label comprehension study via a mall intercept/central location intercept methodology with pre-screened participants. The FDA will administer a screening instrument, the Rapid Estimate of Adult Literacy in Medicine (REALM) test, an informed consent, and a questionnaire with approximately 20 questions related to the condom labeling language to a total of 1,200 participants: 400 participants for Part A of Stage 1, 400 participants for Part B of Stage 1, and 400 participants for Stage 2 of the study. Results of the study will be considered in FDA's condom labeling recommendations to provide important risk/benefit and use information associated with condoms in an easily understood language. In the **Federal Register** of February 16, 2007 (72 FR 7661), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. FDA estimates the burden for 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 Screening Tool 3,300 1 3,300 .05 165 Stage 1: Part A - REALM test; Informed Consent; Read Labeling; Questionnaire 400 1 400 .45 180 Stage 1: Part B - REALM test; Informed Consent; Read Labeling; Questionnaire 400 1 400 .45 180 Stage 2 - REALM test; Informed Consent; Read Labeling; Questionnaire 400 1 400 .45 180 Total 705 1 There are no capital costs or operating and maintenance costs associated with this collection of information. This was based on similar types of FDA studies conducted in the past. FDA has conducted both focus group studies and label comprehension studies, where similar participant activities, such as reading the labeling, taking the REALM test, signing the informed consent, and answering questions on a self-administered questionnaire took place. In order to achieve the 1,200 participants for the condom label comprehension study, FDA estimates screening 3,300 to achieve 1,200 interviews. Dated: June 8, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-11528 Filed 6-14-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection Comment Request In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104-13), the Health Resources and Services Administration

(HRSA)will publish periodic summaries of proposed projects being developed for submission to OMB under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans, call the HRSA Reports Clearance Officer on

(301)443-1129. Comments are invited on:

(a)Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;

(b)the accuracy of the agency's estimate of the burden of the proposed collection of information;

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

(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques of other forms of information technology. Proposed Project: The Nursing Education Loan Repayment Program Application (OMB No. 0915-0140)—Revision This is a request for revision of the Nursing Education Loan Repayment Program (NELRP) application and participant monitoring forms. The NELRP was originally authorized by 42 U.S.C. 297b(h) (section 836(h) of the Public Health Service Act) as amended by Public Law 100-607, November 4, 1988. The NELRP is currently authorized by 42 U.S.C. 297n (section 846 of the Public Health Service Act) as amended by Public Law 107-205, August 1, 2002. Under the NELRP, registered nurses are offered the opportunity to enter into a contractual agreement with the Secretary to receive loan repayment for up to 85 percent of their qualifying educational loan balance as follows: 30 percent each year for the first 2 years and 25 percent for the third year. In exchange, the nurses agree to serve full-time as a registered nurse for 2 or 3 years at a health care facility with a critical shortage of nurses. NELRP requires the following information: 1. Applicants must provide information on their nursing education, employment, and proposed service site; 2. Applicants must provide information on their outstanding nursing educational loans; 3. Applicants must provide banking information from their financial institution; and 4. Employers must provide information on the health care facility and on the employment status of applicants and participants. Form Number of respondents Responses per respondents Total responses Hours per response Total burden hours Estimates of Annualized Hour Burden are as Follows for Applicants: NELRP Application 5,000 1 5,000 1.5 7,500 Loan Verification Form 5,000 3 15,000 1 15,000 Applicant Employment Verification Form 5,000 1 5,000 .5 2,500 Payment Information Form 5,000 1 5,000 1 5,000 Application Checklist 5,000 1 5,000 .5 2,500 Pre-Award Confirmation Checklist 600 1 600 .25 150 Total 5,000 35,600 32,650 Estimates of Annualized Hour Burden are as Follows for Participants: Participant Semi-Annual Employment Verification Form 1,300 2 2,600 .5 1,300 Total 1,300 2 2,600 .5 1,300 Send comments to Susan G. Queen, Ph.D., HRSA Reports Clearance Officer, Room 10-33 Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857. Written comments should be received with 60 days of this notice. Dated: June 11, 2007. Caroline Lewis, Associate Administrator for Management. [FR Doc. E7-11557 Filed 6-14-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Advisory Commission of Childhood Vaccines; Request for Nominations for Voting Members AGENCY: Health Resources and Services Administration, HHS. ACTION: Notice. SUMMARY: The Health Resources and Services Administration

(HRSA)is requesting nominations to fill three vacancies on the Advisory Commission on Childhood Vaccines (ACCV). The ACCV was established by Title XXI of the Public Health Service Act (the Act), as enacted by Public Law (Pub. L.) 99-660 and as subsequently amended, and advises the Secretary of Health and Human Services (the Secretary) on issues related to implementation of the National Vaccine Injury Compensation Program (VICP). DATES: The agency must receive nominations on or before July 16, 2007. ADDRESSES: All nominations are to be submitted to the Director, Division of Vaccine Injury Compensation, Healthcare Systems Bureau (HSB), HRSA, Parklawn Building, Room 11C-26, 5600 Fishers Lane, Rockville, Maryland 20857. FOR FURTHER INFORMATION CONTACT: Ms. Delia Jones, Principal Staff Liaison, Policy Analysis Branch, Division of Vaccine Injury Compensation, HSB, HRSA at

(301)443-6593 or e-mail: *djones2@hrsa.gov.* SUPPLEMENTARY INFORMATION: Under the authorities that established the ACCV, the Federal Advisory Committee Act of October 6, 1972 (Pub. L. 92-463) and section 2119 of the Act, 42 U.S.C. 300aa-19, as added by Public Law 99-660 and amended, HRSA is requesting nominations for three voting members of the ACCV. The ACCV advises the Secretary on the implementation of the VICP. The activities of the ACCV include: recommending changes in the Vaccine Injury Table at its own initiative or as the result of the filing of a petition; advising the Secretary in implementing section 2127 regarding the need for childhood vaccination products that result in fewer or no significant adverse reactions; surveying Federal, State, and local programs and activities related to gathering information on injuries associated with the administration of childhood vaccines, including the adverse reaction reporting requirements of section 2125(b); advising the Secretary on the methods of obtaining, compiling, publishing, and using credible data related to the frequency and severity of adverse reactions associated with childhood vaccines; and recommending to the Director of the National Vaccine Program that vaccine safety research be conducted on various vaccine injuries. The ACCV consists of nine voting members appointed by the Secretary as follows:

(1)Three health professionals, who are not employees of the United States Government and have expertise in the health care of children, and the epidemiology, etiology, and prevention of childhood diseases, and the adverse reactions associated with vaccines, at least two shall be pediatricians;

(2)three members from the general public, at least two shall be legal representatives (parents or guardians) of children who have suffered a vaccine-related injury or death; and

(3)three attorneys, at least one shall be an attorney whose specialty includes representation of persons who have suffered a vaccine-related injury or death, and one shall be an attorney whose specialty includes representation of vaccine manufacturers. In addition, the Director of the National Institutes of Health, the Assistant Secretary for Health, the Director of the Centers for Disease Control and Prevention, and the Commissioner of the Food and Drug Administration (or the designees of such officials) serve as nonvoting ex officio members. Specifically, HRSA is requesting nominations for three voting members of the ACCV representing:

(1)A pediatrician who has expertise in the health care of children, the epidemiology, etiology, and prevention of childhood diseases, and the adverse reactions associated with vaccines;

(2)a member of the general public who is the legal representative of a child who has suffered a vaccine injury or death; and

(3)an attorney whose specialty includes representation of persons who have suffered vaccine injuries or deaths. Nominees will be invited to serve a 3-year term beginning January 1, 2008, and ending December 31, 2010. Interested persons may nominate one or more qualified persons for membership on the ACCV. Nominations shall state that the nominee is willing to serve as a member of the ACCV and appears to have no conflict of interest that would preclude the ACCV membership. Potential candidates will be asked to provide detailed information concerning consultancies, research grants, or contracts to permit evaluation of possible sources of conflicts of interest. A curriculum vitae or resume should be submitted with the nomination. The Department of Health and Human Services has special interest in assuring that women, minority groups, and the physically disabled are adequately represented on advisory committees; and therefore, extends particular encouragement to nominations for appropriately qualified female, minority, or disabled candidates. Dated: June 11, 2007. Caroline Lewis, Associate Administrator for Management. [FR Doc. E7-11548 Filed 6-14-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Notice of Meeting: Secretary's Advisory Committee on Genetics, Health, and Society Pursuant to Public Law 92-463, notice is hereby given of the thirteenth meeting of the Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS), U.S. Public Health Service. The meeting will be held from on Tuesday, July 10, 2007, from 8:30 a.m. to approximately 5 p.m. in Room 800 of the Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20001. The meeting will be open to the public with attendance limited to space available. The meeting also will be Web cast. The meeting will focus primarily on the issue of gene patents and licensing practices and consist of a series of presentations and discussions involving international experts on how other countries are addressing questions related to the impact of gene patents and licensing practices on patient access to genetic tests. In addition, the SACGHS task force on oversight of genetic testing will present a brief report on the progress of its fact-finding and consultative efforts with regard to the Secretary's charge. The Committee will also be updated about the public comments received in response to the Committee's solicitation on its draft report on pharmacogenomics. Time will be provided for public comments. The Committee would welcome hearing from anyone wishing to provide public comment on any issue related to genetics, health, and society. Individuals who would like to provide public comment should notify the SACGHS Executive Secretary, Ms. Sarah Carr, by telephone at 301-496-9838 or e-mail at *carrs@od.nih.gov.* The SACGHS office is located at 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892. Anyone planning to attend the meeting who is in need of special assistance, such as sign language interpretation or other reasonable accommodations, is also asked to contact the Executive Secretary. Under authority of 42 U.S.C. 217a, Section 222 of the Public Health Service Act, as amended, the Department of Health and Human Services established SACGHS to serve as a public forum for deliberations on the broad range of human health and societal issues raised by the development and use of genetic and genomic technologies and, as warranted, to provide advice on these issues. The draft meeting agenda and other information about SACGHS, including information about access to the Web cast, will be available at the following Web site: *http://www4.od.nih.gov/oba/sacghs.htm.* Dated: June 7, 2007. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 07-2964 Filed 6-14-07; 8:45 am]

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