Notices. Notice

7,992 words·~36 min read·/register/2006/02/10/06-1276

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

BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Office of the Chief Science Officer; The Ethics Subcommittee of the Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC), and the Public Health Ethics Committee, Office of the Chief Science Officer, CDC In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), CDC announces the following committee meeting. *Name:* Joint Meeting of the Ethics Subcommittee, ACD, CDC, and CDC's Public Health Ethics Committee. *Time and Date:* 9 a.m.-3:30 p.m., February 16, 2006. *Place:* CDC Global Communications Center (Building 19), 1600 Clifton Road, Atlanta, Georgia 30333. *Status:* Open to the public, limited only by the space available.

The meeting room accommodates approximately 60 people. *Purpose:* The meeting will provide a report on the progress of CDC's efforts to increase the capacity of public health ethics, to manage issues involving public health ethics, and to identify the current and future public health ethics needs and priorities at CDC. *Matters To Be Discussed:* Agenda items will include highlights of public health activities in 2005; public health ethics at CDC in 2006 and the future; a report on the Pandemic Influenza Planning consultation; public health ethics challenges (focus on science); and a discussion on needs, priorities, and action steps.

Agenda items are subject to change as priorities dictate. Due to administrative issues that had to be resolved, the **Federal Register** notice is being published less than fifteen days before the date of the meeting. *Contact Person For More Information:* Jan Devier, Dr.P.H., M.P.A., Health Scientist and Senior Advisor, Science Vision and Alliances Team, Office of the Chief Science Officer, 1600 Clifton Road, NE., M.S. D-50, Atlanta, Georgia 30333. Telephone

(404)639-4690. 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: February 6, 2006. Alvin Hall, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E6-1822 Filed 2-9-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Advisory Committee on Immunization Practices: Meeting 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)announce the following Federal Committee meeting. *Correction:* To include a Vaccines for Children vote on influenza. *Name:* Advisory Committee on Immunization Practices (ACIP). *Times and Dates:* 8 a.m.-6:15 p.m., February 21, 2006. 8 a.m.-5 p.m., February 22, 2006. *Place:* Centers for Disease Control and Prevention, 1600 Clifton Road, NE., Building 19, Room 232, Atlanta, Georgia 30333. *For Further Information Contact:* Demetria Gardner, Epidemiology and Surveillance Division, National Immunization Program, CDC, 1600 Clifton Road, NE., (E-61), Atlanta, Georgia 30333, telephone 404/639-8096, fax 404/639-8616. 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 the CDC and the Agency for Toxic Substances and Disease Registry. Dated: February 6, 2006. Alvin Hall, Director, Management Analysis and Services Office Centers for Disease Control and Prevention. [FR Doc. E6-1823 Filed 2-9-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10167, CMS-10009, CMS-10001, and CMS-10079] Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY: Centers for Medicare & Medicaid Services, HHS. 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

(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:* New collection; *Title of Information Collection:* Competitive Acquisition Program

(CAP)for Medicare Part B Drugs: CAP Physician Election Agreement; *Form Number:* CMS-10167 (OMB#: 0938-NEW); *Use:* Beginning in 2006, physicians will have a choice between acquiring and billing for Part B covered drugs under the Average Sales Price

(ASP)drug payment methodology or electing to receive these drugs from vendors/suppliers selected for the CAP through a competitive bidding process. The provisions for this new payment system are described in the proposed rule (42 CFR Part 414 Subpart K) published March 4, 2005 (70 FR 10746), the interim final rule published July 6, 2005 (70 FR 39022), and a final rule (CMS-1502-FC) that published on November 21, 2005. Competitive bidding is seen as a means of using the dynamics of the marketplace to provide incentives for suppliers to provide reasonably priced products and services of high quality in an efficient manner. The CAP's objectives include the following:

(1)To provide an alternative method for physicians to obtain Part B drugs to administer to Medicare beneficiaries; and

(2)to reduce drug acquisition and billing burdens for physicians.; *Frequency:* Reporting—Annually; *Affected Public:* Business or other-for-profit; *Number of Respondents:* 10,000; *Total Annual Responses:* 10,000; *Total Annual Hours:* 20,000. 2. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* HIPAA Nondiscrimination Provisions (Regulation HCFA 2078-P); *Form Number:* CMS-10009 (OMB#: 0938-819); *Use:* The provisions of Title I of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) are designed to make it easier for people to get access to health care coverage, to reduce the limitations that can be put on the coverage, and to make it more difficult for issuers to terminate the coverage. Title I provisions are divided into group and individual market protections. The group provisions apply to employment-related group health plans and to the issuers who sell insurance in connection with group health plans. Section 2702 of the Public Health Service Act (PHS Act—the HIPAA nondiscrimination provisions) establish rules generally prohibiting group health plans and group health insurance issuers from discriminating against individual participants or beneficiaries based on any health factor of such participants or beneficiaries; *Frequency:* Third party disclosure, Reporting—Annually; *Affected Public:* Business or other-for-profit, Individuals or Households, Not-for-profit institutions, Federal government, and State, Local, or Tribal Government; Number of Respondents: 2600; *Total Annual Responses:* 2600; *Total Annual Hours:* 100. 3. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* HIPAA Nondiscrimination Provisions (Regulation HCFA 2022-IFC); *Form Number:* CMS-10001 (OMB#: 0938-827); *Use:* The provisions of Title I of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) are designed to make it easier for people to access health care coverage; to reduce the limitations that can be put on the coverage; and to make it more difficult for issuers to terminate the coverage. Title I provisions are divided into group and individual market protections. The group provisions apply to employment-related group health plans and to the issuers who sell insurance in connection with group health plans. Section 2702 of the Public Health Service Act (PHS Act) (the HIPAA nondiscrimination provisions) establish rules generally prohibiting group health plans and group health insurance issuers from discriminating against individual participants or beneficiaries based on any health factor of such participants or beneficiaries; *Frequency:* Third party disclosure, Reporting—Annually; *Affected Public:* Business or other-for-profit, Individuals or Households, Not-for-profit institutions, Federal government, and State, Local, or Tribal Government; Number of Respondents: 18; *Total Annual Responses:* 18; *Total Annual Hours:* 194. 4. *Type of Information Collection Request:* Revision of a currently approved collection; *Title of Information Collection:* Hospital Wage Index—Occupational Mix Survey and Supporting Regulations in 42 CFR 412.230, 412.304, and 413.65; *Form Number:* CMS-10079 (OMB#: 0938-0907); *Use:* Section 304 of the Medicare, Medicaid, and State Children's Health Insurance Program (SCHIP) Benefits Improvement and Protection Act of 2000 requires CMS to collect wage data on hospital employees by occupational category, at least once every 3 years in order to construct an occupational mix adjustment to the wage index. CMS first collected occupational mix survey data in 2003 for the FY 2005 wage index. The next data collection is occurring in 2006 for the FY 2008 wage index. In response to industry comments suggesting ways to improve the occupational mix survey, CMS has revised the survey. The purpose of the occupational mix adjustment is to control for the effect of hospitals' employment choices on the wage index. For example, hospitals may choose to employ different combinations of registered nurses, licensed practical nurses, nursing aides, and medical assistants for the purpose of providing nursing care to their patients. The varying labor costs associated with these choices reflect hospital management decisions rather than geographic differences in the costs of labor. Each of the approximately 3,800 acute care hospital inpatient prospective payment system

(IPPS)providers participating in the Medicare program will be required to complete the 2006 Medicare Wage Index Occupational Mix Survey. The initial survey will be forwarded via email to all of CMS's fiscal intermediaries; *Frequency:* Reporting—Other, Triennially; *Affected Public:* Business or other for-profit and Not-for-profit institutions; Number of Respondents: 3,800; *Total Annual Responses:* 3,800; *Total Annual Hours:* 608,000. To obtain copies of the supporting statement and any related forms for these 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 by the OMB Desk Officer at the address below, no later than 5 p.m. on *March 13, 2006* . OMB Human Resources and Housing Branch, Attention: Carolyn Lovett, CMS Desk Officer, New Executive Office Building, Room 10235, Washington, DC 20503. Dated: February 3, 2006. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E6-1819 Filed 2-9-06; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-359, 360, R-55; CMS-368, R-144; and CMS-643] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Centers for Medicare & Medicaid Services, HHS. 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:* Comprehensive Outpatient Rehabilitation Facility

(CORF)Eligibility and Survey Forms and Information Collection Requirements at 42 CFR 485.56, 485.58, 485.60, 485.64, 485.66 and 410.105; *Use:* In order for a provider to participate in the Medicare program as a CORF, a provider must meet the Federal conditions of participation. The form CMS-359 is utilized as an application for facilities wishing to participate in the Medicare/Medicaid program as CORFs. This form initiates the process of obtaining a decision as to whether the conditions of participation are met. The form CMS-360 is an instrument used by the State survey agency to record data collected in order to determine the provider compliance with individual conditions of participation and to report it to the Federal government; *Form Numbers:* CMS-359, 360, R-55 (OMB#: 0938-0267); *Frequency:* Reporting—On occasion; *Affected Public:* State, Local, or Tribal government and Business or other for-profit; *Number of Respondents:* 630; *Total Annual Responses:* 630; *Total Annual Hours:* 300,046. 2. *Type of Information Collection Request:* Revision of a currently approved collection; *Title of Information Collection:* State Medicaid Drug Rebate; *Use:* Section 1927 of the Social Security Act requires each State Medicaid agency to report quarterly prescription drug utilization information to drug manufacturers and to the Centers for Medicare and Medicaid Services. As part of this information, the State Medicaid agencies are required to report the total Medicaid rebate amount they claim they are owed by each drug manufacturer for each covered prescription drug product each quarter; *Form Numbers:* CMS-368, R-144 (OMB#: 0938-0582); *Frequency:* Reporting—Quarterly; *Affected Public:* State, Local, or Tribal government; *Number of Respondents:* 51; *Total Annual Responses:* 204; *Total Annual Hours:* 9,389. 3. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* Hospice Survey and Deficiencies Report Form and Supporting Regulations at 42 CFR 442.30 and 488.26; *Use:* In order to participate in the Medicare program, a hospice must meet certain Federal health and safety conditions of participation. This form is used by State surveyors to record data about a hospice's compliance with these conditions of participation in order to initiate the certification or recertification process; *Form Number:* CMS-643 (OMB#: 0938-0379); *Frequency:* Reporting—Annually; *Affected Public:* Not-for-profit institutions and Business or other for-profit; *Number of Respondents:* 2,293; *Total Annual Responses:* 475; *Total Annual Hours:* 238. 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 April 11, 2006. CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development—A, Attention: Melissa Musotto (CMS-359, 360, R-55; CMS-368, R-144; and CMS-643) Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Dated: January 31, 2006. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E6-1820 Filed 2-9-06; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004D-0369] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use 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 (the PRA). DATES: Fax written comments on the collection of information by March 13, 2006. ADDRESSES: OMB is still experiencing significant delays in the regular mail, including first class and express mail, and messenger deliveries are not being accepted. To ensure that comments on the information collection are received, OMB recommends that comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, Desk Officer for FDA, FAX: 202-395-6974. 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 compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use Since 1992, when FDA issued its Statement of Policy: Foods Derived from New Plant Varieties (57 FR 22984, May 29, 1992), FDA has encouraged developers of new plant varieties, including those varieties that are developed through biotechnology, to consult with FDA early in the development process to discuss possible scientific and regulatory issues that might arise. The current guidance continues to foster early communication by encouraging developers to submit to FDA their evaluation of the food safety of their new protein. Such communication helps to ensure that any potential food safety issues regarding a new protein in a new plant variety are resolved early in development, prior to any possible inadvertent introduction into the food supply of material from that plant variety. FDA believes that any food safety concern related to such material entering the food supply would be limited to the potential that a new protein in food from the plant variety could cause an allergic reaction in susceptible individuals or could be a toxin. This guidance describes the procedures for early food safety evaluation of new proteins in new plant varieties, including bioengineered food plants, and the procedures for communicating with FDA about the safety evaluation. In the **Federal Register** of November 24, 2004 (69 FR 68381), FDA published a notice of availability with a 60-day comment period requesting public comment on the collection of information in FDA's draft guidance document titled, “Guidance for Industry: Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use.” Nonresponsive comments FDA received approximately 5,000 letters in response to the November 24, 2004, notice. However, many of these letters contained comments that were not responsive to the PRA questions. For example, several comments expressed the following opinions: The collection of information was insufficient to ensure safety; the agency might not be able to commit sufficient resources to performing early food safety reviews without having to redirect resources from other tasks; the decision should not be left to the developer regarding when to submit an early food safety evaluation to the agency; and the objectivity and scientific expertise of the individuals reviewing the information may be inadequate. (Response) These comments are general comments directed to the adequacy of the guidance, rather than specific comments relevant to the collection of information; therefore, these non-responsive comments will not be addressed in this document. Responsive comments FDA received several letters with specific comments responsive to the comment request concerning the proposed information collection in the notice. The comments and FDA's responses follow. (Comment 1) Several comments were supportive of the information collection, stating that the information collection was necessary for FDA to fulfill statutory requirements to protect the safety of the food supply. Relevant to the minimization of burden, several of these comments also noted that the information collection was appropriately limited in scope to prevent duplicative submissions among Federal agencies. (Response) These comments provide support for the utility of the information collection and confirm that the collection will not result in a duplicative information collection among Federal agencies. (Comment 2) One comment suggested that FDA should minimize the burden on developers by referencing in the guidance the availability of public protein databases that could be useful in the evaluation of allergen or toxin homology. (Response) FDA does not want to reference or list the various databases because to do so would imply that FDA is endorsing any or all of them. FDA finds that there are several databases in the public domain that are easily obtained through the internet, are known in the scientific community, and are in common use by developers of bioengineered crops. (Comment 3) One comment suggested that FDA could minimize the burden of the proposed collection of information by clarifying that a weight of the evidence approach is applied to the assessment of potential allergenicity of a new protein. The comment further suggested that alternative methods and protocols be considered in the evaluation of the allergenicity of new proteins. (Response) FDA's guidance does not state that a weight of the evidence approach will be applied to the evaluation. The guidance describes a case-by-case evaluation that recognizes that different pieces of information may have varying importance for the food safety evaluation depending on the characteristics of the protein. As stated in the guidance, developers are free to use alternative approaches in their evaluations. The comment fails to explain how a weight of the evidence approach would reduce the burden under the PRA. (Comment 4) One comment suggested as an approach to minimize burden on developers that FDA treat highly similar proteins as a family of proteins, if they differ only by a few amino acids but retain the same function, rather than evaluating each protein individually, though the comment further suggests that certain aspects of a protein may be evaluated individually. (Response) FDA notes that the guidance is intended to consider specific proteins, not protein families. FDA further notes that even small changes in amino acid sequence may alter a protein, and these small differences could also have implications for food safety. However, if there is relevant information contained in a previous submission, that information can be incorporated by reference into a current submission for a new protein evaluation. (Comment 5) One comment suggested as a means of minimizing burden of the proposed collection of information that FDA provide standard forms or formats for certain elements of the submission (e.g., bioinformatics reports). The comment also suggested minimizing burden by making greater use of electronic submissions. (Response) FDA has considered the use of standardized forms or formats and at this time does not believe that their use would reduce the burden of the information collection. The use of standardized forms could discourage alternative approaches for the presentation of data in an evaluation that might more clearly or thoroughly set forth the data. Developers will have access to the forms and formats used by previous submitters and are free to use them; thus, at this time we do not perceive a need for a standardized form. Based on its experience in evaluation of submissions FDA will in the future revisit whether the use of standardized forms and formats would be advantageous to developers. With respect to electronic submissions, FDA states in the guidance that electronic submissions are acceptable, but one paper copy is also requested. Efforts are underway at FDA to convert in the future to a submission process that is entirely electronic. (Comment 6) One comment stated that a way to enhance the quality, utility, and clarity of the information to be collected is to follow guidance available from the Codex Alimentarius. Although the comment did not specify which guidance from the Codex Alimentarius FDA should follow, FDA believes that the comment is referring to the Codex Alimentarius “Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants” (CAC/GL 45-2003) (the Codex Plant Guideline), containing “Annex: Assessment of Possible Allergenicity” (the Codex Allergenicity Annex). The comment also stated that FDA should make Codex guidance a mandatory part of its guidance. (Response) FDA agrees in part and disagrees in part. FDA notes that its recommendations in this guidance are consistent with the approach recommended in the Codex Plant Guideline. In fact, FDA references the Codex Plant Guideline as a resource to be consulted by a developer in evaluating the food safety of a new protein. However, FDA notes that the Codex Plant Guideline addresses a broad range of issues associated with food safety assessment of food derived from bioengineered plants. While FDA's guidance is consistent with the Codex Plant Guideline, it does not address the entire broad range of issues as that document. FDA's guidance is focused on the food safety issues that might arise from the intermittent, low-level presence of material from a plant being developed for food and feed use. FDA believes that any potential risk from the intermittent, low level presence of such material in the food supply would be limited to the food safety of the new proteins. FDA references the Codex Plant Guideline, paragraphs 34-43 under Expressed Substances (non-nucleic acid substances) and the Codex Allergenicity Annex, for that component of the safety review. FDA disagrees with the comment's suggestion that the agency make the Codex Plant Guideline a mandatory part of its guidance. While FDA believes that the Codex Plant Guideline and the Codex Allergenicity Annex are useful documents, it recognizes that other approaches may also be appropriate. (Comment 7) One comment stated that while the information to be collected is essential and important for FDA to obtain, the information is inadequate to fulfill FDA's “stated and mandated goals,” and therefore it is of questionable utility. (Response) FDA disagrees. The guidance is properly focused on the food safety assessment of a new protein produced in a new plant variety when there might be a low level, intermittent presence of material from a plant being developed for food. Although the commenter would like more information to be presented for FDA review at this stage, FDA notes that more information is not necessary because the information that the guidance recommends a developer collect and present to FDA as part of a food safety evaluation of a protein is adequate for the specific assessment that FDA is making at this stage. FDA recommends that a broader scope of information be presented to FDA for review at subsequent evaluation stages. For example, when a developer utilizes the recommendations articulated in FDA's guidance entitled, “Consultation Procedures for New Plant Varieties” (available at *http://www.cfsan.fda.gov/~lrd/consulpr.html* ), FDA expects that significantly more information will be presented during the consultation. (Comment 8) Several comments challenged the accuracy of FDA's estimate of the burden of the proposed collection of information. These comments opined that FDA should collect more extensive information than what is proposed in the guidance, and they concluded, therefore, that FDA had underestimated the burden of the proposed information collection. The comments did not challenge the accuracy of the burden estimate for the information as proposed in the guidance. (Response) FDA notes that the comments did not challenge the accuracy of FDA's estimate, rather they challenged what FDA recommends in the guidance. FDA believes that the estimate of the burden of the proposed collection of information is accurate. 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 First four data components 20 1 20 4 80 Two other data components 20 1 20 16 320 Total 400 1 There are no capital costs or operating and maintenance costs associated with this collection of information. One Time Burden Completing an early food safety evaluation for a new protein from a new plant variety will be a one-time burden (one evaluation per new protein). FDA cannot know how many developers will choose to complete an early food safety evaluation for their new plant protein. Many developers of novel plants may choose not to submit an evaluation because the field testing of a plant containing a new protein is conducted in such a way (e.g., on such a small scale, or in such isolated conditions, etc.) that cross-pollination with traditional crops or commingling of plant material is not likely to be an issue. Also, other developers may have previously communicated with FDA about the food safety of a new plant protein, for example, when the same protein was expressed in a different crop. FDA scientists predict that this draft guidance will generate about 20 to 150 early food safety evaluations yearly. While there is uncertainty as to the number of developers who will choose to submit an evaluation, FDA estimates that the annual number of early food safety evaluations will be closer to the lower bound estimate of 20 evaluations rather than the upper bound estimate of 150 evaluations. This estimation is supported by the fact that on average there have been nine initial biotechnology consultations per year. An initial biotechnology consultation has traditionally been the first discussion between a developer and FDA about a food made from a new bioengineered plant variety; it is usually bioengineered varieties of plants that are the subject of a consultation with FDA. Evaluation Components The early food safety evaluation for new proteins includes six main data components. Four of these data components are easily and quickly obtainable, having to do with the identity and source of the protein. FDA estimates that completing these data components will take about 4 hours per evaluation. In table 1 of this document, row 1 shows that for 20 evaluations, the total burden for these 4 data components is 80 hours. Two data components ask for original data to be generated. One data component consists of a bioinformatics analysis which can be performed using publicly available databases. The other data component involves `wet' lab work to assess the new protein's stability and the resistance of the protein to enzymatic degradation using appropriate in vitro assays (protein digestibility study). The paperwork burden of these two data components consists of the time it takes the company to put together the information on these two data components to submit to FDA. We estimate that these two data components will take 16 hours to complete (8 hours for each component). In Table 1 of this document, row 2 shows that for 20 evaluations, the total burden for these two data components is 320 hours. Dated: February 6, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-1806 Filed 2-9-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N-0296] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Financial Disclosure by Clinical Investigators 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 March 13, 2006. ADDRESSES: OMB is still experiencing significant delays in the regular mail, including first class and express mail, and messenger deliveries are not being accepted. 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: Fumie Yokota, Desk Officer for FDA, FAX: 202-395-6974. FOR FURTHER INFORMATION CONTACT: Karen Nelson, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1482. 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. Financial Disclosure by Clinical Investigators—(OMB Control Number 0910-0396)—Extension Respondents are sponsors of marketing applications that contain clinical data from studies covered by the regulations. These sponsors represent pharmaceutical, biologic and medical device firms. The applicant will incur reporting costs in order to comply with the final rule. Applicants will be required to submit, for example, the complete list of clinical investigators for each covered study, not employed by the applicant and/or sponsor of the covered study, and either certify to the absence of certain financial arrangements with clinical investigators or disclose the nature of those arrangements to FDA and the steps taken by the applicant or sponsor to minimize the potential for bias. The clinical investigator will have to supply information regarding financial interests or payments held in the sponsor of the covered study. FDA has said that it has no preference as to how this information is collected from investigators and that sponsors/applicants have the flexibility to collect the information in the most efficient and least burdensome manner that will be effective. FDA estimated that the total reporting costs of sponsors would be less than $450,000 annually. Costs could also occur after a marketing application is submitted if FDA determines that the financial interests of an investigator raise significant questions about the integrity of the data. FDA estimates the burden of this collection of information as follows: ** Table 1.—Estimated Annual Reporting Burden 1 ** 21 CFR Section No. of Respondents Annual Frequency per Response Total Annual Responses Hours Per Response Total Hours 54.4(a)(1) and (a)(2) 1,000 1 1,000 5 5,000 54.4(a)(3) 100 1 100 20 2,000 54.4 46,000 .25 11,500 .1 11,500 Total 18,500 1 There are no capital cost or operating and maintenance costs associated with this collection of information. The sponsors of covered studies will be required to maintain complete records of compensation agreements with any compensation paid to nonemployee clinical investigators, including information showing any financial interests held by the clinical investigator, for a time period of 2 years after the date of approval of the applications. This time is consistent with the current recordkeeping requirements for other information related to marketing applications for human drugs, biologics, and medical devices. Currently, sponsors of covered studies must maintain many records with regard to clinical investigators, including protocol agreements and investigator resumes or curriculum vitae. FDA estimates than an average of 15 minutes will be required for each recordkeeper to add this record to clinical investigators' file. ** Table 2.—Estimated Annual Recordkeeping Burden 1 ** 21 CFR Section No. of Recordkeepers Annual Frequency per Recordkeeping Total Annual Records Hours Per Recordkeeper Total Hours 54.6 1,000 1 1,000 .25 250 Total 250 1 There are no capital costs or operating and maintenance costs associated with this collection of information. In the **Federal Register** of August 25, 2005 (70 FR 49928), FDA announced the availability of the draft guidance and requested comments for 60 days on the information collection. No comments were received regarding this information collection. Dated: February 6, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-1807 Filed 2-9-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N-0425] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions 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 March 13, 2006. ADDRESSES: OMB is still experiencing significant delays in the regular mail, including first class and express mail, and messenger deliveries are not being accepted. 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: Fumie Yokota, Desk Officer for FDA, FAX: 202-395-6974. 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 compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions—(OMB Control Number 0910-0183)—Extension The Administrative Procedures Act (5 U.S.C. 553(e)), provides that every agency shall give an interested person the right to petition for issuance, amendment, or repeal of a rule. Under part 10 (21 CFR part 10), § 10.30 sets forth the format and procedures by which an interested person may submit to FDA, in accordance with § 10.20 (submission of documents to the Division of Dockets Management (DDM)), a citizen petition requesting the Commissioner of Food and Drugs (the Commissioner) to issue, amend, or revoke a regulation or order, or to take or refrain from taking any other form of administrative action. The Commissioner may grant or deny such a petition, in whole or in part, and may grant such other relief or take other action as the petition warrants. Respondents are individuals or households, State or local governments, not-for-profit institutions, and businesses or other for-profit institutions or groups. Section 10.33, issued under section 701(a) of the Federal, Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 371(a)), sets forth the format and procedures by which an interested person may request reconsideration of part or all of a decision of the Commissioner in a petition submitted under § 10.25 (initiation of administrative proceedings). A petition for reconsideration must contain in a well-organized format a full statement of the factual and legal grounds upon which the petition relies. The grounds must demonstrate that relevant information and views contained in the administrative record were not previously or not adequately considered by the Commissioner. The respondent must submit a petition no later than 30 days after the decision has been made. However, the Commissioner may, for good cause, permit a petition to be filed after 30 days. An interested person who wishes to rely on information or views not included in the administrative record shall submit them with a new petition to modify the decision. FDA uses the information provided in the request to determine whether to grant the petition for reconsideration. Respondents to this collection of information are individuals or households, State or local governments, not-for-profit institutions, and businesses or other for-profit institutions who are requesting a reconsideration of a matter from the Commissioner. Section 10.35, issued under section 701(a) of the act, sets forth the format and procedures by which an interested person may request, in accordance with § 10.20 (submission of documents to DDM), the Commissioner to stay the effective date of any administrative action. Such a petition must provide the following information:

(1)The decision involved;

(2)the action requested, including the length of time for which a stay is requested; and

(3)a statement of the factual and legal grounds on which the interested person relies in seeking the stay. FDA uses the information provided in the request to determine whether to grant the petition for a stay of action. Respondents to this information collection are interested persons who choose to file a petition for an administrative stay of action. Section 10.85, issued under section 701(a) of the act, sets forth the format and procedures by which an interested person may request, in accordance with § 10.20 (submission of documents to the DDM), an advisory opinion from the Commissioner on a matter of general applicability. An advisory opinion represents the formal position of FDA on a matter of general applicability. When making a request, the petitioner must provide a concise statement of the issues and questions on which an opinion is requested, and a full statement of the facts and legal points relevant to the request. Respondents to this collection of information are interested persons seeking an advisory opinion from the Commissioner on the agency's formal position for matters of general applicability. In the **Federal Register** of November 16, 2005 (70 FR 69574), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. ** Table 1.—Estimated Annual Reporting Burden 1 ** 21 CFR Section No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 10.30 156 3 468 12 5,616 10.33 10 2 20 10 200 10.35 13 2 26 10 260 10.85 2 1 2 16 32 Total 6,108 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: February 6, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-1846 Filed 2-9-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005P-0104] Determination That PEPTAVLON (Pentagastrin) for Subcutaneous Injection, 0.25 Milligrams per Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)has determined that PEPTAVLON (pentagastrin) for subcutaneous injection, 0.25 milligrams

(mg)per milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for pentagastrin for subcutaneous injection, 0.25 mg/mL. FOR FURTHER INFORMATION CONTACT: Tawni B. Schwemer, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,301-594-2041. SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA sponsors must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the “listed drug,” which is typically a version of the drug that was previously approved. Sponsors of ANDAs do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). The only clinical data required in an ANDA are data to show that the drug that is the subject of the ANDA is bioequivalent to the listed drug. The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is generally known as the “Orange Book.” Under FDA regulations, drugs are withdrawn from the list if the agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). PEPTAVLON for subcutaneous injection is the subject of approved NDA 17-048 held by Wyeth Ayerst Laboratories (Wyeth Ayerst). PEPTAVLON (pentagastrin) for subcutaneous injection is a testing agent to help diagnose problems or diseases of the stomach. This test determines how much acid a patient's stomach produces. PEPTAVLON for subcutaneous injection, 0.25 mg/mL, was approved on July 26, 1974. Wyeth Ayerst ceased manufacture of PEPTAVLON for subcutaneous injection, 0.25 mg/mL, in March 2002, and requested that FDA withdraw approval of the NDA (68 FR 49481, August 18, 2003). Therefore, it was moved from the “Prescription Drug Product List” to the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. Under 21 CFR 314.161(a)(3), the agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness when a person petitions for such a determination under 21 CFR 10.25(a) and § 10.30 (21 CFR 10.30). Arnall Golden Gregory LLP submitted a citizen petition dated March 7, 2005 (Docket No. 2005P-0104/CP1), under § 10.30, requesting that the agency determine whether PEPTAVLON (pentagastrin) for subcutaneous injection, 0.25 mg/mL, was withdrawn from sale for reasons of safety or effectiveness. After considering the citizen petition and reviewing agency records, FDA has determined that PEPTAVLON for subcutaneous injection, 0.25 mg/mL, approved under NDA 17-048, was not withdrawn from sale for reasons of safety or effectiveness. The petitioner identified no data or other information suggesting that PEPTAVLON (pentagastrin) for subcutaneous injection, 0.25 mg/mL, was withdrawn from sale as a result of safety or effectiveness concerns. FDA's independent evaluation of relevant literature and data has not uncovered anything that would indicate that this product was withdrawn for reasons of safety or effectiveness. Accordingly, the agency will continue to list PEPTAVLON (pentagastrin) for subcutaneous injection, 0.25 mg/mL, in the “Discontinued Drug Product List” section of the Orange Book. ANDAs that refer to PEPTAVLON for subcutaneous injection, 0.25 mg/mL, may be approved by the agency. Dated: February 2, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-1847 Filed 2-9-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HOMELAND SECURITY Coast Guard [CGD08-06-003] Houston/Galveston Navigation Safety Advisory Committee AGENCY: Coast Guard, DHS. ACTION: Notice of meetings. SUMMARY: The Houston/Galveston Navigation Safety Advisory Committee (HOGANSAC) and its working groups will meet to discuss waterway improvements, aids to navigation, area projects impacting safety on the Houston Ship Channel, and various other navigation safety matters in the Galveston Bay area. All meetings will be open to the public. DATES: The next meeting of HOGANSAC will be held on Thursday, February 23, 2006 at 1 p.m. The meeting of the Committee's working groups will be held on Thursday, February 9, 2006 at 9 a.m. The meetings may adjourn early if all business is finished. Members of the public may present written or oral statements at either meeting. Requests to make oral presentations or distribute written materials at the full HOGANSAC meeting should reach the Coast Guard five

(5)working days before that meeting. Requests to have written materials distributed to each member of the full committee in advance of their meeting should reach the Coast Guard at least ten

(10)working days before the full HOGANSAC meeting. ADDRESSES: The full Committee meeting will be held at the Charles P. Doyle Convention Center, 2010 5th Avenue North, Texas City, Texas 77590, (409-948-3111). The working groups meeting will be held at Coast Guard Sector Houston-Galveston, 9640 Clinton Dr. Houston, TX 77029 (713-671-5100). This notice is available on the Internet at *http://dms.dot.gov* . FOR FURTHER INFORMATION CONTACT: Captain Richard Kaser, Executive Director of HOGANSAC, telephone

(713)671-5199, Commander Jerry Torok, Executive Secretary of HOGANSAC, telephone

(713)671-5164, or Lieutenant Junior Grade Kevin Cooper, Assistant to the Executive Secretary of HOGANSAC, telephone

(713)678-9001, e-mail *kcooper@grugalveston.uscg.mil* . Written materials and requests to make presentations should be sent to Commanding Officer, Sector Houston/Galveston, Attn: LTJG Cooper, 9640 Clinton Drive, Houston, TX 77029. SUPPLEMENTARY INFORMATION: Notice of this meeting is given pursuant to the Federal Advisory Committee Act, 5 U.S.C. App. 2. Agendas of the Meetings *Houston/Galveston Navigation Safety Advisory Committee (HOGANSAC).* The tentative agenda includes the following:

(1)Opening remarks by the Committee Sponsor (RADM Duncan) or the Committee Sponsor's representative, Executive Director (CAPT Kaser) and Chairperson (Ms. Patricia Clark).

(2)Approval of the October 18, 2005 minutes.

(3)Old Business:

(a)Dredging projects.

(b)AtoN Knockdown Working Group.

(c)Navigation Operations subcommittee report.

(d)Area Maritime Security Committee Liaison's report.

(e)Technology subcommittee report.

(f)Deep draft Entry Facilitation Working Group.

(g)Port Coordination Team Updates.

(h)Limited Visibility Working Group.

(i)Liquified Natural Gas Working Group.

(4)New Business.

(a)Vessel Traffic Service State of the Waterways Address.

(b)Swearing in of new member.

(c)Other presentations/New business. *Working Groups Meeting.* The tentative agenda for the working groups meeting includes the following:

(1)Presentation by each working group of its accomplishments and plans for the future.

(2)Review and discuss the work completed by each working group. *Procedural* Working groups have been formed to examine the following issues: Dredging and related issues, electronic navigation systems, AtoN knockdowns, impact of passing vessels on moored ships, boater education issues, facilitating deep draft movements and mooring infrastructure. Not all working groups will provide a report at this session. Further, working group reports may not necessarily include discussions on all issues within the particular working group's area of responsibility. All meetings are open to the public. Please note that the meetings may adjourn early if all business is finished. Members of the public may make presentations, oral or written, at either meeting. Requests to make oral presentations or distribute written materials at the full HOGANSAC meeting should reach the Coast Guard five

(5)working days before that meeting. Requests to have written materials distributed to each member of the full committee in advance of their meeting should reach the Coast Guard at least ten

(10)working days before the full HOGANSAC meeting and should include fifteen

(15)copies of the materials. Information on Services for the Handicapped For information on facilities or services for the handicapped or to request special assistance at the meetings, contact the Executive Director, Executive Secretary, or Assistant to the Executive Secretary as soon as possible. Dated: January 27, 2006. R.F. Duncan, Rear Admiral, U.S. Coast Guard, Commander, Eighth Coast Guard District. [FR Doc. 06-1276 Filed 2-7-06; 3:58 pm]

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