Notices. Notice

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BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-06-05CW] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention

(CDC)publishes a list of information collection requests under review by the Office of Management and Budget

(OMB)in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at

(404)639-5960 or send an e-mail to *omb@cdc.gov.* Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to

(202)395-6974. Written comments should be received within 30 days of this notice. Proposed Project Online Surveys to Measure Awareness of Chronic Fatigue Syndrome and the CDC Chronic Fatigue Syndrome Public Awareness Campaign—New—National Center for Health Marketing (NCHM), Centers for Disease Control and Prevention (CDC). Background and Brief Description Chronic fatigue syndrome

(CFS)is a serious illness that affects many Americans. With as many as 900,000 cases, many of which are misdiagnosed or left undiagnosed, the need for a CFS public education and awareness campaign is crucial. Research shows that 80 to 90 percent of patients have not been diagnosed and are not receiving proper medical care. Lack of awareness and information among health care providers about CFS as a serious and treatable illness has created significant barriers to diagnosing and treating those who suffer from CFS. Congress recognized the need to change this scenario, as reported in the Committee Reports for the Senate Appropriations Committee (Senate Report 108-345—To accompany S. 2810 Sept. 15, 2004) when the committee stated: Further, the Committee encourages CDC to better inform the public about this condition, its severity and magnitude and to use heightened awareness to create a registry of CFS patients to aid research in this field. During the next three years, CDC, in partnership with the Chronic Fatigue and Immune Dysfunction Syndrome (CFIDS) Association of America, will build the case that chronic fatigue syndrome should be diagnosed quickly to ensure the best possible health outcomes. To do so, a public education and awareness campaign will be launched to bring about changes in beliefs and social norms among target audiences (women aged 40-60, healthcare practitioners, and the general public) that CFS is a diagnosable and treatable physical illness. Although considerable research will be done to ensure that campaign themes, messages, and materials are effective, there is no way to test the impact of the campaign on the target audience other than to conduct baseline and follow-up surveys. These surveys will measure not only the level of awareness created by the campaign, but will measure change in key knowledge, attitudes and beliefs about CFS among the target audiences. There are no costs to respondents other than their time. The total estimated annualized burden hours are 88. Estimated Annualized Burden Table Type of respondents Form name Number of respondents Number of responses per respondent Average burden/ response (in hours) Consumers (Women, 40-60 years of age) Pre-program survey 133 1 10/60 Consumers (Women, 40-60 years of age) Post-program survey 133 1 10/60 Physician Assistants Pre-program survey 67 1 10/60 Physician Assistants Post-program survey 67 1 10/60 Nurse Practitioners Pre-program survey 67 1 10/60 Nurse Practitioners Post-program survey 67 1 10/60 Dated: February 10, 2006. Betsey Dunaway, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E6-2320 Filed 2-16-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-276] 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:* Prepaid Health Plan Cost Report.; *Use:* Health Maintenance Organizations and Competitive Medical Plans (HMO/CMPs) contracting with the Secretary under Section 1876 of the Social Security Act are required to submit a budget and enrollment forecast, four quarterly reports and a final certified cost report. Health Care Prepayment Plans (HCPPs) contracting with the Secretary under Section 1833 of the Social Security Act are required to submit a budget and enrollment forecast, mid-year report, and final cost report. An HMO/CMP is a health care delivery system that furnishes directly or arranges for the delivery of the full spectrum of health services to an enrolled population. An HCPP is a health care delivery system that furnishes directly or arranges for the delivery of certain physician and diagnostics services up to the full spectrum of non-provider Part B health services to an enrolled population. These reports will be used to establish the reasonable cost of delivering covered services furnished to Medicare enrollees by an HMO/CMP or HCPP.; *Form Numbers:* CMS-276 (OMB#: 0938-0165); *Frequency:* Recordkeeping, Reporting—Quarterly and Annually; *Affected Public:* Business or other for-profit; *Number of Respondents:* 45; *Total Annual Responses:* 225; *Total Annual Hours:* 7,860. 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 18, 2006. 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: February 8, 2006. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E6-2301 Filed 2-16-06; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10062, CMS-10177, and CMS-10044] 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

(MA)program, Part C, and added an outpatient prescription drug benefit, Part D. In accordance with mandates in these laws, the Secretary of the Department of Health and Human Services must implement health status risk adjustment, a payment methodology for Parts C and D that takes into account the health status of plan enrollees. CMS collects inpatient and outpatient data. Part C data is collected using the CMS-HCC (hierarchical condition category) model. Part D data will be collected using the CMS Rx-HCC model. The Rx-HCC model is different from the CMS-HCC model primarily in that it predicts plan liability for drug costs instead of medical/surgical costs for service under Parts A and B. CMS will use the data to make risk adjusted payment under Parts C and D. MA plans, Medicare Advantage Prescription Drug (MA-PD) plans, and stand-alone Prescription Drug Plans (PDP's) will use the data to develop their Parts C and D bids.; *Frequency:* Reporting—Quarterly; *Affected Public:* Business or other-for-profit and not-for-profit institutions; *Number of Respondents:* 505; *Total Annual Responses:* 14,091,370; *Total Annual Hours: 8,351.* 2. *Type of Information Collection Request:* New collection; *Title of Information Collection:* Survey of Contract Labor in Selected Health Industries; *Form Number:* CMS-10177(OMB#: 0938-NEW); *Use:* CMS Medicare reimbursement to hospitals and skilled nursing facilities is based, in part, on the portion of costs which are related to, are influenced by, or vary with the local labor markets. This portion is known as the labor-related share. Currently, contract labor costs for accounting and auditing services, engineering services, legal services, and management consulting services are included in the labor-related share. These costs are calculated based on data published in the Medicare cost reports and the Input-Output tables published by the Bureau of Economic Analysis (BEA). At this time, the labor-related share is not used to reimburse end-stage renal disease centers (ESRDs) for providing Medicare services. However, there is a possibility that this circumstance may change; therefore CMS will include ESRDs in the survey. It is assumed that these professional services contract labor costs are purchased in the local labor market and thus should be included in the labor-related share. A search of the literature reveals no existing work on this subject. Therefore, CMS will survey hospitals, skilled nursing facilities, and kidney dialysis centers to determine if their professional service contract labor is hired from local or national labor markets.; *Frequency:* Reporting—One-time; *Affected Public:* Not-for-profit institutions, Business or other for-profit, Federal Government, State, Local, or Tribal Government; *Number of Respondents:* 4,000; *Total Annual Responses:* 4,000; *Total Annual Hours:* 4,000. 3. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* Medicare Lifestyle Modification Program Demonstration; Form Number: CMS-10044(OMB#: 0938-0871); *Use:* The Medicare Lifestyle Modification Program Demonstration will focus on two Medicare-sponsored, lifestyle modification programs designed to reverse, reduce, or ameliorate the progression of coronary artery disease

(CAD)at risk for significant morbidity and mortality. Lifestyle modification programs are an increasingly important approach to the secondary prevention of coronary morbidity. Research has provided evidence that lifestyle changes decrease cardiovascular risk factors, resulting in lower morbidity and mortality associated with coronary artery disease (CAD). Such programs may reduce the incidence of hospitalizations and invasive procedures among patients with substantial coronary occlusion. Consequently, lifestyle modification may also reduce the need for revascularization procedures (coronary artery bypass graft

(CABG)and percutaneous coronary angioplasty (PTCA)) as well as the use of ambulatory and inpatient services for this disease. This demonstration will test the cost effectiveness and feasibility of providing payment for cardiovascular lifestyle modification program services to Medicare beneficiaries.; *Frequency:* Reporting—Monthly; *Affected Public:* Individuals or Households; *Number of Respondents:* 2,240; *Total Annual Responses: 1,680;* *Total Annual Hours:* 1106. 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 20, 2006. OMB Human Resources and Housing Branch, Attention: Carolyn Lovett, CMS Desk Officer, New Executive Office Building, Room 10235, Washington, DC 20503. Dated: February 9, 2006. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E6-2302 Filed 2-16-06; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N-0393] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Investigational New Drug Regulations 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 20, 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. Investigational New Drug Regulations—(OMB Control Number 0910-0014)—Extension FDA is requesting OMB approval for the reporting and recordkeeping requirements contained in the FDA regulation “Investigational New Drug Application” in part 312 (21 CFR part 312). This regulation implements provisions of section 505(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) to issue regulations under which the clinical investigation of the safety and effectiveness of unapproved new drugs and biological products can be conducted. FDA is charged with implementing statutory requirements that drug products marketed in the United States be shown to be safe and effective, properly manufactured, and properly labeled for their intended uses. Section 505(a) of the act provides that a new drug may not be introduced or delivered for introduction into interstate commerce in the United States unless FDA has previously approved a new drug application (NDA). FDA approves an NDA only if the sponsor of the application first demonstrates that the drug is safe and effective for the conditions prescribed, recommended, or suggested in the product's labeling. Proof must consist, in part, of adequate and well-controlled studies, including studies in humans, that are conducted by qualified experts. The IND regulations establish reporting requirements that include an initial application as well as amendments to that application, reports on significant revisions of clinical investigation plans, and information on a drug's safety or effectiveness. In addition, the sponsor is required to give FDA an annual summary of the previous year's clinical experience. Submissions are reviewed by medical officers and other agency scientific reviewers assigned responsibility for overseeing the specific study. The IND regulations also contain recordkeeping requirements that pertain to the responsibilities of sponsors and investigators. The detail and complexity of these requirements are dictated by the scientific procedures and human subject safeguards that must be followed in the clinical tests of investigational new drugs. The IND information collection requirements provide the means by which FDA can do the following:

(1)Monitor the safety of ongoing clinical investigations;

(2)determine whether the clinical testing of a drug should be authorized;

(3)ensure production of reliable data on the metabolism and pharmacological action of the drug in humans;

(4)obtain timely information on adverse reactions to the drug;

(5)obtain information on side effects associated with increasing doses;

(6)obtain information on the drug's effectiveness;

(7)ensure the design of well-controlled, scientifically valid studies;

(8)obtain other information pertinent to determining whether clinical testing should be continued and information related to the protection of human subjects. Without the information provided by industry in response to the IND regulations, FDA cannot authorize or monitor the clinical investigations which must be conducted prior to authorizing the sale and general use of new drugs. These reports enable FDA to monitor a study's progress, to assure subject safety, to assure that a study will be conducted ethically, and to increase the likelihood that the sponsor will conduct studies that will be useful in determining whether the drug should be marketed and available for use in medical practice. There are two forms that are required under part 312. The first is Form FDA-1571 “Investigational New Drug Application.” A person who intends to conduct a clinical investigation submits this form to FDA. It includes the following information:

(1)A cover sheet containing background information on the sponsor and investigator,

(2)a table of contents,

(3)an introductory statement and general investigational plan,

(4)an investigator's brochure describing the drug substance,

(5)a protocol for each planned study,

(6)chemistry, manufacturing, and control information for each investigation,

(7)pharmacology and toxicology information for each investigation, and

(8)previous human experience with the investigational drug. The second form required under part 312 is Form FDA-1572 “Investigator Statement.” Before permitting an investigator to begin participation in an investigation, the sponsor must obtain and record this form. It includes background information on the investigator and the investigation, and a general outline of the planned investigation and the study protocol. In the **Federal Register** of October 12, 2005 (70 FR 59350), FDA published a 60-day notice requesting public comments on the information collection provisions. No comments were received that pertained to the information collection burden estimates. FDA is requesting OMB approval for the following reporting and recordkeeping requirements in part 312: **Table 1.** REPORTING REQUIREMENTS 21 CFR Section Requirements 312.7(d) Applications for permission to sell an investigational new drug. 312.10(a) Applications for waiver of requirements under part 312. Estimates for this requirement are included under §§ 312.23 and 312.31. 312.20(c) Applications for investigations involving an exception from informed consent under § 50.24 (21 CFR 50.24). Estimates for this requirement are included under § 312.23. 312.23 INDs (content and format). (a)(1) Cover sheet FDA-1571. (a)(2) Table of contents. (a)(3) Investigational plan for each planned study. (a)(5) Investigator's brochure. (a)(6) Protocols—phases 1, 2, and 3. (a)(7) Chemistry, manufacturing, and control information. (a)(7)(iv)( *a* ), (a)(7)(iv)( *b* ), and (a)(7)(iv)( *c* ) A description of the drug substance, a list of all components, and any placebo used. (a)(7)(iv)( *d* ) Labeling: Copies of labels and labeling to be provided each investigator. (a)(7)(iv)( *e* ) Environmental impact analysis regarding drug manufacturing and use. (a)(8) Pharmacological and toxicology information. (a)(9) Previous human experience with the investigational drug. (a)(10) Additional information. (a)(11) Relevant information.

(f)Identification of exception from informed consent. 312.30 Protocol amendments.

(a)New protocol.

(b)Change in protocol.

(c)New investigator.

(d)Content and format.

(e)Frequency. 312.31 Information amendments.

(b)Content and format. Chemistry, toxicology, or technical information. 312.32 Safety reports. (c)(1) Written reports to FDA and to investigators. (c)(2) Telephone reports to FDA for fatal or life-threatening experience. (c)(3) Format or frequency.

(d)Followup submissions. 312.33 Annual reports.

(a)Individual study information.

(b)Summary information. (b)(1) Adverse experiences. (b)(2) Safety report summary. (b)(3) List of fatalities and causes of death. (b)(4) List of discontinuing subjects. (b)(5) Drug action. (b)(6) Preclinical studies and findings. (b)(7) Significant changes.

(c)Next year general investigational plan.

(d)Brochure revision.

(e)Phase I protocol modifications.

(f)Foreign marketing developments. 312.35 Treatment use of investigational new drugs.

(a)Treatment protocol submitted by an investigational new drug sponsor.

(b)Treatment investigational new drug application

(IND)submitted by licensed practitioner. 312.36 Requests for emergency use of an investigational new drug. 312.38(b) and

(c)Notification of withdrawal of an investigational new drug. 312.42(e) Sponsor requests that a clinical hold be removed and submits a complete response to the issues identified in the clinical hold order. 312.44(c) and

(d)Opportunity for sponsor response to FDA when an investigational new drug is terminated. 312.45(a) and

(b)Sponsor request for, or response to, inactive status determination of an investigational new drug. 312.47(b) “End-of-Phase 2” meetings and “Pre-NDA” meetings. 312.53(c) Investigator information. Investigator report (Form FDA-1572) and narrative; Investigator's background information; phase 1 outline of planned investigation; and phase 2 outline of study protocol; financial disclosure information. 312.54(a) and

(b)Sponsor submissions concerning investigations involving an exception from informed consent under § 50.24. 312.55(b) Sponsor reports to investigators on new observations, especially adverse reactions and safe use. Only “new observations” are estimated under this section; investigator brochures are included under § 312.23. 312.56(b), (c), and

(d)Sponsor monitoring of all clinical investigations, investigators, and drug safety; notification to FDA. 312.58(a) Sponsor's submission of records to FDA on request. 312.64 Investigator reports to the sponsor.

(a)Progress reports.

(b)Safety reports

(c)Final reports.

(d)Financial disclosure reports. 312.66 Investigator reports to Institutional Review Board. Estimates for this requirement are included under § 312.53. 312.70(a) Investigator disqualification; opportunity to respond to FDA. 312.83 Sponsor submission of treatment protocol. Estimates for this requirement are included under §§ 312.34 and 312.35. 312.85 Sponsors conducting phase 4 studies. Estimates for this requirement are included under § 312.23 in OMB control number 0910-0014, and §§ 314.50, 314.70, and 314.81 (21 CFR 314.50, 314.70, and 314.81) in OMB control number 0910-0001. 312.110(b) Request to export an investigational drug. 312.120(b) and (c)(2) Sponsor's submission to FDA for use of foreign clinical study to support an IND. Estimates for this requirement are included under §§ 312.23 and 312.30 in OMB control number 0910-0014, and §§ 314.50, 314.60, and 314.70 (21 CFR 314.60) in OMB control number 0910-0001. 312.120(c)(3) Sponsor's report to FDA on findings of independent review committee on foreign clinical study. Estimates for this requirement are included under §§ 312.23 and 312.30 in OMB control number 0910-0014, and §§ 314.50, 314.60, and 314.70 in OMB control number 0910-0001. 312.130(d) Request for disclosable information for investigations involving an exception from informed consent under § 50.24. RECORDKEEPING REQUIREMENTS 21 CFR Section Requirements 312.52(a) Transfer of obligations to a contract research organization. 312.57(a) and

(b)Sponsor recordkeeping. 312.59 Sponsor recordkeeping of disposition of unused supply of drugs. Estimates for this requirement are included under § 312.57. 312.62(a) Investigator recordkeeping of disposition of drugs. 312.62(b) Investigator recordkeeping of case histories of individuals. 312.160(a)(3) Records maintenance: shipment of drugs for investigational use in laboratory research animals or in vitro tests. 312.160(c) Shipper records of alternative disposition of unused drugs. In tables 2 and 3 of this document, the estimates for “No. of Respondents,” “No. of Responses per Respondent,” and “Total Annual Responses” were obtained from the Center for Drug Evaluation and Research

(CDER)and the Center for Biologics Evaluation and Research

(CBER)reports and data management systems for submissions received in 2004 and from other sources familiar with the number of submissions received under part 312. The estimates for “Hours per Response” were made by CDER and CBER individuals familiar with the burden associated with these reports and from estimates received from the pharmaceutical industry. FDA estimates the burden of this collection of information as follows: **Table 2.—Estimated Annual Reporting and Recordkeeping Burden for Human Drugs** 1 REPORTING BURDEN 21 CFR Section No. of Respondents No. of Responses per Respondent Total Annual Responses Hours per Response Total Hours 312.7(d) 9 1.4 13 24 7,488 312.23(a) through

(f)1,245 1.3 1,597 1,600 2,555,200 312.30(a) through

(e)1,257 13.3 16,687 284 4,739,108 312.31(b) 1,116 7.4 8,298 100 829,800 312.32(c) and

(d)649 24.7 16,052 32 513,664 312.33(a) through

(f)1,821 2.5 4,516 360 1,625,760 312.35(a) and

(b)5 1.2 6 300 1,800 312.36 109 1.1 121 16 1,936 312.38(b) and

(d)44 1 45 16 720 312.45(a) and

(b)185 1.5 271 12 3,252 312.47(b) 215 1.7 355 160 56,800 312.53(c) 21,194 1 21,194 80 1,695,520 312.54(a) and

(b)0 0 0 48 0 312.55(b) 807,400 1 807,400 48 38,755,200 312.56(b), (c), and

(d)13 1 13 80 1,040 312.58(a) 88 3.8 340 8 2,720 312.64(a) through

(d)31,791 1 31,791 24 762,984 312.70(a) 4 1 4 40 160 312.110(b) 33 8.3 276 75 20,700 312.130(d) 5 1 5 8 40 Total reporting burden 51,626,369 RECORDKEEPING BURDEN 21 CFR Section No. of Recordkeepers No. of Records per Recordkeeper Total Annual Records Hours per Record Total Hours 312.52(a) 335 1.5 488 2 976 312.57(a) and

(b)335 119.8 40,148 100 4,014,800 312.62(a) 20,074 1 20,074 40 802,960 312.62(b) 200,740 1 200,740 40 8,029,600 312.160(a)(3) 372 1.5 542 .5 271 312.160(c) 372 1.5 542 .5 271 Total recordkeeping burden 12,848,878 Human drugs total burden hours 64,475,247 1 There are no capital costs or operating and maintenance costs associated with this collection of information. **Table 3.—Estimated Annual Reporting and Recordkeeping Burden for Biologics** 1 REPORTING BURDEN 21 CFR Section No. of Respondents No. of Responses per Respondent Total Annual Responses Hours per Response Total Hours 312.7(d) 41 1.4 58 24 1,392 312.23(a) through

(f)and 312.120(b), (c)(2), and (c)(3) 433 1.3 557 1,808 1,007,056 312.30(a) through

(e)590 6.8 4,014 284 1,139,976 312.31(b) 263 29.3 7,700 100 770,000 312.32(c) and

(d)and 312.56(c) 294 13.7 4,042 32 129,344 312.33(a) through

(f)and 312.56(c) 647 2.3 1,473 360 530,280 312.35(a) and

(b)1 1 1 300 300 312.36 6 1 6 16 96 312.38(b) and

(d)17 1.1 18 16 288 312.45(a) and

(b)60 1.8 107 12 1,284 312.47(b) 43 1.5 66 160 10,560 312.53(c) 348 6.6 2,303 80 184,240 312.54(a) and

(b)1 1 1 48 48 312.55(b) 138 2.5 347 48 16,656 312.56(b) and

(d)14 1.6 23 80 1,840 312.58(a) 8 1 8 8 64 312.64(a) through

(d)6,003 3.5 21,185 24 508,440 312.70(a) 6 1 6 40 240 312.110(b) 21 1 21 75 1,575 312.130(d) 1 1 1 8 8 Total reporting burden 4,338,643 RECORDKEEPING BURDEN 21 CFR Section No. of Recordkeepers Annual Frequency per Recordkeeping Total Annual Records Hours per Record Total Hours 312.52(a) 139 1.4 200 2 400 312.57(a) and

(b)433 2.6 1,114 100 111,400 312.62(a) 5,570 1 5,570 40 222,800 312.62(b) 5,570 10 55,700 40 2,228,000 312.160(a)(3) 146 1.4 211 0.5 105.5 312.160(c) 146 1.4 211 0.5 105.5 Total recordkeeping burden 2,562,811 Total biologics burden hours 6,901,454 1 There are no capital costs or operating and maintenance costs associated with this collection of information. **Table 4.—Estimated Annual Reporting and Recordkeeping Burden for Human Drugs and Biologics** 1 Total human drugs burden hours 64,475,247 Total biologics burden hours 6,901,454 Total burden hours 71,376,701 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: February 9, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-2289 Filed 2-16-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005E-0254] Determination of Regulatory Review Period for Purposes of Patent Extension; ERBITUX AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)has determined the regulatory review period for ERBITUX and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human biological product. ADDRESSES: Submit written or electronic comments and petitions to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . FOR FURTHER INFORMATION CONTACT: Claudia V. Grillo, Office of Regulatory Policy (HFD-013), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 240-453-6681. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA recently approved for marketing the human biological product ERBITUX (cetuximab). ERBITUX, used in combination with irinotecan, is indicated for the treatment of epidermal growth factor receptor (EGFR)-expressing metastatic colorectal carcinoma in patients who are refractory to irinotecan-based chemotherapy. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for ERBITUX (U.S. Patent No. 6,217,866) from Aventis Pharmaceuticals, and the Patent and Trademark Office requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated July 8, 2005, FDA advised the Patent and Trademark Office that this human biological product had undergone a regulatory review period and that the approval of ERBITUX represented the first permitted commercial marketing or use of the product. Shortly thereafter, the Patent and Trademark Office requested that FDA determine the product's regulatory review period. FDA has determined that the applicable regulatory review period for ERBITUX is 3,375 days. Of this time, 3,192 days occurred during the testing phase of the regulatory review period, while 183 days occurred during the approval phase. These periods of time were derived from the following dates: 1. *The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective* : November 18, 1994. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on November 18, 1994. 2. *The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C. 262)* : August 14, 2003. The applicant claims August 12, 2003, as the date the product license application

(BLA)for ERBITUX (BLA 125084) was initially submitted. However, FDA records indicate that BLA 125084 was submitted on August 14, 2003. 3. *The date the application was approved* : February 12, 2004. FDA has verified the applicant's claim that BLA 125084 was approved on February 12, 2004. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 391 days of patent term extension. Anyone with knowledge that any of the dates as published is incorrect may submit to the Division of Dockets Management (see ADDRESSES ) written comments and ask for a redetermination by April 18, 2006. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by August 16, 2006. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Comments and petitions should be submitted to the Division of Dockets Management. Three copies of any mailed information are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments and petitions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: Janury 5, 2006. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E6-2354 Filed 2-16-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004D-0283] Guidance for Industry on Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of a guidance for industry (#171) entitled “Waivers of *In Vivo* Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles.” This guidance describes the procedures that the agency recommends for the review of requests for waiver of in vivo demonstration of bioequivalence for generic soluble powder oral dosage form products and Type A medicated articles. DATES: Submit written or electronic comments on agency guidances at any time. ADDRESSES: Submit written comments on this guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments on the guidance via the Internet at *http://www.fda.gov/dockets/ecomments* . Comments should be identified with the full title of the guidance and the docket number found in brackets in the heading of this document. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit written requests for single copies of the guidance to the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your requests. FOR FURTHER INFORMATION CONTACT: Marilyn Martinez, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7577, e-mail: *marilyn.martinez@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: I. Background In the **Federal Register** of August 3, 2004 (69 FR 46553), FDA published a notice of availability for a draft guidance document entitled “Draft Guidance for Industry: Waivers of *In Vivo* Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles” giving interested persons until October 18, 2004, to submit comments on the draft guidance and until October 4, 2004, to comment on the information collection. FDA considered all comments received and, where appropriate, made changes in the guidance. The final guidance differs from the draft guidance in the following ways:

(1)The relationship between granting or denying a waiver based on a demonstration of bioequivalence and granting or denying a generic approval based on the safety of a biomass Type A article has been clarified;

(2)the nature of the information needed to support, and the applicability of, the “Comparison of Formulations” approach described in the guidance has been clarified;

(3)the title of table 1 of the guidance has been clarified;

(4)one value in table 2 of the guidance has been updated; and

(5)other relatively minor editing has been done to clarify the substance of the document. There were no comments directed specifically at the collection of information. II. Significance of Guidance This level 1 guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). This guidance represents the agency's current thinking on the topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternate method may be used as long as it satisfies the requirements of applicable statutes and regulations. III. Paperwork Reduction Act of 1995 FDA is announcing that a collection of information entitled “Guidance for Industry: Waivers of *In Vivo* Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles” has been approved by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995. In the **Federal Register** of October 24, 2005 (70 FR 61451), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. According to the Paperwork Reduction Act of 1995, a collection of information should display a valid OMB control number. The valid OMB control number for this collection of information is 0910-0575. It expires on January 31, 2009. A copy of the supporting statement is available on the Internet at *http://www.fda.gov/ohrms/dockets* . IV. Comments As with all FDA's guidances, the public is encouraged to submit written or electronic comments with new data or other new information pertinent to this guidance. FDA periodically will review the comments in the docket, and where appropriate, will amend the guidance. The agency will notify the public of any such amendments through a notice in the **Federal Register** . Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments at any time. Submit a single copy of electronic comments or two paper copies of any comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. A copy of the document and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. V. Electronic Access Copies of the guidance document entitled “Waivers of *In Vivo* Demonstration of Bioequivalence of Certain Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles” may be obtained from the Center for Veterinary Medicine's Home Page at *http://www.fda.gov/cvm* and from the Division of Dockets Management Web site at *http://www.fda.gov/ohrms/dockets/default.htm* . Dated: February 10, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-2291 Filed 2-16-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006D-0066] Draft Guidance for Industry and FDA Staff: Whole Grains Label Statements; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of a document entitled “Guidance for Industry and FDA Staff: Whole Grain Label Statements.” The draft guidance is intended to provide guidance to industry about what the agency considers to be “whole grain” and to assist manufacturers in labeling their products. DATES: Submit written or electronic comments concerning the draft guidance by April 18, 2006, to ensure their adequate consideration in preparation of the final guidance. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the draft guidance document to the Office of Nutritional Products, Labeling, and Dietary Supplements (HFS-800), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Include a self-addressed adhesive label to assist that office in processing your request. Submit written comments on the draft guidance, to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . To ensure more timely processing of comments, FDA is no longer accepting comments submitted to the agency by e-mail. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Shellee Anderson, Center for Food Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1491, e-mail: *shellee.anderson@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: I. Background Through the years, the Federal Government has worked to provide consistent and scientifically sound recommendations to consumers about healthy eating patterns and wise food choices. Such advice originated with the “Basic Four” and has progressed through today's “Dietary Guidelines for Americans” (developed jointly by the U.S. Department of Health and Human Services and the U.S. Department of Agriculture). “Dietary Guidelines for Americans, 2005” (2005 DG) recommends that Americans, among other things, “consume 3 or more ounce-equivalents of whole grain products per day, with the rest of the recommended grains coming from enriched or whole-grain products” and that “in general at least half the grains should come from whole grains” (Ref. 1). Manufacturers may make factual statements about whole grains on the label of their products, such as “100% whole grain” (as percentage labeling under 21 CFR 102.5(b)) or “10 grams of whole grains” (21 CFR 101.13(i) (3)) provided that the statements are not false or misleading under section 403(a) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 343(a)) and do not imply a particular level of the ingredient, i.e., “high” or “excellent source.” In addition, manufacturers may use health claims relating whole grains to a reduced risk of coronary heart disease and certain cancers on their product labels for qualifying foods based on notifications FDA received under section 403(r)

(C)of the act (21 U.S.C. 343(r)(3)(C)) (health claims based on an authoritative statement of a scientific body) (see *http://www.cfsan.fda.gov/~dms/labfdama.html* ). To assist manufacturers in labeling their products, the agency has reviewed various industry and scientific definitions of “whole grains” and developed guidance to industry about what the agency considers to be “whole grain.” The agency has adopted good guidance practices

(GGPs)that set forth the agency's policies and procedures for the development, issuance, and use of guidance documents (21 CFR 10.115). This draft guidance is being issued as a Level 1 guidance document consistent with the GGPs. The draft guidance represents the agency's current thinking on the topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You may use an alternative approach if such approach satisfies the requirements of applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance (see FOR FURTHER INFORMATION CONTACT ). II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. If you base your comments on scientific evidence or data, please submit copies of the specific information along with your comments. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. III. Electronic Access Persons with access to the Internet may obtain the draft guidance at: *http://www.cfsan.fda.gov/guidance.html* . IV. References The following reference has been placed on display in the Division of Dockets Management (see ADDRESSES ) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. 1. U.S. Department of Health and Human Services and U.S. Department of Agriculture, “Dietary Guidelines for Americans, 2005,” *http://www.healthierus.gov/dietaryguidelines* , 2005. Dated: February 14, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 06-1509 Filed 2-15-06; 8:45 am]

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