Notices. Notice

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

BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-P-0015A and CMS-10204] 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

(MCBS)is a continuous, multipurpose survey of a nationally representative sample of aged, disabled, and institutionalized Medicare beneficiaries. MCBS, which is sponsored by the Centers for Medicare & Medicaid Services, is the only comprehensive source of information on the health status, health care use and expenditures, health insurance coverage, and socioeconomic and demographic characteristics of the entire spectrum of Medicare beneficiaries. MCBS data users can assess the impact of major policy innovations and health care reform on Medicare beneficiaries. They can monitor delivery of services, sources of payment for Medicare covered and non-covered services, beneficiary cost sharing and financial protection, and satisfaction with and the access to health care services. *Form Number:* CMS-P-0015A (OMB#: 0938-0568); *Frequency:* Third Party Disclosure, Recordkeeping, and Reporting—Yearly; *Affected Public:* Individuals or households, Business or other for-profit and not-for-profit institutions; *Number of Respondents:* 16,500; *Total Annual Responses:* 49,500; *Total Annual Hours:* 50,325. 2. *Type of Information Collection Request:* New collection; *Title of Information Collection:* Evaluation of the Medical Adult Day-Care Services Demonstration, Phase I; *Use:* This request seeks Office of Management and Budget's

(OMB)approval of

(1)collection of enrollment data by demonstration sites and

(2)face-to-face interviews with Medicare beneficiaries (not to exceed 45 minutes in length). These data collection and interviews are to be completed during Phase I of the Evaluation of the Medical Adult Day-Care Services Demonstration (Contract Number 500-00-0038/5). Section 703 of the Medicare Prescription Drug, Improvement and Modernization Act of 2003

(MMA)(Pub. L. 108-173) authorizes a three-year demonstration to assess the clinical and cost-effectiveness of providing medical adult day-care services as a substitute for a portion of home health services that would otherwise be provided in the beneficiary's home. Under this authority, the Centers for Medicare & Medicaid Services (CMS), through its Office of Research, Development and Information (ORDI), is conducting the Medical Adult Day-Care Services Demonstration. Five Medicare certified home health agencies were selected by CMS through a competitive process to participate in the demonstration. These five demonstration sites are Aurora Visiting Nurse Association (Milwaukee, Wisconsin), Doctor's Care Home Health (McAllen, Texas), Landmark Home Health Care Services (Allison Park, Pennsylvania), Metropolitan Jewish Health System (Brooklyn, New York) and Neighborly Care Network (St. Petersburg, Florida). *Form Number:* CMS-10204 (OMB#: 0938-NEW); *Frequency:* Reporting—One-time; *Affected Public:* Individuals and Households, Business or other for-profit and Not-for-profit institutions; *Number of Respondents:* 55; *Total Annual Responses:* 110; *Total Annual Hours:* 297.5. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS Web site address at *http://www.cms.hhs.gov/PaperworkReductionActof1995* , or e-mail your request, including your address, phone number, OMB number, and CMS document identifier, to *Paperwork@cms.hhs.gov* , or call the Reports Clearance Office on

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

(202)395-6974. Dated: January 26, 2007. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E7-1685 Filed 2-1-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10079 and CMS-R-245] 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:* Revision of a currently approved collection; *Title of Information Collection:* Hospital Wage Index Occupational Mix Survey and Supporting Regulations in 42 CFR 412.64; *Use:* Section 304(c) of Public Law 106-554 mandates an occupational mix adjustment to the wage index, requiring the collection of data every 3 years on the occupational mix of employees for each short-term, acute care hospital participating in the Medicare program. The 2007/2008 revised survey will provide for the collection of hospital-specific wages and hours data for a 1-year prospective reporting period (July 1, 2007 through June 30, 2008), additional clarifications to the survey instructions, the elimination of the RN subcategories, some refinements to the definitions for the occupational categories, and the inclusion of additional cost centers that typically provide nursing services. The 2007/2008 Medicare occupational mix survey will be applied beginning with the FY 2010 wage index. Each of the approximately 3,600 inpatient prospective payment system providers participating in the Medicare program will be required to complete the revised Medicare Wage Index Occupational Mix Survey. The revised survey will be forwarded to hospitals through CMS's fiscal intermediaries and will be made available on CMS's Web site. *Form Number:* CMS-10079 (OMB#: 0938-0907); *Frequency:* Reporting: Yearly, Biennially and Occasionally; *Affected Public:* Business or other for-profit and Not-for-profit institutions; *Number of Respondents:* 3,600; *Total Annual Responses:* 3,600; *Total Annual Hours:* 1,728,000. 2. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* Medicare and Medicaid Programs OASIS Collection Requirements as Part of the Conditions of Participation for Home Health Agencies and Supporting Regulations in 42 CFR 484.55, 484.205, 484.245, 484.250; *Use:* The Outcome and Assessment Information Set (OASIS) is a requirement for one of the Conditions of Participation

(CoPs)that Home Health Agencies

(HHAs)must meet in order to participate in the Medicare program. Specifically, the CoP at § 484.55 requires that each patient receive from an HHA a patient-specific, comprehensive assessment that identifies a patient's continuing need for home care and meets the patient's medical, nursing, rehabilitative, social and discharge planning needs. In addition, the regulation requires that as part of the comprehensive assessment, HHAs use a standard core assessment data set, the OASIS, to evaluate non-maternity patients. The data collected using OASIS is used for three main purposes: Assessing and improving the quality of care provided by an HHA, submitting and paying claims for Medicare home health services, and surveying the HHAs in accordance with Section 1891 of the Social Security Act (the Act). *Frequency:* Recordkeeping and Reporting—upon patient assessment; *Affected Public:* Business or other for-profit and Not-for-profit institutions; *Number of Respondents:* 8,277; *Total Annual Responses:* 10,105,827; *Total Annual Hours:* 11,977,601. 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 3, 2007. CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development—C, Attention: Bonnie L Harkless, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Dated: January 26, 2007. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E7-1686 Filed 2-1-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0036] Agency Emergency Processing Under Office of Management and Budget Review; Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products; Labeling Comprehension Study AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

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

(OMB)for emergency processing under the Paperwork Reduction Act of 1995 (the PRA). The proposed collection of information concerns an experimental study to test labeling statement alternatives for certain prescription and over-the-counter

(OTC)drug product labeling. DATES: Fax written comments on the collection of information by March 5, 2007. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1482. SUPPLEMENTARY INFORMATION: FDA has requested emergency processing of this proposed collection of information under section 3507(j) of the PRA (44 U.S.C. 3507(j)) and 5 CFR 1320.13. This information is needed prior to the expiration of the normal time periods for OMB clearance under the PRA regulations (5 CFR part 1320) and is essential to the agency's mission to protect the public health and safety. Section 17 of the Best Pharmaceuticals for Children Act (the BPCA) (Public Law 107-109) requires FDA to issue a final rule mandating the addition of a statement to the labeling of each drug product for which an application is approved under section 505 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355). Under the BPCA, the labeling statement is required to include:

(1)A toll-free number for consumers to use to report drug product side effects and

(2)a statement that the number is to be used only for reporting side effects and is not intended to seek or obtain medical advice (the side effects statement). The use of normal clearance procedures would further delay FDA's issuance of a final rule to comply with this congressional mandate. With respect to the following collection of information, FDA invites comments on these topics:

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

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

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

(4)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products; Labeling Comprehension Study On April 22, 2004 (69 FR 21778), FDA published a proposed rule with a proposed side effects statement for certain prescription drug product labeling and a proposed side effects statement for certain OTC drug product labeling. In the proposed rule, FDA solicited comments on the wording of these side effects statements. We received 12 comments suggesting changes to the specific wording of the proposed side effects statements. We also received several comments suggesting that FDA engage in research to study consumer comprehension of the wording of the proposed side effects statements. Among the reasons cited for testing the statements were:

(1)To determine the best and most precise wording for the statements,

(2)to evaluate consumer comprehension of the proposed statements, and

(3)to address concerns that consumers who read the statement will mistakenly call FDA in search of medical advice. In addition, during the clearance process for the proposed rule, both the Office of Information and Regulatory Affairs of OMB and the Office of the Assistant Secretary for Planning and Evaluation of the Department of Health and Human Services suggested that FDA conduct consumer studies on the wording of the side effects statements. After the publication of the proposed rule and based on the comments received, FDA decided to conduct research to study the wording of the proposed side effects statements before issuing a final rule. FDA conducted two focus groups (OMB Control No. 0910-0497) to narrow the field of potential statement alternatives. Based on the findings from the focus groups, FDA has selected several statements for quantitative testing in an experimental study of consumer comprehension. The experimental study will test several ways of stating the required information for maximum comprehension of factual information and necessary action. The experimental study will provide quantitative data to inform FDA's selection of the side effects statements to fulfill the requirements of the BPCA. Each participant will be exposed to only one side effects statement, in a “between-subjects” or “monadic” design. Participants initially will see one statement in the context of either a prescription drug bottle or an OTC Drug Facts label, depending on which condition they are in, and will all answer the same series of questions. For the remainder of the study, each participant will see the statement as they answer questions specifically about the statement. The experimental study data will be collected via the Internet from members of a consumer panel maintained by an external research organization. Panel members are recruited by a variety of means designed to reflect all segments of the population. They are required to have a computer with Internet access. Studies begin with an e-mailed invitation to the sampled respondents. Each panel member has provided demographic data for their household that allows for the selection of samples that resemble closely the distribution of the U.S. population on age, gender, education, and race/ethnicity. A participant recruitment questionnaire (screener) will be used to ensure recruitment criteria are met. Conventional statistical techniques for experimental data (such as descriptive statistics, analysis of variance, and regression models) will be used to analyze the data. This proposed data collection will be one-time only. No successive related data collections are planned. Testing the statements experimentally will provide valuable information on the comprehension, usefulness, and selection of the side effect statements to be included in the final rule. FDA estimates the burden of this collection of information as follows: ** Table 1.—Estimated Annual Reporting Burden 1 ** Activity No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours Administration of Participant Screener 1,684 1 1,684 0.01 17 Administration of Participant Questionnaire 1,600 1 1,600 0.15 240 Total 257 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: January 26, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-1674 Filed 2-1-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0430] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, Postmarketing Studies Status Reports, and Forms FDA 456h and 2567 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 5, 2007. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief Information Officer (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 Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, Postmarketing Studies Status Reports, and Forms FDA 456h and 2567—(OMB Control Number 0910-0338)—Extension Under section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262), manufacturers of biological products must submit a license application for FDA review and approval before marketing a biological product in interstate commerce. Licenses may be issued only upon showing that the establishment and the products for which a license is desired meets standards prescribed in regulations designed to ensure the continued safety, purity, and potency of such products. All such licenses are issued, suspended, and revoked as prescribed by regulations in part 601 (21 CFR part 601). Section 130(a) of the Food and Drug Administration Modernization Act (Public Law 105-115) amended the Federal Food, Drug, and Cosmetic Act (the act) by adding a new provision (section 506B of the act (21 U.S.C. 356b)) requiring reports of postmarketing studies for approved human drugs and licensed biological products. Section 506B of the act provides FDA with additional authority to monitor the progress of postmarketing studies that applicants have made a commitment to conduct and requires the agency to make publicly available information that pertains to the status of these studies. Under section 506B(a) of the act, applicants that have committed to conducting a postmarketing study for an approved human drug or licensed biological product must submit to FDA a status report of the progress of the study or the reasons for the failure of the applicant to conduct the study. This report must be submitted within 1 year after the U.S. approval of the application and then annually until the study is completed or terminated. Section 601.2(a) requires a manufacturer of a biological product to submit an application with accompanying information, including labeling information, to FDA for approval to market a product in interstate commerce. The container and package labeling requirements are provided under §§ 610.60, 610.61, and 610.62 (21 CFR part 610). The estimate for these regulations is included in the estimate under § 601.2(a) in table 1 of this document. Section 601.5(a) requires a licensee to submit to FDA notice of its intention to discontinue manufacture of a product or all products. Section 601.6(a) requires the licensee to notify selling agents and distributors upon suspension of its license, and provide FDA of such notification. Section 601.12(a)(2) requires, generally, that the holder of an approved BLA must assess the effects of a manufacturing change before distributing a biological product made with the change. Section 601.12(a)(4) requires, generally, that the applicant must promptly review all promotional labeling and advertising to make it consistent with any labeling changes implemented. Section 601.12(a)(5) requires the applicant to include a list of all changes contained in the supplement or annual report; for supplements, this list must be provided in the cover letter. The burden estimates for § 601.12(a)(2) are included in the estimates for supplements (§ 601.12(b) and (c)) and annual reports (§ 601.12(d)). The burden estimates for § 601.12(a)(4) are included in the estimates under 601.12(f)(4) (Form FDA 2567) in table 1 of this document or OMB control number 0910-0001 (expires May 31, 2008) since the required information can also be submitted with Form FDA 2253. Section 601.12(b)(1) and (b)(3), (c)(1) and (c)(3), (c)(5), and (d)(1) and (d)(3) require applicants to follow specific procedures to inform FDA of each change, in the product, production process, quality controls, equipment, facilities, responsible personnel or labeling established in an approved license application. The appropriate procedure depends on the potential for the change to have a substantial, moderate, or minimal adverse effect on the identity, strength, quality, purity, or potency of the products as they may relate to the safety or effectiveness of the product. Under § 601.12(b)(4), an applicant may ask FDA to expedite its review of a supplement for public health reasons or if a delay in making the change described in it would impose an extraordinary hardship of the applicant. The burden estimate for § 601.12(b)(4) is minimal and included in the estimate under § 601.12(b)(1) and (b)(3) in table 1 of this document. Section 601.12(e) requires applicants to submit a protocol, or change to a protocol, as a supplement requiring FDA approval before distributing the product. Section 601.12(f)(1), (f)(2), and (f)(3) requires applicants to follow specific procedures to report labeling changes to FDA. Section 601.12(f)(4) requires applicants to report to FDA advertising and promotional labeling and any changes. Under § 601.14, the content of labeling required in § 201.100(d)(3) (21 CFR 201.100(d)(3)) must be in electronic format and in a form that FDA can process, review, and archive. This requirement is in addition to the provisions of §§ 601.2(a) and 601.12(f). The burden estimate for § 601.14 is minimal and included in the estimate under § 601.2(a)

(BLAs)and 601.12(f)(1), (f)(2), and (f)(3) (supplements and annual reports) in table 1 of this document. Section 601.45 requires applicants of biological products for serious or life-threatening illnesses to submit to the agency for consideration, during the pre-approval review period, copies of all promotional materials, including promotional labeling as well as advertisements. In addition to §§ 601.2 and 601.12, there are other regulations in parts 640, 660, and 680 (21 CFR parts 640, 660, and 680) that relate to information to be submitted in a license application or supplement for certain blood or allergenic products: §§ 640.6, 640.17, 640.21(c), 640.22(c), 640.25(c), 640.56(c), 640.64(c), 640.74(a) and (b)(2), 660.51(a)(4), 680.1(b)(2)(iii), and 680.1(d). In table 1 of this document, the burden associated with the information collection requirements in these regulations is included in the burden estimate for § 601.2 and/or § 601.12. A regulation may be listed under more than one section of § 601.12 due to the type of category under which a change to an approved application may be submitted. There are also additional container and/or package labeling requirements for certain licensed biological products: § 640.70(a) for Source Plasma; § 640.74(b)(3) and (b)(4) for Source Plasma Liquid; § 640.84(a) and

(c)for Albumin; § 640.94(a) for Plasma Protein Fraction; § 660.2(c) for Antibody to Hepatitis B Surface Antigen; § 660.28(a) and

(b)for Blood Grouping Reagent; § 660.35(a), (c through g), and (i through m) for Reagent Red Blood Cells; § 660.45 for Hepatitis B Surface Antigen; and § 660.55(a) and

(b)for Anti-Human Globulin. The burden associated with the additional labeling requirements for submission of a license application for these certain biological products is minimal because the majority of the burden is associated with the requirements under § 610.60 through § 610.62 or § 809.10 (21 CFR 809.10). Therefore, the burden estimates for these regulations are included in the estimate under § 610.60 through § 610.62 in table 1 of this document. The burden estimates associated with § 809.10 are approved under OMB control number 0910-0485 (expires June 30, 2008). Section 601.25(b) requests interested persons to submit, for review and evaluation by an advisory review panel, published and unpublished data and information pertinent to a designated category of biological products that have been licensed prior to July 1, 1972. Section 601.26(f) requests that licensees submit to FDA a written statement intended to show that studies adequate and appropriate to resolve questions raised about a biological product have been undertaken for a product if designated as requiring further study under the reclassification procedures. Under § 601.25(b)(3), FDA estimates no burden for this regulation since all requested data and information had been submitted by 1974. Under § 601.26(f), FDA estimates no burden for this regulation since there are no products designated to require further study and none are predicted in the future. However, based on the possible reclassification of a product, the labeling for the product may need to be revised, or a manufacturer, on its own initiative, may deem it necessary for further study. As a result, any changes to product labeling would be reported under § 601.12. Section 601.27(a) requires that applications for new biological products contain data that are adequate to assess the safety and effectiveness of the biological product for the claimed indications in pediatric subpopulations, and to support dosing and administration information. Section 601.27(b) provides that an applicant may request a deferred submission of some or all assessments of safety and effectiveness required under § 601.27(a). Section 601.27(c) provides that an applicant may request a full or partial waiver of the requirements under § 601.27(a). The burden estimates for § 601.27(a) are included in the burden estimate under § 601.2(a) in table 1 of this document, since these regulations deal with information to be provided in an application. Section 601.28 requires sponsors of licensed biological products to submit the information in § 601.28(a), (b), and

(c)to the Center for Biologics Evaluation and Research

(CBER)or the Center for Drug Evaluation and Research

(CDER)each year, within 60 days of the anniversary date of approval of the license. Section 601.28(a) requires sponsors to submit to FDA a brief summary stating whether labeling supplements for pediatric use have been submitted and whether new studies in the pediatric population to support appropriate labeling for the pediatric population have been initiated. Section 601.28(b) requires sponsors to submit to FDA an analysis of available safety and efficacy data in the pediatric population and changes proposed in the labeling based on this information. Section 601.28(c) requires sponsors to submit to FDA a statement on the current status of any postmarketing studies in the pediatric population performed by, or on behalf of, the applicant. If the postmarketing studies were required or agreed to, the status of these studies is to be reported under § 601.70, rather than under this section. Sections 601.33 through 601.35 clarify the information to be submitted in an application to FDA to evaluate the safety and effectiveness of in vivo radiopharmaceuticals. The burden estimates for §§ 601.33 through 601.35 are included in the burden estimate under § 601.2(a) in table 1 of this document, since these regulations deal with information to be provided in an application. Section 601.70(b) requires each applicant of a licensed biological product to submit annually a report to FDA on the status of postmarketing studies for each approved product application. Each annual postmarketing status report must be accompanied by a completed transmittal Form FDA 2252 (approved under OMB control number 0910-0001). Under § 601.70(d), two copies of the annual report shall be submitted to FDA. Section 601.91(b)(2)(iii) requires, in certain circumstances, postmarketing restrictions as needed to ensure the safe use of the biological products distribution conditioned on specified recordkeeping requirements. Section 601.91(b)(3) requires applicants to prepare and provide labeling with relevant information to patient or potential patient for biological products approved under the subpart when human efficacy studies are not ethical or feasible (or based on evidence of effectiveness from studies in animals). Section 601.93 provides that biological products approved under this subpart are subject to the postmarketing recordkeeping and safety reporting applicable to all approved biological products. Section 601.94 requires applicants under this subpart to submit to the agency for consideration during preapproval review period copies of all promotional materials including promotional labeling as well as advertisements. Under § 601.93, any potential postmarketing reports and/or recordkeeping burdens would be included under the adverse experience reporting

(AER)requirements under 21 CFR part 600 (OMB control number 0910-0308; expires May 31, 2005). Therefore, any burdens associated with these requirements would be reported under the AER information collection requirements (OMB control number 0910-0308). Section 610.11(g)(2) provides that a manufacturer of certain biological products may request an exemption from the general safety test

(GST)requirements contained in this subpart. Under § 610.11(g)(2), FDA requires only those manufacturers of biological products requesting an exemption from the GST to submit additional information as part of a license application or supplement to an approved license application. Therefore, the burden estimate for § 610.11(g)(2) is included in the estimate under §§ 601.2(a) and 601.12(b) in table 1 of this document. Section 610.67 requires certain biological products to comply with the bar code requirements at § 201.25 (21 CFR 201.25). Section 201.25 is approved under OMB control number 0910-0537 (expires February 28, 2007). Section 680.1(c) requires manufacturers to update annually their license file with the list of source materials and the suppliers of the materials. Sections 600.15(b) and 610.53(d) require the submission of a request for an exemption or modification regarding the temperature requirements during shipment and from dating periods, respectively, for certain biological products. Section 606.110(b) requires the submission of a request for approval to perform plasmapheresis of donors who do not meet certain donor requirements for the collection of plasma containing rare antibodies. Under §§ 600.15(b), 610.53(d), and 606.110(b), a request for an exemption or modification to the requirements would be submitted as a supplement. Therefore, the burden hours for any submissions under §§ 600.15(b), 610.53(d), and 606.110(b) are included in the estimates under § 601.12(b) in table 1 of this document. In July 1997, FDA revised Form FDA 356h “Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use” to harmonize application procedures between CBER and CDER. The application form serves primarily as a checklist for firms to gather and submit certain information to FDA. The checklist helps to ensure that the application is complete and contains all the necessary information, so that delays due to lack of information may be eliminated. The form provides key information to FDA for efficient handling and distribution to the appropriate staff for review. The estimated burden hours for submissions to CDER using Form FDA 356h are reported under OMB control number 0910-0001. Form FDA 2567 “Transmittal of Labels and Circulars” is used by manufacturers of licensed biological products to submit labeling (e.g., circulars, package labels, container labels, etc.) and labeling changes for FDA review and approval. The labeling information is submitted with the form for license applications, supplements, or as part of an annual report. Form FDA 2567 is also used for the transmission of advertisements and promotional labeling. Form FDA 2567 serves as an easy guide to assure that the manufacturer has provided the information required for expeditious handling of their labeling by CBER. For advertisements and promotional labeling, manufacturers of licensed biological products may submit to CBER either Form FDA 2567 or 2253. Form FDA 2253 was previously used only by drug manufacturers regulated by CDER. In August 1998, FDA revised and harmonized Form FDA 2253 so the form may be used to transmit specimens of promotional labeling and advertisements for biological products as well as for prescription drugs and antibiotics. The revised, harmonized form updates the information about the types of promotional materials and the codes that are used to clarify the type of advertisement or labeling submitted; clarifies the intended audience for the advertisements or promotional labeling (e.g., consumers, professionals, news services); and helps ensure that the submission is complete. Under table 1 of this document, the number of respondents is based on the estimated annual number of manufacturers that submitted the required information to FDA or the number of submissions FDA received. Based on information obtained from FDA's database systems, there are an estimated 306 licensed biologics manufacturers. However, not all manufacturers will have any submissions in a given year and some may have multiple submissions. The total annual responses are based on the estimated number of submissions (i.e., license applications, labeling and other supplements, protocols, advertising and promotional labeling, notifications) for a particular product received annually by FDA. Based on previous estimates, the rate of submissions is not expected to change significantly in the next few years. The hours per response are based on information provided by industry and past FDA experience with the various submissions or notifications. The hours per response include the time estimated to prepare the various submissions or notifications to FDA, and, as applicable, the time required to fill out the appropriate form and collate the documentation. Additional information regarding these estimates is provided as follows as necessary. Under §§ 601.2 and 601.12, the estimated hours per response are based on the average number of hours to submit the various submissions. The estimated average number of hours is based on the range of hours to complete a very basic application or supplement and a complex application or supplement. Under § 601.6(a), the total annual responses are based on FDA estimates that establishments may notify an average of 20 selling agents and distributors of such suspension, and provide FDA of such notification. The number of respondents is based on the estimated annual number of suspensions of a biologic license. Under §§ 601.12(f)(4) and 601.45, manufacturers of biological products may use either Form FDA 2567 or Form FDA 2253 to submit advertising and promotional labeling. Based on information obtained from FDA's database system, there were an estimated 3,600 submissions of advertising and promotional labeling in fiscal year 2004. FDA estimates that approximately 15 percent of those submissions were received with Form FDA 2567 resulting in an estimated 540 submissions. The burden hours for the remaining submissions received using Form FDA 2253 are reported under OMB control number 0910-0001. Under § 601.70(b), FDA estimates that it takes an applicant approximately 24 hours (8 hours per study x 3) annually to gather, complete, and submit the appropriate information for each postmarketing status report (approximately two to four studies per report) and the accompanied transmittal Form FDA 2252. Included in these 24 hours is the time necessary to prepare and submit two copies of the annual progress report of postmarketing studies to FDA under § 601.70(d). Under §§ 601.91 through 601.94, FDA expects to receive very few applications of this nature; however, for calculation purposes, FDA is estimating the annual submission of one application. Under §§ 601.93(b)(3) and 601.94, FDA estimates 240 hours for a manufacturer of a new biological product to develop patient labeling, and to submit the appropriate information and promotional labeling to FDA. The majority of the burden for developing the patient labeling is included under the reporting requirements for § 601.94, therefore minimal burden is calculated for providing the guide to patients under § 601.91(b)(3). There were also 3,540 amendments to an unapproved application or supplement and 23 resubmissions (total of 3,563 submissions) submitted using Form FDA 356h. In the **Federal Register** of November 2, 2006 (71 FR 64536), 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 Form FDA No. No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 601.2(a) 2 , 610.60, 610.61, and 610.62 3 2567/356h 14 2 28 860 24,080 601.5(a) NA 16 3.13 50 .33 17 601.6(a) NA 1 21 21 .33 7 601.12(a)(5) NA 190 15.7 2,983 1 2,983 601.12(b)(1)/(b)(3) 4 356h 2 190 4.75 903 80 72,240 601.12(c)(1)/(c)(3) 5 356h 2 98 2.60 255 50 12,750 601.12(c)(5) 356h 2 34 1.38 47 50 2,350 601.12(d)(1)/(d)(3) 356h 2 166 1.37 227 22.5 5,107.5 601.12(e) 356h 2 14 1.43 20 120 2,400 601.12(f)(1) 6 2567 12 1 12 40 480 601.12(f)(2) 6 2567 10 1 10 20 200 601.12(f)(3) 7 2567 70 1.43 100 10 1,000 601.12(f)(4)/601.45 2567 15 36 540 10 5,400 601.25(b)(3) NA 0 0 0 0 0 601.26(f) NA 0 0 0 0 0 601.27(b) NA 3 1 3 24 72 601.27(c) NA 7 1 7 8 56 601.28(a), (b), and

(c)NA 44 3.27 144 33.5 4,824 601.70(b) and

(d)2252 19 1.58 30 24 720 601.91(b)(3), 601.94 NA 1 1 1 240 240 610.67 NA 174 31 5,400 24 129,600 680.1(c) NA 10 1 10 2 20 Amendments/Resubmissions 356h 306 11.6 3,563 20 71,260 Total 335,806.5 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 The reporting requirements under §§ 601.14, 601.27(a), 601.33, 601.34, 601.35, 610.11(g)(2), 640.17, 640.25(c), 640.56(c), 640.74(b)(2), 660.51(a)(4), and 680.1(b)(2)(iii) are included in the estimate under § 601.2(a). 3 The reporting requirements under §§ 640.70(a), 640.74(b)(3) and (4), 640.84(a) and (c), 640.94(a), 660.2(c), 660.28(a) and (b), 660.35(a), (c-g), and (i-m), 660.45, and 660.55(a) and

(b)are included under §§ 610.60 through 610.62. 4 The reporting requirements under §§ 600.15(b), 610.11(g)(2), 610.53(d), 606.110(b), 640.6, 640.17, 640.21(c), 640.22(c), 640.25(c), 640.56(c), 640.64(c), 640.74(a) and (b)(2), and 680.1(d) are included in the estimate under § 601.12(b) 5 The reporting requirements under §§ 640.17, 640.25(c), 640.56(c), and 640.74(b)(2) are included in the estimate under § 601.12(c). 6 The reporting requirement under § 601.14 is included in the estimate under § 601.12(f)(1) and (f)(2). 7 The reporting requirement under § 601.14 is included in the estimate under § 601.12(f)(3). Under Table 2, the estimated recordkeeping burden of 1 hour is based on previous estimates for the recordkeeping requirements associated with the AER system. ** Table 2—Estimated Annual Recordkeeping Burden 1 ** 21 CFR Section No. of Recordkeepers Annual Frequency per Recordkeeping Total Annual Records Hours per Record Total Hours 601.91(b)(2)(iii) 1 1 1 1 1 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: January 26, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-1741 Filed 2-1-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006P-0052] Determination That SUSTIVA (Efavirenz) 300-Milligram Tablets Were 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 SUSTIVA (efavirenz) 300-milligram

(mg)tablets were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for efavirenz 300-mg tablets, if all other legal and regulatory requirements are met. FOR FURTHER INFORMATION CONTACT: Martha Nguyen, 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 under a new drug application (NDA). Sponsors of ANDAs do not have to repeat the extensive clinical testing otherwise necessary to gain approval of an 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 (§ 314.162 (21 CFR 314.162)). Under § 314.161(a)(1) (21 CFR 314.161(a)(1)), the agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness before an ANDA that refers to that listed drug may be approved. FDA may not approve an ANDA that does not refer to a listed drug. In a citizen petition dated January 24, 2006 (Docket No. 2006P-0052/CP1), submitted under 21 CFR 10.30, Robert W. Pollock of Lachman Consultant Services, Inc., requested that the agency determine whether SUSTIVA (efavirenz) 300-mg tablets were withdrawn from sale for reasons of safety or effectiveness. SUSTIVA (efavirenz) is approved for the treatment of human immunodeficiency virus

(HIV)type 1 infections in combination with other antiretroviral agents. SUSTIVA (efavirenz) 300-mg tablets are the subject of NDA 21-360 held by Bristol-Myers Squibb Pharma Company (BMS). FDA approved the NDA for SUSTIVA (efavirenz) 300-mg tablets on February 1, 2002. After considering the citizen petition and reviewing agency records, FDA has determined that SUSTIVA (efavirenz) 300-mg tablets were not withdrawn from sale for reasons of safety or effectiveness. To date, BMS has never marketed SUSTIVA (efavirenz) 300-mg tablets. In previous instances (see, e.g., 67 FR 79640, December 30, 2002 (addressing a relisting request for Diazepam Autoinjector)), the agency has determined that, for purposes of §§ 314.161 and 314.162, never marketing an approved drug product is equivalent to withdrawing the drug from sale. The petitioner identified no data or other information suggesting that SUSTIVA (efavirenz) 300-mg tablets were withdrawn from sale as a result of safety or effectiveness concerns. FDA has reviewed its files for records concerning the withdrawal of SUSTIVA (efavirenz) 300-mg tablets. There is no indication that the decision not to market SUSTIVA (efavirenz) 300-mg tablets commercially is a function of safety or effectiveness concerns, and no information has been submitted to the docket concerning the reasons for which SUSTIVA (efavirenz) 300-mg tablets were withdrawn from sale. FDA's independent evaluation of relevant information has uncovered nothing that would indicate that SUSTIVA (efavirenz) 300-mg tablets were withdrawn from sale for reasons of safety or effectiveness. For the reasons outlined in this document, FDA has determined that SUSTIVA (efavirenz) 300-mg tablets were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the agency will continue to list SUSTIVA (efavirenz) 300-mg tablets in 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 and effectiveness. ANDAs that refer to SUSTIVA (efavirenz) 300-mg tablets may be approved by the agency, as long as they meet all relevant legal and regulatory requirements for approval of ANDAs. Dated: January 25, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-1748 Filed 2-1-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration FDA 225-05-6001 Memorandum of Understanding Between the Food and Drug Administration, Duke University and Duke University Health System, Inc. AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is providing notice of a memorandum of understanding

(MOU)between FDA, Duke University

(DU)and Duke University Health System, Inc. (DUHS). The purpose of the MOU is to establish the terms of collaboration between FDA, DU and DUHS to support shared interests and will begin with an initiative entitled: The FDA, DU and DUMC Elective Program. DATES: The agreement became effective September 18, 2006. FOR FURTHER INFORMATION CONTACT: Nancy L. Pluhowski, Center for Devices and Radiological Health (HFZ-1), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-827-2890. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 20.108(c), which states that all written agreements and MOUs between FDA and others shall be published in the **Federal Register** , the agency is publishing notice of this MOU. Dated: January 25, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. BILLING CODE 4160-01-S EN02FE07.004 EN02FE07.005 EN02FE07.006 EN02FE07.007 EN02FE07.008 EN02FE07.009 [FR Doc. 07-454 Filed 2-1-07; 8:45 am]

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