Notices. Notice

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BILLING CODE 4160-90-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration on Aging Availability of Funding Opportunity Announcement *Funding Opportunity Title/Program Name:* National Minority Aging Organizations—Technical Assistance Centers. *Announcement Type:* Initial. *Funding Opportunity Number:* HHS-2006-AoA-HD-0607. *Statutory Authority:* The Older Americans Act of 1965, as amended, Public Law 106-501. *Catalog of Federal Domestic Assistance

(CFDA)Number:* 93.048. *Key Dates:* The deadline date for receipt of applications is July 14, 2006. I. Funding Opportunity Description The Administration on Aging

(AoA)wishes to promote improvement of the health status of racial and ethnic minority older individuals by increasing the efficiency of the NMAO Technical Assistance Centers Program to disseminate culturally competent health promotion and disease prevention information. To this end, the AoA plans to award four

(4)new cooperative agreements for National Minority Aging Organization Technical Assistance Centers (NMAOs) for the development of culturally competent and linguistically appropriate front line health promotion and disease prevention strategies for racial and ethnic minority older individuals. Projects will develop practical, nontraditional, community-based interventions for reaching older individuals who experience barriers to accessing home and community-based services due to language and low literacy as well as other barriers directly related to cultural diversity. The NMAO Centers will incorporate the latest technology to generate and disseminate knowledge in appropriate forms that can assist racial and ethnic minority older individuals to practice positive health behaviors that can strengthen their capacity to maintain active, independent life styles. Technology may be used in any number of formats or strategies from development and dissemination of CDs or DVDs or other portable electronics for senior center or at home use by older individuals, to PowerPoint Presentations for use by, as well as to train, senior center and nutrition site staff, visiting service providers, family members, etc. Technology can be especially helpful for reaching limited English speaking older individuals, both directly and through mass media such as public service announcements (PSAs). For many who may be unable to read, family members can be provided a way to help seniors get clear information which they received from an electronic device. The NMAO Centers will serve as national points of contact for tools and information on health promotion and disease prevention. They will pilot culturally competent activities and work products tailored to meet the special needs of racial and ethnic minority older individuals, including limited English speaking individuals. The awards will be cooperative agreements because the Administration on Aging will be substantially involved in the development and execution of the activities of the technical assistance centers. The Administration on Aging will work closely with the grantees to affect collaborative partnerships among the other NMAO Centers. Consultation will be provided on the development, modification and execution of Center work plans, the identification of emerging issues, potential strategies and their impact on racial and ethnic minority older individuals nationwide. A detailed description of the funding opportunity may be found at: *http://www.aoa.gov/doingbus/fundopp.asp.* II. Award Information Through this competition, AoA plans to award approximately four

(4)new cooperative agreements for new projects, for a first year total of $1,069,186. Each project should focus on older individuals in one of the following four major racial and ethnic minority groups: African American (1 project @ $294,622); American Indian and Alaska Native (1 project @ $127,669); persons of Hispanic origin (1 project @ $294,622); and Asian American and Pacific Islander (1 project @ $352,273). Projects will be funded for a 3 year period, contingent upon the availability of federal funds. Grantees are required to cover at least 25% of the total program costs from non-federal cash or in-kind resources. III. Eligibility Criteria and Other Requirements This competition is open to public and private non profit agencies and organizations, including faith- and community-based organizations (FBOs and CBOs), with a nationally known presence and the capacity to reach one of the target populations on a nationwide basis. It is not limited to previous grantees. Awards made under this competition will develop health promotion and disease prevention information that specifically targets one of the four major racial and ethnic minority groups of older individuals nationwide. For this reason, the competition is limited to organizations with national presence and the capacity to mount the type of strategic, broad based effort that can reach large segments of each population. To be considered for funding, applicants must be experienced in providing health promotion and disease prevention education to racial and ethnic minority older individuals, including persons with limited English speaking proficiency on a nationwide basis. Applicants should ideally be a well-established, known presence in their respective professional communities, and must present a comprehensive plan to allow nationwide access to products produced by the project. IV. Application and Submission Information All applicants are required to submit electronically through *http://www.grants.gov* by midnight July 14, 2006. Exceptions to this requirement may only by made by the AOA grants office. Contact Stephen Daniels (202-357-3464). Exceptions may only be made to allow for catastropic events such as tornadoes, floods, etc. Please note that applicants are responsible for mailing or hand delivering applications to AOA in sufficient time to be received by 5 p.m. eastern time July 14, 2006. 1. Address To Request Application Package Application materials can be obtained from *http://www.grants.gov* or *http://www.aoa.gov/doingbus/fundopp/fundopp.asp.* Applicants with prior approval may write for materials to: U.S. Department of Health and Human Services, Administration on Aging, Dianne A. Freeman, Center for Wellness and Community Based Services, Washington, DC 20201, or call: Dianne A. Freeman at 202-357-3536, e-mail: *Dianne.Freeman@aoa.hhs.gov.* U.S. Department of Health and Human Services, Administration on Aging, Margaret Graves, Center for Wellness and Community Based Services, Washington, DC 20201, or call: Margaret Graves at 202-357-3502, e-mail: *Margaret.Graves@aoa.hhs.gov.* Please note that AoA is requiring applications for this announcement to be submitted electronically through *http://www.grants.gov* . The Grants.gov registration process can take several days. If your organization is not currently registered with *http://www.grants.gov* , please begin this process immediately. For assistance with *http://www.grants.gov* , please contact Arthur Miller at AoA's Grants.gov helpdesk at 202-357-3438. At *http://www.grants.gov* , you will be able to download a copy of the application packet, complete it off-line, and then upload and submit the application via the Grants.gov Web site. Applications submitted via *http://www.grants.gov:* • You may access the electronic application for this program on *http://www.Grants.gov* . You must search the downloadable application page by the CFDA number (93.048). • At the *http://www.grants.gov* Web site, you will find information about submitting an application electronically through the site, including the hours of operation. AoA strongly recommends that you do not wait until the application due date to begin the application process through *http://www.grants.gov* because of the time delay. • All applicants must have a Dun and Bradstreet (D&B) Data Universal Numbering System number and register in the Central Contractor Registry (CCR). You should allow a minimum of five days to complete the CCR registration. • You may submit all documents electronically, including all information included on the SF 424 and all necessary assurances and certifications. • Your application must comply with any page limitation requirements described in this program announcement. • After you electronically submit your application, you will receive an automatic acknowledgment from * http:// www.grants.gov * that contains a Grants.gov tracking number. The Administration on Aging will retrieve your application form from Grants.gov. • We may request that you provide original signatures on forms at a later date. 2. Content and Form of Application Submission a. DUNS Number The Office of Management and Budget requires applicants to provide a Dun and Bradstreet (D&B) Data Universal Numbering System

(DUNS)number when applying for Federal grants or cooperative agreements on or after October 1, 2003. It is entered on the SF 424. It is a unique, nine-digit identification number, which provides unique identifiers of single business entities. The DUNS number is free and easy to obtain. Organizations can receive a DUNS number at no cost by calling the dedicated toll-free DUNS Number request line at 1-866-705-5711 or by using this link: *https://www.whitehouse.gov/omb/grants/duns_num_guide.pdf.* Applicants unable to submit their application via *http://www.grants.gov* may request permission to submit a hard copy from the AoA Grants Management Officer: Stephen Daniels, *daniels.stephen@aoa.hhs.gov* ,

(202)357-3464. If you mail or hand deliver your application, you must submit one original application and two copies, plus a completed application checklist to AoA. The application deadline for applications sent by U.S. Postal Service must be post-marked by midnight July 14, 2006 or hand-delivered by 5 p.m. Eastern Time on July 14, 2006. Submissions using the regular U.S. Postal Service must be addressed to: Department of Health and Human Services, Administration on Aging, Grants Management Division, Washington, DC 20201, Attention: Stephen Daniels. Submissions by courier, overnight delivery, delivered in person, etc. should be addressed to: Department of Health and Human Services, Administration on Aging, Grants Management Division, One Massachusetts Avenue, NW., Room 4604, Washington, DC 20001, Attention: Stephen Daniels. 1. Submission Dates and Times To receive consideration, applications must be received by the deadline listed in the “Dates” section of this Notice. V. Responsiveness Criteria Each application submitted will be screened to determine whether it was received by the closing date and time. Applications received by the closing date and time will be screened for completeness and conformity with the requirements outlined in Sections III and IV of this Notice and the Program Announcement. Only complete applications that meet these requirements will be reviewed and evaluated competitively. VI. Application Review Information Eligible applications in response to this announcement will be reviewed according to the following evaluation criteria: • Purpose and Need for Assistance—Weight: 20 points. • Approach/Method—Work Plan and Activities—Weight: 30 points. • Outcomes/Evaluation/Dissemination—Weight: 30 points. • Level of Effort (Organization and Management; Budget and Resources)—Weight: 20 points. VII. Agency Contacts Direct inquiries regarding programmatic issues to the U.S. Department of Health and Human Services, Administration on Aging, Center for Wellness and Community-Based Care, Washington, DC 20201, telephone:

(202)357-3464. Dated: May 30, 2006. Josefina G. Carbonell, Assistant Secretary for Aging. [FR Doc. E6-8623 Filed 6-1-06; 8:45 am] BILLING CODE 4154-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0187] Agency Information Collection Activities: Proposed Collection; Comment Request; Survey of Health Care Professionals on the Food Safety and Nutrition Information That They Provide to Pregnant Women AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the **Federal Register** concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on a voluntary survey of health care professional on the food safety and nutrition information that they provide to pregnant women. DATES: Submit written or electronic comments on the collection of information by August 1, 2006. ADDRESSES: Submit electronic comments on the collection of information to *http://www.fda.gov/dockets/ecomments* . Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget

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

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

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

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

(4)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Survey of Health Care Professionals on the Food Safety and Nutrition Information that they Provide to Pregnant Women Under section 903(b)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(b)(2)), FDA is authorized to conduct research relating to foods and to conduct educational and public information programs relating to the safety of the nation's food supply. FDA is planning to conduct a survey of health care professionals to determine what information, advice, and recommendations they are offering to pregnant women about the following topics:

(1)Methyl mercury and seafood consumption;

(2)Listeriosis prevention;

(3)weight control and nutrition;

(4)dietary supplement usage;

(5)food allergies;

(6)Toxoplasmosis prevention; and

(7)infant feeding practices. FDA is interested in obtaining this data since FDA has recently issued advice for pregnant women about food safety risks and diet risks such as mercury in seafood, Listeriosis, and Toxoplamosis. (“Food Safety for Moms-to-Be”, 2005 and “What You Need to Know about Mercury in Fish and Shellfish”, 2004). Data from this survey will be used to evaluate whether health care professionals are aware of this advice and if they are educating their patients about information in the FDA advisories. FDA will also use this survey to get a better understanding of what resources health care professionals use to stay abreast of current practices for caring for pregnant women. This will help FDA provide timely recommendations to health care professionals that will reach the largest audience. A sample of 400 obstetrician/gynecologists, 200 nurse practitioners, 200 nurse midwives, 200 physician assistants, and 200 dietitians from the Special Supplemental Nutrition Program for Women, Infants, and Children

(WIC)will be included in this survey. The sample of nurse practitioners, nurse midwives, and physician assistants will be drawn from those specializing in obstetrics. The samples will be randomly selected from lists obtained from national associations. The survey will be conducted using a mailed questionnaire. Cognitive interviews and a pretest will be conducted prior to fielding the survey. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 1,200 - Survey 1 1,200 .167 200.4 75 - Pretest 1 75 .167 12.5 16 - Cognitive Interview 1 16 .75 12 Total 1 1,291 224.9 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The burden estimate is based on FDA's experience with previous surveys. Dated: May 25, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-8566 Filed 6-1-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N-0426] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Notice of Participation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a collection of information entitled “Notice of Participation” has been approved by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: In the **Federal Register** of March 16, 2006 (71 FR 13602), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0191. The approval expires on May 31, 2009. A copy of the supporting statement for this information collection is available on the Internet at *http://www.fda.gov/ohrms/dockets* . Dated: May 25, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-8567 Filed 6-1-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N-0393] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Investigational New Drug Regulations AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a collection of information entitled “Investigational New Drug Regulations” has been approved by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995. 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 the **Federal Register** of February 17, 2006 (71 FR 8590), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0014. The approval expires on May 31, 2009. A copy of the supporting statement for this information collection is available on the Internet at *http://www.fda.gov/ohrms/dockets* . Dated: May 25, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-8568 Filed 6-1-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0081] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Marketing Act of 1987 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

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

(OMB)for review and clearance under the Paperwork Reduction Act of 1995 (the PRA). DATES: Fax written comments on the collection of information by July 3, 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: FDA Desk Officer, 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. Prescription Drug Marketing Act of 1987: Administrative Procedures, Policies, and Requirements—21 CFR Part 203—(OMB Control Number 0910-0435)—Extension FDA is requesting OMB approval under the PRA (44 U.S.C. 3501-3520) for the reporting and recordkeeping requirements contained in the regulations implementing the Prescription Drug Marketing Act of 1987

(PDMA)(Public Law 100-293). PDMA was intended to ensure that drug products purchased by consumers are safe and effective and to avoid an unacceptable risk that counterfeit, adulterated, misbranded, subpotent, or expired drugs are sold. PDMA was enacted by Congress because there were insufficient safeguards in the drug distribution system to prevent the introduction and retail sale of substandard, ineffective, or counterfeit drugs, and that a wholesale drug diversion submarket had developed that prevented effective control over the true sources of drugs. Congress found that large amounts of drugs had been reimported into the United States as U.S. goods returned causing a health and safety risk to U.S. consumers because the drugs may become subpotent or adulterated during foreign handling and shipping. Congress also found that a ready market for prescription drug reimports had been the catalyst for a continuing series of frauds against U.S. manufacturers and had provided the cover for the importation of foreign counterfeit drugs. Congress also determined that the system of providing drug samples to physicians through manufacturers' representatives had resulted in the sale to consumers of misbranded, expired, and adulterated pharmaceuticals. The bulk resale of below-wholesale priced prescription drugs by health care entities for ultimate sale at retail also helped to fuel the diversion market and was an unfair form of competition to wholesalers and retailers who had to pay otherwise prevailing market prices. FDA is requesting OMB approval for the following reporting and recordkeeping requirements: **Table 1.—Reporting Requirements** 21 CFR Section Reporting Requirements 21 CFR 203.11 Applications for reimportation to provide emergency medical care. 21 CFR 203.30(a)(1) and

(b)Drug sample requests (drug samples distributed by mail or common carrier). 21 CFR 203.30(a)(3), (a)(4), and

(c)Drug sample receipts (receipts for drug samples distributed by mail or common carrier). 21 CFR 203.31(a)(1) and

(b)Drug sample requests (drug samples distributed by means other than the mail or a common carrier). 21 CFR 203.31(a)(3), (a)(4), and

(c)Drug sample receipts (drug samples distributed by means other than the mail or a common carrier). 21 CFR 203.37(a) Investigation of falsification of drug sample records. 21 CFR 203.37(b) Investigation of a significant loss or known theft of drug samples. 21 CFR 203.37(c) Notification that a representative has been convicted of certain offenses involving drug samples. 21 CFR 203.37(d) Notification of the individual responsible for responding to a request for information about drug samples. 21 CFR 203.39(g) Preparation by a charitable institution of a reconciliation report for donated drug samples. **Table 2.—Recordkeeping Requirements** 21 CFR Section Recordkeeping Requirements 21 CFR 203.23(a) and

(b)Credit memo for returned drugs. 21 CFR 203.23(c) Documentation of proper storage, handling, and shipping conditions for returned drugs. 21 CFR 203.30(a)(2) and 21 CFR 203.31(a)(2) Verification that a practitioner requesting a drug sample is licensed or authorized to prescribe the product. 21 CFR 203.31(d)(1) and (d)(2) Contents of the inventory record and reconciliation report required for drug samples distributed by representatives. 21 CFR 203.31(d)(4) Investigation of apparent discrepancies and significant losses revealed through the reconciliation report. 21 CFR 203.31(e) Lists of manufacturers' and distributors' representatives. 21 CFR 203.34 Written policies and procedures describing administrative systems. 21 CFR 203.37(a) Report of investigation of falsification of drug sample records. 21 CFR 203.37(b) Report of investigation of significant loss or known theft of drug samples. 21 CFR 203.38(b) Records of drug sample distribution identifying lot or control numbers of samples distributed. (The information collection in 21 CFR 203.38(b) is already approved under OMB Control Number 0910-0139). 21 CFR 203.39(d) Records of drug samples destroyed or returned by a charitable institution. 21 CFR 203.39(e) Record of drug samples donated to a charitable institution. 21 CFR 203.39(f) Records of donation and distribution or other disposition of donated drug samples. 21 CFR 203.39(g) Inventory and reconciliation of drug samples donated to charitable institutions. 21 CFR 203.50(a) Drug origin statement. 21 CFR 203.50(b) Retention of drug origin statement for 3 years. 21 CFR 203.50(d) List of authorized distributors of record. The reporting and recordkeeping requirements are intended to help achieve the following goals: 1. To ban the reimportation of prescription drugs produced in the United States, except when reimported by the manufacturer or under FDA authorization for emergency medical care; 2. To ban the sale, purchase, or trade, or the offer to sell, purchase, or trade, of any prescription drug sample; 3. To limit the distribution of drug samples to practitioners licensed or authorized to prescribe such drugs or to pharmacies of hospitals or other health care entities at the request of a licensed or authorized practitioner; 4. To require licensed or authorized practitioners to request prescription drug samples in writing; 5. To mandate storage, handling, and recordkeeping requirements for prescription drug samples; 6. To prohibit, with certain exceptions, the sale, purchase, or trade of, or the offer to sell, purchase, or trade, prescription drugs that were purchased by hospitals or other health care entities, or which were donated or supplied at a reduced price to a charitable organization; and 7. To require unauthorized wholesale distributors to provide, prior to the wholesale distribution of a prescription drug to another wholesale distributor or retail pharmacy, a statement identifying each prior sale, purchase, or trade of the drug. Table 3.—Estimated Annual Reporting Burden 1 21 CFR Section No. of Respondents No. of Responses per Respondent Total Annual Responses Hours per Response Total Hours 203.11 12 1 12 .5 6 203.30(a)(1) and

(b)61,961 12 743,532 .06 44,612 203.30(a)(3), (a)(4), and

(b)232,355 135 31,367,925 .04 1,254,717 203.31(a)(3), (a)(4), and

(c)232,355 135 31,367,925 .03 941,038 203.37(a) 25 1 25 6.00 150 203.37(b) 200 1 200 6.00 1,200 203.37(c) 50 1 50 1.00 50 203.37(d) 2,208 1 2,208 .08 177 203.39(g) 3,221 1 3,221 2.00 6,442 Total Reporting Burden Hours 2,293,004 1 There are no capital costs or operating and maintenance costs associated with this collection of information. **Table 4.—Estimated Annual Recordkeeping Burden** 1 21 CFR Section No. of Respondents No. of Responses per Respondent Total Annual Responses Hours per Response Total Hours 203.23(a) and

(b)31,676 5 158,380 .25 39,595 203.23(c) 31,676 5 158,380 .08 12,670 203.30(a)(2) and 203.31(a)(2) 2,208 100 220,800 .50 110,400 203.31(d)(1) and (d)(2) 2,208 1 2,208 40.00 88,320 203.31(d)(4) 442 1 442 24.00 10,608 203.31(e) 2,208 1 2,208 1.00 2,208 203.34 2,208 1 2,208 40.00 88,320 203.37(a) 25 1 25 18.00 450 203.37(b) 200 1 200 18.00 3,600 203.39(d) 65 1 65 1.00 65 203.39(e) 3,221 1 3,221 .50 1,610 203.39(f) 3,221 1 3,221 8.00 25,768 203.39(g) 3,221 1 3,221 8.00 25,768 203.50(a) 0 0 0 0 0 203.50(b) 0 0 0 0 0 203.50(d) 0 0 0 0 0 Total Recordkeeping Burden Hours 409,409 1 There are no capital costs or operating and maintenance costs associated with this collection of information. In the **Federal Register** of March 16, 2006 (71 FR 13599), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. Dated: May 25, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-8569 Filed 6-1-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0215] Agency Information Collection Activities; Proposed Collection; Comment Request; Applications for Food and Drug Administration Approval to Market a New Drug: Patent Submission and Listing Requirements and Application of 30-Month Stays on Approval of Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug Is Valid or Will Not Be Infringed AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the reporting requirements for submission and listing of patent information associated with a new drug application (NDA), an amendment, or a supplement. DATES: Submit written or electronic comments on the collection of information by August 1, 2006. ADDRESSES: Submit electronic comments on the collection of information to: *http://www.fda.gov/dockets/ecomments* . Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Karen Nelson, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1482. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget

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

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

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

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

(4)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Applications for FDA Approval to Market a New Drug: Patent Submission and Listing Requirements and Application of 30-Month Stays on Approval of Abbreviated NDAs Certifying That a Patent Claiming a Drug Is Invalid or Will Not Be Infringed (OMB Control Number 0910-0513)—Extension FDA is requesting that OMB revise and extend approval under the PRA for the information collection contained in the final rule entitled “Applications for FDA Approval to Market a New Drug: Patent Submission and Listing Requirements and Application of 30-Month Stays on Approval of Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug Is Invalid or Will Not Be Infringed” (68 FR 36676, June 18, 2003) (the June 2003 final rule). Section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(b)(1)) requires all NDA applicants to file, as part of the NDA, “the patent number and the expiration date of any patent which claims the drug for which the applicant submitted the application or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture[,] use, or sale of the drug.” Section 505(c)(2) of the act imposes a similar patent submission obligation on holders of approved NDAs when the NDA holder could not have submitted the patent information with its application. Under section 505(b)(1) of the act, we publish patent information after approval of an NDA application in the list entitled “Approved Drug Products with Therapeutic Equivalence Evaluations” (the Orange Book). If patent information is submitted after NDA approval, section 505(c)(2) of the act directs us to publish the information upon its submission. The June 2003 final rule clarified the types of patent information that must and must not be submitted to FDA as part of an NDA, an amendment, or a supplement. The June 2003 final rule also required persons submitting an NDA, an amendment, or a supplement, or submitting information on a patent after NDA approval, to make a detailed patent declaration using required forms (Form FDA 3542a and Form FDA 3542). Certain sections of the June 2003 final rule regarding the application of 30-month stays on approval of certain abbreviated new drug applications (ANDAs) and certain other NDAs, known as 505(b)(2) applications, submitted under the act, were superseded by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, signed December 8, 2003. The affected sections of the regulations issued in the June 2003 final rule—under part 314 (21 CFR part 314), §§ 314.52(a)(3) and 314.95(a)(3)—were revoked by the technical amendment to the June 2003 final rule, published in the **Federal Register** of March 10, 2004 (69 FR 11309). Accordingly, FDA's request to extend approval under the PRA for the collection of information contained in the June 2003 final rule is revised to exclude the revoked sections of the regulations, §§ 314.52(a)(3) and 314.95(a)(3), and certain sections of the regulations, §§ 314.50(i)(1)(i) and 314.94(a)(12), which were included in the estimated annual reporting burden to describe an information collection burden associated with the revoked sections of the regulations. The reporting burden for submitting an NDA, an amendment, or supplement in accordance with § 314.50(a) through (f), and

(k)has been estimated by FDA and the collection of information has been approved by OMB under OMB control number 0910-0001, most recently until May 31, 2008 (70 FR 35099, June 16, 2005). In addition, the reporting burden associated with the previously-referenced §§ 314.50(i)(1)(i) and 314.94(a)(12), regarding patent certification requirements for 505(b)(2) applications and ANDAs also has been estimated and included within the collection of information approved by OMB under OMB control number 0910-0001. We are not re-estimating these approved burdens in this document. Only the reporting burdens associated with patent submission and listing in the final rule are estimated in this document. The information collection reporting requirements are as follows: Section 314.50(h) requires that an NDA, an amendment, or a supplement contain patent information described under § 314.53. Section 314.53 requires that an applicant submitting an NDA, an amendment, or a supplement, except as provided in § 314.53(d)(2), submit on FDA Forms 3542 and 3542a, the required patent information described in the section. Compliance with the information collection burdens under §§ 314.50(h) and 314.53 consists of submitting with an NDA, an amendment, or a supplement (collectively referred to as “application”) the required patent declaration(s) on Form FDA 3542a for each “patent that claims the drug or a method of using the drug that is the subject of the new drug application or amendment or supplement to it and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug product” (§ 314.53(b)). Such patents claim the drug substance (active ingredient), drug product (formulation and composition), or method of use. If a patent is issued after the application is filed with FDA but before the application is approved, the applicant must submit the required patent information on Form FDA 3542a as an amendment to the application, within 30 days of the date of issuance of the patent. Within 30 days after the date of approval of an application, the applicant must submit Form FDA 3542 for each patent that claims the drug substance (active ingredient), drug product (formulation and composition), or approved method of use for listing in the Orange Book. In addition, for patents issued after the date of approval of an application, Form FDA 3542 must be submitted within 30 days of the date of issuance of the patent. Following publication of the June 2003 final rule, the numbers of patents submitted to FDA for listing in the Orange Book in 2004 and 2005 were 244 and 295, respectively, for an annual average of 269.5 ((244 patents + 295 patents) / 2 years = 269.5 patents / year). Because many of these individual patents are included in multiple NDA submissions, there could be multiple declarations for a single patent. From our review of submissions, we believe that approximately 14 percent of the patents submitted are included in multiple NDA submissions, and thus require multiple patent declarations. Therefore, we estimate that 38 (269.5 patents x 14 percent) patent declarations will be multiple listings, and there will be 308 (269.5 declarations + 38 declarations = 307.5 declarations) total annual patent declarations on Form FDA 3542. As we approved 113 and 78 NDAs in 2004 and 2005, respectively, we assume there will be 96 ((113 approvals + 78 approvals) / 2 years = 95.5 approvals / year) instances where an NDA holder would be affected by the patent declaration requirements, and that each of these NDA holders would, on average, submit 3.2 (308 declarations / 96 instances = 3.2 declarations per instance) declarations on Form FDA 3542. As we received 112 and 115 NDAs in 2004 and 2005, respectively, we assume there will be 114 ((112 applications + 115 applications) / 2 years = 113.5 applications / year) instances where an NDA holder would be affected by the patent declaration requirements. We estimate, based on a proportional increase from the number of declarations for approved NDAs, that there will be an annual total of 365 (114 instances x 3.2 declarations per instance = 365 declarations) declarations on Form FDA 3542a submitted with these applications. The previous burden hour estimate of 1,684 hours for § 314.50 covered paragraphs

(a)through (f), (k), and

(h)(citing § 314.53) and FDA Forms 3542 and 3542a (see June 2003 final rule), due to the difficulty in determining what proportion of the burden hour estimate for § 314.50(a) through (f), (h), and (k), was attributable to patent declarations. Based upon information provided by regulated entities and other information, we estimate that the information collection burden associated with § 314.50(h) (citing § 314.53) and FDA Forms 3542a and 3542 will be approximately 20 hours and 5 hours per response, respectively. Thus, the information collection burden for § 314.50(h) (citing § 314.53) and FDA Forms 3542 and 3542a will decrease from the estimate we made in the June 2003 final rule for § 314.50(a) through (f), (h), and (k), and FDA Forms 3542 and 3542a of 498,464 hours to 8,840 hours ((365 annual responses x 20 hours per response = 7,300 hours) + (308 annual responses x 5 hours per response = 1,540 hours) = 8,840 total hours). FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 FDA Form No. of Respondents No. of Responses per Respondent Total Annual Responses Hours per Response Total Hours Form FDA 3542a 114 3.2 365 20 7,300 Form FDA 3542 96 3.2 308 5 1,540 Total 8,840 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: May 25, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-8570 Filed 6-1-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005D-0019] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry and Food and Drug Administration Staff on Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

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

(OMB)for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by July 3, 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: FDA Desk Officer, FAX: 202-395-6974. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Draft Guidance for Industry and FDA Staff on Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle Under the Safe Medical Devices Act of 1990 (Public Law 101-629, 104 Stat. 4511), FDA may establish special controls, including performance standards, postmarket surveillance, patient registries, guidelines, and other appropriate actions it believes necessary to provide reasonable assurance of the safety and effectiveness of the device. This draft guidance document serves as the special control to support the reclassification from class III to class II of the automated blood cell separator device operating on a centrifugal separation principle intended for the routine collection of blood and blood components (see proposed rule of March 10, 2005, 70 FR 11887), and serves as the special control for the filtration-based device with the same intended use reclassified as class II in the **Federal Register** of February 28, 2003 (68 FR 9530). The final rule for the automated blood cell separator device operating on a centrifugal separation principle will be published in conjunction with the special controls guidance document. For currently marketed products not approved under the premarket approval

(PMA)process, the manufacturer should file with FDA for 3 consecutive years an annual report on the anniversary date of the device reclassification from class III to class II, or on the anniversary date of the 510(k) clearance. Any subsequent change to the device requiring the submission of a premarket notification in accordance with section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360(k)) should be included in the annual report. Also, a manufacturer of a device determined to be substantially equivalent to the centrifugal or filtration-based automated blood cell separator device intended for the routine collection of blood and blood components, should comply with the same general and special controls. The annual report should include, at a minimum, a summary of anticipated and unanticipated donor adverse device events that have occurred, such as those required under § 606.160(b)(1)(iii) (21 CFR 606.160(b)(1)(iii)) 1 to be recorded and maintained by the facility using the device to collect blood and blood components, and that might not be reported by manufacturers under Medical Device Reporting (MDR). Also, equipment failures, including software, hardware, and disposable item failures' should be reported. The reporting of adverse device events summarized in an annual report will alert FDA to trends or clusters of events that might be a safety issue otherwise unreported under the MDR regulation. 1 Section 606.160(b)—“Records shall be maintained that include, but are not limited to, the following when applicable: * * * (1)(iii) Donor adverse reaction complaints and reports, including results of all investigations and followup.” Reclassification of this device from class III to class II for the intended use of routine collection of blood and blood components will relieve manufacturers of the burden of complying with PMA requirements of section 515 of the act (21 U.S.C. 360e), and may permit small potential competitors to enter the marketplace by reducing the burden. Although the special control guidance document recommends that manufacturers of these devices file with FDA an annual report for 3 consecutive years, this would be less burdensome than the current postapproval requirements under part 814, subpart E (21 CFR part 814, subpart E), including the submission of periodic reports under § 814.84. Collecting or transfusing facilities and manufacturers have certain responsibilities under the CFR. Among others, collecting or transfusing facilities are required to maintain records of any reports of complaints of adverse reactions (§ 606.170), while the manufacturer is responsible for conducting an investigation of each event that is reasonably known to the manufacturer and evaluating the cause of the event under part 803 (21 CFR part 803), specifically in § 803.50(b)(2). In the draft guidance document, we recommend that manufacturers include in their three annual reports a summary of adverse reactions maintained by the collecting or transfusing facility or similar reports of adverse events collected in addition to those required under the MDR regulation. In the **Federal Register** of March 10, 2005 (70 FR 11990), FDA published a 60-day notice requesting public comment on the information collection provisions. One public comment was received but it did not relate to the collection of information. **Table 1.—Estimated Annual Reporting Burden** 1 No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Respondent Total Hours Annual Report 4 1 4 5 20 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Based on FDA records, there are an estimated four manufacturers of automated blood cell separator devices. We estimate that the manufacturers will spend approximately 5 hours preparing and submitting the annual report. The total annual burden of this collection of information is estimated at approximately 20 hours. Other burden hours associated with proposed 21 CFR 864.9245 are already reported and approved under OMB control number 0910-0120 (premarket notification submission in accordance with section 510(k) of the act, and 21 CFR part 807, subpart E), and OMB control number 0910-0437 (MDR). Currently, manufacturers of medical devices are required to submit to FDA individual adverse event reports of death, serious injury, and malfunctions (§§ 803.50 and 803.53). The manufacturer is responsible for conducting an investigation of each event and evaluating the cause of the event (§ 803.50(b)(2)). The reporting recommended in the special control guidance document broadens the information to be reported by manufacturers to FDA. We are recommending that the manufacturer submit annually, for 3 consecutive years, a summary of all adverse events, including those reported under part 803. The MedWatch medical device reporting code instructions ( *http://www.fda.gov/cdrh/mdr/373.html* ), contains a comprehensive list of adverse events associated with device use, including most of those events that we recommend summarizing in the annual report. Dated: May 25, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-8571 Filed 6-1-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0197] Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of the agency's regulations that require registration for domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States. DATES: Submit written or electronic comments on the collection of information by August 1, 2006. ADDRESSES: Submit electronic comments on the collection of information to: *http://www.fda.gov/dockets/ecomments* . Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget

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

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

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

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

(4)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002—21 CFR 1.230-1.235 (OMB Control Number 0910-0502)—Extension The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) added section 415 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 350d), which requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with FDA. Sections 1.230-1.235 of FDA's regulations (21 CFR 1.230-1.235) set forth the procedures for registration of food facilities. Information provided to FDA under these regulations will help the agency to notify quickly the facilities that might be affected by a deliberate or accidental contamination of the food supply. *Description of respondents* : The respondents to this information collection include owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States. Domestic facilities are required to register whether or not food from the facility enters interstate commerce. Foreign facilities that manufacture/process, pack, or hold food also are required to register unless food from that facility undergoes further processing (including packaging) by another foreign facility before the food is exported to the United States. However, if the subsequent foreign facility performs only a minimal activity, such as putting on a label, both facilities are required to register. FDA's regulations require that each facility that manufactures, processes, packs, or holds food for human or animal consumption in the United States register with FDA using Form FDA 3537 (§ 1.231). The term “Form FDA 3537” refers to both the paper version of the form and the electronic system known as the Food Facility Registration Module, which is available at *http://www.access.fda.gov* . The agency strongly encourages electronic registration because it is faster and more convenient. The system the agency has developed can accept electronic registrations from anywhere in the world 24 hours a day, 7 days a week. A registering facility will receive confirmation of electronic registration and its registration number instantaneously once all the required fields on the registration screen are filled in. However, paper registrations will be accepted. Form FDA 3537 is available for download for registration by mail, fax, or CD-ROM. Registration by mail may take several weeks to several months, depending on the speed of the mail system and the number of paper registrations that FDA will have to enter manually. Information FDA requires on the registration form includes the name and full address of the facility; emergency contact information; all trade names the facility uses; applicable food product categories identified in § 170.3 (21 CFR 170.3), unless “most/all” human food categories “or none of the above mandatory categories” is selected as a response; and a certification statement that includes the name of the individual authorized to submit the registration form. Additionally, facilities are encouraged to submit their preferred mailing address; type of activity conducted at the facility; food categories not included under § 170.3, but which are helpful to FDA for responding to an incident; type of storage, if the facility is primarily a holding facility; and approximate dates of operation if the facility's business is seasonal. In addition to registering, a facility is required to submit timely updates within 60 days of a change to any required information on its registration form, using Form FDA 3537 (§ 1.234), and to cancel its registration when the facility ceases to operate or is sold to new owners or ceases to manufacture/process, pack, or hold food for consumption in the United States, using Form FDA 3537a (§ 1.235). FDA estimates the burden of complying with the information collection provisions of the agency's regulations for food facility registration as follows: ** Table 1.—Estimated Annual Reporting Burden 1 ** 21 CFR Section FDA Form No. Number of Respondents Annual Frequency per Respondent Total Annual Responses Hours per Response Total Hours **New Facilities** *Domestic* 1.230-1.233 FDA 3537 2 13,650 1 13,650 2.5 34,125 *Foreign* 1.230-1.233 FDA 3537 29,200 1 29,200 8.5 248,200 **New Facility Registration Subtotal** 282,325 **Previously Registered Facilities-Updates (Form 3537) and Cancellations (Form 3537** a) 1.234 FDA 3537 92,850 1 92,850 1 92,850 1.235 FDA 3537a 1,300 1 1,300 1 1,300 **Updates or Cancellations to Existing Registration Subtotal** 94,150 **Total Hours Annually** 376,475 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 The term “Form FDA 3537” refers to both the paper version of the form and the electronic system known as the Food Facility Registration Module, which is available at *http://www.access.fda.gov* . This estimate is based on FDA's experience and the average number of new facility registrations, updates and cancellations received in the past 3 years. FDA received 82,485 new domestic facility registrations during 2003; 32,099 during 2004; and 13,652 during 2005. Based on this experience, FDA estimates the annual number of new domestic facility registrations will be 13,650. FDA estimates that listing the information required by the Bioterrorism Act and presenting it in a format that will meet the agency's registration regulations will require a burden of approximately 2.5 hours per average domestic facility registration. The average domestic facility burden hour estimate of 2.5 hours takes into account that some respondents completing the registration may not have readily available Internet access. Thus, the total annual burden for new domestic facility registrations is estimated to be 34,125 hours (13,650 x 2.5 hours). FDA received 89,990 new foreign facility registrations during 2003; 49,574 during 2004; and 29,193 during 2005. Based on this experience, FDA estimates the annual number of new foreign facility registrations will be 29,200. FDA estimates that listing the information required by the Bioterrorism Act and presenting it in a format that will meet the agency's registration regulations will require a burden of approximately 8.5 hours per average foreign facility registration. The average foreign facility burden hour estimate of 8.5 hours includes an estimate of the additional burden on a foreign facility to obtain a U.S. agent, and takes into account that for some foreign facilities the respondent completing the registration may not be fluent in English and/or not have readily available Internet access. Thus, the total annual burden for new foreign facility registrations is estimated to be 248,200 hours (29,200 x 8.5 hours). FDA received 131,354 updates to facility registrations during 2003; 137,384 during 2004; and 92,835 during 2005. Based on this experience, FDA estimates that it will receive 92,850 updates annually. FDA also estimates that updating a registration will, on average, require a burden of approximately 1 hour, taking into account fluency in English and Internet access. Thus, the total annual burden for updating all registrations is estimated to be 92,850 hours. FDA received 12,556 cancellations of facility registrations during 2003; 7,467 during 2004; and 1,280 during 2005. Based on this experience, FDA estimates the annual number of cancellations will be 1,300. FDA also estimates that cancelling a registration will, on average, require a burden of approximately 1 hour, taking into account fluency in English and Internet access. Thus, the total annual burden for cancelling registrations is estimated to be 1,300 hours. In cases where a regulation implements a statutory information collection requirement, only the additional burden attributable to the regulation, if any, has been included in FDA's burden estimate. Dated: May 25, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-8574 Filed 6-1-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2000D-1318] Guidance for Industry on Chronic Cutaneous Ulcer and Burn Wounds—Developing Products for Treatment; 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 entitled “Chronic Cutaneous Ulcer and Burn Wounds—Developing Products for Treatment.” This document provides recommendations on developing products for the treatment of chronic cutaneous ulcer and burn wounds. It includes general guidance on clinical trial design as well as preclinical and manufacturing considerations. This guidance finalizes the draft guidance published on June 28, 2000. DATES: Submit written or electronic comments on agency guidances at any time. ADDRESSES: Submit written requests for single copies of this guidance to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, or the Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. Send one self-addressed adhesive label to assist that office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-1800. Submit written comments on the 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* . See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Elektra Papadopoulos, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 5189, Silver Spring, MD 20993-0002, 301-796-2110; or Susan Leibenhaut, Center for Biologics Evaluation and Research (HFM-755), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-6536; or Charles N. Durfor, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-3090. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled “Chronic Cutaneous Ulcer and Burn Wounds—Developing Products for Treatment.” On June 28, 2000 (65 FR 39912), FDA published for comment in the **Federal Register** a draft of this guidance. The guidance addresses the development of drugs, biological products, and medical devices for the treatment of burn wounds and chronic cutaneous ulcers, including venous stasis ulcers, diabetic foot ulcers, and pressure ulcers. Included are recommendations for trial design, labeling claims, outcome measures, and special considerations for preclinical development, as well as for manufacturing. Comments received from industry, professional societies, and consumer groups on the draft guidance have been taken into consideration by FDA in finalizing this guidance and some of the changes are summarized here. The accelerated wound closure section has been modified and now indicates that if claims are sought for both increased incidence of wound closure and accelerated healing, then the study should be designed to detect both effects. The section on debridement outcomes has been clarified and indicates clinically relevant endpoints for debriding agents. Newly addressed are wound pain amelioration outcomes, outcomes for temporary dressings, and recommendations for choosing lesions for evaluation of efficacy outcomes (e.g., target lesion or complete healing of all lesions reported per patient). This 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 developing products for the treatment of chronic cutaneous ulcer and burn wounds. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. 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. 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 document at either *http://www.fda.gov/cder/guidance/index.htm* , *http://www.fda.gov/cber/guidelines.htm* , or *http://www.fda.gov/ohrms/dockets/default.htm* . Dated: May 23, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-8572 Filed 6-1-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005D-0288] International Conference on Harmonisation; Guidance on Q9 Quality Risk Management; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of a guidance entitled “Q9 Quality Risk Management.” The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides principles and examples of tools for quality risk management that can be applied to all aspects of pharmaceutical quality throughout the lifecycle of drug substances, drug products, and biological and biotechnological products. The guidance is intended to enable regulators and industry to make more effective and consistent risk-based decisions. DATES: Submit written or electronic comments on agency guidance at any time. ADDRESSES: Submit written comments on the 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* . Submit written requests for single copies of the guidance to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, or the Office of Communication, Training and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. The guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-1800. Send two self-addressed adhesive labels to assist the office in processing your requests. Requests and comments should be identified with the docket number found in brackets in the heading of this document. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: *Regarding the guidance* : H. Gregg Claycamp, Center for Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-6505; Albinus D Sa, Center for Drug Evaluation and Research (HFD-320), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-9044; Anna M. Flynn, Center for Biologics Evaluation and Research (HFM-610), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-6201; or Diana J. Kolaitis, Office of Regulatory Affairs (HFR-NE1), Food and Drug Administration, 158-15 Liberty Ave., Jamaica, NY 11433, 718-662-5612. *Regarding the ICH* : Michelle Limoli, Office of International Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4480. SUPPLEMENTARY INFORMATION: I. Background In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies. ICH was organized to provide an opportunity for tripartite harmonization initiatives to be developed with input from both regulatory and industry representatives. FDA also seeks input from consumer representatives and others. ICH is concerned with harmonization of technical requirements for the registration of pharmaceutical products among three regions: The European Union, Japan, and the United States. The six ICH sponsors are the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; the Centers for Drug Evaluation and Research and Biologics Evaluation and Research; FDA; and the Pharmaceutical Research and Manufacturers of America. The ICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation of Pharmaceutical Manufacturers Associations (IFPMA). The ICH Steering Committee includes representatives from each of the ICH sponsors and the IFPMA, as well as observers from the World Health Organization, Health Canada, and the European Free Trade Area. In the **Federal Register** of August 8, 2005 (70 FR 45722), FDA published a notice announcing the availability of a draft tripartite guidance entitled “Q9 Quality Risk Management.” The notice gave interested persons an opportunity to submit comments by October 7, 2005. After consideration of the comments received and revisions to the guidance, a final draft of the guidance was submitted to the ICH Steering Committee and endorsed by the three participating regulatory agencies in November 2005. The guidance provides recommendations for a systematic approach to quality risk management. The guidance is intended to support other ICH quality documents, complement existing quality practices and standards, and enable regulators and industry to make more effective and consistent risk-based decisions. The guidance includes principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality throughout the lifecycle of drug substances, drug products, and biological and biotechnological products. These aspects include development, manufacturing, distribution, inspection, and submission/review processes (including the use of raw materials, solvents, excipients, packaging and labeling materials in drug products and biological and biotechnological products). The guidance is not intended to create any new expectations beyond current regulatory requirements. This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments on the guidance at any time. 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. The guidance and 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 document at *http://www.fda.gov/ohrms/dockets/default.htm* , *http://www.fda.gov/cder/guidance/index.htm* , or *http://www.fda.gov/cber/publications.htm* . Dated: May 23, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. > [FR Doc. E6-8573 Filed 6-1-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Neurological Disorders and Stroke; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the Neurological Sciences and Disorders A, June 22, 2006, 8 a.m. to June 23, 2006, 6 p.m. The Fairmont Washington, DC, 2401 M Street, NW., Washington, DC 20037, which was published in the **Federal Register** on May 3, 2006, 71, FR: 06-4149. This meeting was scheduled for June 22-23, 2006 and has been changed to a one day meeting on June 22, 2006; 8 a.m. to 6 p.m. The meeting is closed to the public. Dated: May 25, 2006. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 06-5061 Filed 6-1-06; 8:45 am]

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