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 4160-90-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30 Day-08-07AH] Proposed Data Collections Submitted for Public Comment and Recommendations The Centers for Disease Control and Prevention

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

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

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

(202)395-6974. Written comments should be received within 30 days of this notice. Proposed Project Qualitative Evaluation of HIV Counseling, Testing, and Referral Services in Non-Health Care Settings: Eliciting Consumer Views—New—National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Coordinating Center for Infectious Diseases (CCID), Centers for Disease Control and Prevention (CDC). Background and Brief Description Historically, HIV prevention efforts have targeted people at risk for HIV infection with the goal of keeping those who are HIV negative from becoming infected. However, the epidemic has changed with the introduction of highly active anti-retroviral therapy (HAART). People with HIV are now living longer, and with a steady incidence and increasing prevalence, an estimated 1,039,000 to 1,185,000 people are now living with HIV/AIDS in the United States. It is estimated that 25% of HIV-infected persons are not aware of their infection. Critical components in controlling the spread of HIV infection are early knowledge of HIV infection and access to treatment. Awareness of HIV infection has also been shown to reduce high risk sexual behaviors in some populations. Therefore, access to HIV counseling, testing, and referral

(CTR)services can play a significant role in reducing HIV transmission. This project involves formative research to elicit consumer opinions on HIV CTR in non-health care settings. The study entails conducting 21 focus groups with persons who are either HIV positive or at risk for HIV because of their drug injection or sexual behavior. The purpose of the focus groups is to explore:

(1)Facilitators and barriers to use CTR services in non-health care settings;

(2)ideal service components to decrease barriers to early diagnosis, decrease risk behaviors, link clients with follow-up care, and ensure client rights;

(3)perceived risks and benefits of CTR; and

(4)preferences for providing informed consent. CDC will use study findings to inform the development of new recommendations for HIV CTR in non-health care settings. We expect a total of 630 individuals to be screened for eligibility. Of those who are screened, we expect that 252 individuals will join the study and participate in a focus group. There are no costs to the respondents other than their time. The total estimated annual burden hours are 714. Estimated Annualized Burden Hours Type of respondent Form name Number of respondents Number responses per respondent Average burden per response (in hours) Prospective Participant Screener 630 1 20/60 Adult Past Clients (HIV-negative) Facilitator Guide—Adult Past Clients (HIV-negative) 60 1 2 Adult Past Clients (HIV-positive) Facilitator Guide—Adult Past Clients (HIV-positive) 60 1 2 Adult Potential Clients Facilitator Guide—Adult Potential Clients 60 1 2 Adolescents (HIV-positive) Facilitator Guide—Adolescents (HIV-positive) 24 1 2 Adolescents (HIV-negative) Facilitator Guide Adolescents (HIV-negative) 48 1 2 Dated: November 8, 2007. Maryam I. Daneshvar, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E7-22637 Filed 11-16-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0444] Agency Information Collection Activities; Proposed Collection; Comment Request; Recordkeeping and Records Access Requirements for Food Facilities 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 FDA's recordkeeping and records access requirements for food facilities. DATES: Submit written or electronic comments on the collection of information by January 18, 2008. ADDRESSES: Submit electronic comments on the collection of information to: *http://www.fda.gov/dockets/ecomments* or *http://www.regulations.gov* . 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 the Chief Information Officer (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. Recordkeeping and Records Access Requirements for Food Facilities—21 CFR 1.337, 1.345, and 1.352 (OMB Control Number 0910-0560)—Extension The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) added section 414 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 350c), which requires that persons who manufacture, process, pack, hold, receive, distribute, transport, or import food in the United States establish and maintain records identifying the immediate previous sources and immediate subsequent recipients of food. Sections 1.326 through 1.363 (21 CFR 1.326 through 1.363) of FDA's regulations set forth the requirements for recordkeeping and records access. The requirement to establish and maintain records improves FDA's ability to respond to, and further contain, threats of serious adverse health consequences or death to humans or animals from accidental or deliberate contamination of food. *Description of Respondents* : Persons that manufacture, process, pack, hold, receive, distribute, transport, or import food in the United States are required to establish and maintain records, including persons that engage in both interstate and intrastate commerce. FDA's regulations require that records for non-transporters include the name and full contact information of sources, recipients, and transporters, an adequate description of the food including the quantity and packaging, and the receipt and shipping dates (§§ 1.337 and 1.345). Required records for transporters include the names of consignor and consignee, points of origin and destination, date of shipment, number of packages, description of freight, route of movement and name of each carrier participating in the transportation, and transfer points through which shipment moved (§ 1.352). Existing records may be used if they contain all of the required information and are retained for the required time period. FDA estimates the burden of this collection of information as follows: Table 1.—Estimated Annual Recordkeeping Burden 1 21 CFR Section No. of Recordkeepers Annual Frequency of Recordkeeping Total Annual Records Hours per Record Total Hours 1.337, 1.345, and 1.352 (records maintenance) 379,493 1 379,493 13.228 5,020,000 1.337, 1.345, and 1.352 (learning for new firms) 18,975 1 18,975 4.790 90,890 Total 5,110,890 1 There are no capital costs or operating and maintenance costs associated with this collection of information. This estimate is based on FDA's estimate of the number of facilities affected by the final rule entitled “Establishment and Maintenance of Records Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002,” published in the **Federal Register** of December 9, 2004 (69 FR 71562 at 71630). With regard to records maintenance, FDA estimates that approximately 379,493 facilities will spend 13.228 hours collecting, recording, and checking for accuracy of the limited amount of additional information required by the regulations, for a total of 5,020,000 hours annually. In addition, FDA estimates that new firms entering the affected businesses will incur a burden from learning the regulatory requirements and understanding the records required for compliance. In this regard, the agency estimates the number of new firms entering the affected businesses to be five percent (5%) of 379,493, or 18,975 firms. Thus, FDA estimates that approximately 18,975 facilities will spend 4.790 hours learning about the recordkeeping and records access requirements, for a total of 90,890 hours annually. Therefore, the total annual recordkeeping burden is estimated to be 5,110,890 hours. Dated: November 13, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-22480 Filed 11-16-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 1999D-2013] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics 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

(1)Notification of any proposed change in the product, production process, quality controls or facilities;

(2)notification of results of tests and investigations related to or impacting the product;

(3)notification of products manufactured in a contract facility; and

(4)standard operating procedures. A. Notification of Any Proposed Change in the Product, Production Process, Quality Controls or Facility Each licensed manufacturer in a divided manufacturing arrangement or shared manufacturing arrangement must notify the appropriate FDA Center regarding proposed changes in the manufacture, testing, or specifications of its product, in accordance with § 601.12 (21 CFR 601.12). In the draft guidance, we recommend that each licensed manufacturer that proposes such a change should inform other participating licensed manufacturer(s) of the proposed change. For contract manufacturing arrangements, we recommend that the contract manufacturer should share with the license manufacturer all important proposed changes to production and facilities (including introduction of new products or at inspection). The license holder is responsible for reporting these changes to FDA (§ 601.12). B. Notification of Results of Tests and Investigations Related to or Impacting the Product In the draft guidance, we recommend the following for contract manufacturing arrangements: • The contract manufacturer should fully inform the license manufacturer of the results of all tests and investigations regarding or possibly having an impact on the product; and • The license manufacturer should obtain assurance from the contractor that any FDA list of inspectional observations will be shared with the license manufacturer to allow evaluation of its impact on the purity, potency, and safety of the license manufacturer's product. C. Notification of Products Manufactured in a Contract Facility In the draft guidance, we recommend for contract manufacturing arrangements that a license manufacturer cross reference a contract manufacturing facility's Master Files only in circumstances involving certain proprietary information of the contract manufacturer such as a list of all products manufactured in a contract facility. In this situation the license manufacturer should be kept informed of the types or categories of all products manufactured in the contract facility. D. Standard Operating Procedures In the draft guidance, we remind the license manufacture that the license manufacturer assumes responsibility for compliance with the applicable product and establishment standards (§ 600.3(t)) (21 CFR 600.3(t)). Therefore, if the license manufacturer enters into an agreement with a contract manufacturing facility, the license manufacturer must ensure that the facility complies with the applicable standards. An agreement between a license manufacturer and a contract manufacturing facility normally includes procedures to regularly assess the contract manufacturing facility's compliance. These procedures may include, but are not limited to, review of records and manufacturing deviations and defects, and periodic audits. For shared manufacturing arrangements, each manufacturer must submit a separate biologics license application describing the manufacturing facilities and operations applicable to the preparation of that manufacturer's biological substance or product (§ 601.2(a)) (21 CFR 601.2(a)). In this draft guidance, we expect the manufacturer that prepares (or is responsible for the preparation of) the product in final form for commercial distribution to assume primary responsibility for providing data demonstrating the safety, purity, and potency of the final product. We also expect the licensed finished product manufacturer to be primarily responsible for any postapproval obligations, such as postmarketing clinical trials, additional product stability studies, complaint handling, recalls, postmarket reporting of the dissemination of advertising and promotional labeling materials as required under § 601.12(f)(4) and adverse experience reporting. We recommend that the final product manufacturer establish a procedure with the other participating manufacturer(s) to obtain information in these areas. *Description of Respondents* : The recordkeeping and reporting recommendations described in this document affect the participating licensed manufacturer(s), final product manufacturer(s), and contract manufacturer(s) associated with cooperative manufacturing arrangements. *Burden Estimate* : We believe that the information collection provisions in the draft guidance do not create a new burden for respondents. We believe the reporting and recordkeeping provisions are part of usual and customary business practice. Licensed manufacturers would have contractual agreements with participating licensed manufacturers, final product manufacturers, and contract manufacturers, as applicable for the type of cooperative manufacturing arrangement, to address all these information collection provisions. This draft guidance also refers to previously approved collections of information found in FDA regulations at parts 201, 207, 211, 600, 601, 606, 607, 610, 660, 803, and 807 (21 CFR parts 201, 207, 211, 600, 601, 606, 607, 610, 660, 803, and 807). The collections of information in §§ 606.121, 606.122, and 610.40 have been approved under OMB Control No. 0910-0116; § 610.2 has been approved under OMB Control No. 0910-0206; §§ 600.12(e) and 600.80 have been approved under OMB Control No. 0910-0308; §§ 601.2(a), 601.12, 610.60, 610.61, 610.62, 610.67, 660.2(c), 660.28(a) and (b), 660.35(a),

(c)through (g), and

(i)through (m), 660.45, and 660.55(a) and

(b)have been approved under OMB Control No. 0910-0338; §§ 803.20, 803.50, and 803.53 have been approved under OMB Control No. 0910-0437; and §§ 600.14 and 606.171 have been approved under OMB Control No. 0910-0458. The current good manufacturing practice regulations for finished pharmaceuticals (part 211) have been approved under OMB Control No. 0910-0139; the establishment registration regulations (parts 207, 607, and 807) have been approved under OMB Control Nos. 0910-0045, 0910-0052, and 0910-0387; and the labeling regulations (part 201) have been approved under OMB Control Nos. 0910-0340 and 0910-0370. In the **Federal Register** of July 23, 2007 (72 FR 40157), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received on the information collection. Dated: November 13, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-22489 Filed 11-16-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0325] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices: Recommended Glossary and Educational Outreach to Support Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

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

(1)In vitro diagnostic devices (IVDs), intended for professional use under 21 CFR 809.10, FDA's labeling requirements for IVDs, and

(2)FDA's labeling requirements for biologics, including IVDs under 21 CFR parts 610 and 660. Under section 502(c) of the FFD&C Act, a drug or device is misbranded, “If any word, statement, or other information required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.” The guidance document recommends that a glossary of terms accompany each IVD to define the symbols used on that device's labels and/or labeling. Furthermore, the guidance recommends an educational outreach effort to enhance the understanding of newly introduced symbols. Both the glossary and educational outreach information will help to ensure that IVD users will have enough general familiarity with the symbols used, as well as provide a quick reference for available materials, thereby further ensuring that such labeling satisfies the labeling requirements under section 502(c) of the FFD&C Act and section 351 of the PHS Act. In the **Federal Register** of August 31, 2007 (72 FR 50373), FDA published a 60-day notice soliciting public comment on the proposed collection of information provisions. No comments were received. The likely respondents for this collection of information are IVD manufacturers who plan to use the selected symbols in place of text on the labels and/or labeling of their IVDs. FDA estimates the burden for this collection of information as follows: **Estimated Annual Reporting Burden** 1 Section 502 FFD&C Act/Section 351 PHS Act No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours Glossary 1,742 1 1,742 4 6,968 2 Educational Outreach 1,742 1 1,742 16 27,872 Total 34,840 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 One time burden. The glossary and educational outreach activities are inclusive of both domestic and foreign IVD manufacturers. The Center for Devices and Radiological Health's “Information Retrieval System's Registration and Listing Information” database listed the total number of IVD manufacturers as 1,742. From this total, 1,206 of the IVD manufacturers were listed as domestic and 536 were listed as foreign manufacturers. Consequently, FDA has based its burden estimate on the maximum possible number of manufacturers choosing to implement the use of symbols in labeling. The number of hours per response for the glossary and educational outreach activities were derived from consultation with a trade association and FDA personnel. The 4-hour estimate for a glossary is based on the average time necessary for a manufacturer to modify the glossary for the specific symbols used in labels or labeling for the IVDs manufactured. The 16-hour estimate for educational outreach, is inclusive of activities manufacturers used to educate the various professional users of IVDs regarding the meaning of the IVD symbols. Further, this estimate is based on FDA's expectation that IVD manufacturers will jointly sponsor many more educational outreach activities. Dated: November 13, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-22492 Filed 11-16-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0219] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Drug User Fees and Fee Waivers and Reductions 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 December 19, 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, or e-mailed to *baguilar@omb.eop.gov* . All comments should be identified with the OMB control number 0910-0540. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Denver Presley Jr., Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Animal Drug User Fees and Fee Waivers and Reductions-21 CFR Part 740 (OMB Control Number 0910-0540)—Extension Enacted on November 18, 2003, the Animal Drug User Fee Act (ADUFA) (Public Law 108-130), amended the Federal Food, Drug, and Cosmetic Act and requires FDA to assess and collect user fees for certain applications, products, establishments, and sponsors. It also requires the agency to grant a waiver from, or a reduction of, those fees in certain circumstances. Thus, to implement this statutory provision of ADUFA, FDA developed a guidance entitled “Guidance for Industry: Animal Drug User Fees and Fee Waivers and Reductions.” This document provides guidance on the types of fees FDA is authorized to collect under ADUFA, and how to request waivers and reductions from FDA's animal drug user fees. Further, this guidance also describes the types of fees and fee waivers and reductions, what information FDA recommends be submitted in support of a request for a fee waiver or reduction, how to submit such a request, and FDA's process for reviewing requests. Requests for waivers or reductions may be submitted by a person paying any of the animal drug user fees assessed—application fees, product fees, establishment fees, or sponsor fees. In the **Federal Register** of June 14, 2007 (72 FR 32851), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. Respondents to this collection of information are new animal drug sponsors. FDA estimates the burden for this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 21 CFR Section No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 740(d)(1)(A) Significant barrier to innovation 5 1 time for each application 5 2 10 740(d)(1)(B) Fees exceed cost 1 do. 1 2 2 740(d)(1)(C) Free choice feeds 5 do. 5 2 10 740(d)(1)(D) Minor use or minor species 10 do. 10 2 20 740(d)(1)(E) Small business 2 do. 2 2 4 Request for reconsideration of a decision 5 do. 5 2 10 Request for review—(user fee appeal officer) 2 do. 2 2 4 Total 60 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Based on FDA's database system, there are an estimated 250 sponsors of products subject to ADUFA. However, not all sponsors will have any submissions in a given year and some may have multiple submissions. The total number of waiver requests is based on the number of submission types received by FDA in fiscal year 2003. FDA's Center for Veterinary Medicine estimates 30 waiver requests that include the following: 5 significant barriers to innovation, 1 fee exceed cost, 5 free choice feeds, 10 minor use or minor species, 2 small business waiver requests, 5 requests for reconsideration of a decision, and 2 requests for user fee appeal officer. The estimated hours per response are based on past FDA experience with the various waiver requests in FDA's Center for Drug Evaluation and Research. The hours per response are based on the average of these estimates. Dated: November 13, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-22495 Filed 11-16-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No 2007N-0227] Agency Information Collection Activities: Submission for Office of Management and Budget Review; Comment Request; Medical Devices Third-Party Review Under the Food and Drug Administration Modernization Act 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 December 19, 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, or e-mailed to *baguilar@omb.eop.gov* . All comments should be identified with the OMB control number 0910-0375. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Medical Devices Third-Party Review Under the Food and Drug Administration Modernization Act; Section 523 of the Federal Food, Drug, and Cosmetic Act (OMB Control Number 0910-0375)—Extension Section 210 of the Food and Drug Administration Modernization Act (FDAMA) established section 523 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360m), directing FDA to accredit persons in the private sector to review certain premarket applications and notifications. Participation in this third-party review program by accredited persons is entirely voluntary. A third party wishing to participate will submit a request for accreditation to FDA. Accredited third-party reviewers have the ability to review a manufacturer's 510(k) submission for selected devices. After reviewing a submission, the reviewer will forward a copy of the 510(k) submission, along with the reviewer's documented review and recommendation to FDA. Third-party reviewers should maintain records of their 510(k) reviews and a copy of the 510(k) for a reasonable period of time, usually a period of 3 years. This information collection will allow FDA to continue to implement the accredited person review program established by FDAMA and improve the efficiency of 510(k) review for low to moderate risk devices. In the **Federal Register** of June 21, 2007 (72 FR 34257), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. Respondents to this information collection are businesses or other for-profit organizations. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 Section 523 of the act No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours Requests for accreditation 1 1 1 24 24 510(k) reviews conducted by accredited third parties 14 24 336 40 13,440 Total 13,464 1 There are no capital costs or operating and maintenance costs associated with this collection of information. **Table 1.—Estimated Annual Recordkeeping Burden** 1 Section 523 of the act No. of Recordkeepers Annual Frequency per Record Total Annual Records Hours per Recordkeeper Total Hours 510(k) reviews by third-party reviewers 14 24 336 10 3,600 1 There are no capital costs or operating and maintenance costs associated with this collection of information. I. Reporting A. Requests for Accreditation FDA now has approximately 8 years of experience with third-party reviews under section 523 of the act. Currently there are 11 active accredited third parties. FDA does not expect to receive more than 1 application for accreditation per year for a total of 14 accredited third parties who will be conducting third-party reviews. B. 510(k) Reviews Conducted by Accredited Third Parties FDA has received 784 510(k) submissions with a third-party review since 2004. FDA estimates that over the next 3 years, they will accredit 1 third-party reviewer per year for a total of 14 third parties. Each third-party reviewer expects to review a total of 24 510(k) submissions per year for an annual total of 336 applications. II. Recordkeeping Third-party reviewers are required to keep records of their review of each submission. At the end of 3 years, the agency expects to have 14 accredited persons for review with each third party reviewing on average 24 510(k) applications per year. The agency anticipates approximately 336 510(k) annual submissions for third-party review. Dated: November 14, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-22586 Filed 11-16-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0305] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds 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

(cGMP)regulations for drugs, including medicated feeds. Medicated feeds are administered to animals for the prevention, cure, mitigation, or treatment of disease, or growth promotion and feed efficiency. Statutory requirements for cGMPs have been codified under part 225 (21 CFR part 225). Medicated feeds that are not manufactured in accordance with these regulations are considered adulterated under section 501(a)(2)(B) of the act. Under part 225, a manufacturer is required to establish, maintain, and retain records for a medicated feed, including records to document procedures required during the manufacturing process to assure that proper quality control is maintained. Such records would, for example, contain information concerning receipt and inventory of drug components, batch production, laboratory assay results (i.e. batch and stability testing), labels, and product distribution. This information is needed so that FDA can:

(1)Monitor drug usage and possible misformulation of medicated feeds,

(2)investigate violative drug residues in products from treated animals, and

(3)investigate product defects when a drug is recalled. In addition, FDA will use the cGMP criteria under part 225 to determine whether or not the systems and procedures used by manufacturers of medicated feeds are adequate to assure that their feeds meet the requirements of the act as to safety and also that they meet their claimed identity, strength, quality, and purity, as required by section 501(a)(2)(B) of the act. A license is required when the manufacturer of a medicated feed involves the use of a drug or drugs that FDA has determined requires more control because of the need for a withdrawal period before slaughter or because of carcinogenic concerns. Conversely, a license is not required and the recordkeeping requirements are less demanding for those medicated feeds for which FDA has determined that the drugs used in their manufacture need less control. In the **Federal Register** of August 16, 2007 (72 FR 46089), FDA published a 60-day notice soliciting public comment on the proposed collection of information provisions. In response to that notice, no comments were received. Respondents to this collection of information are commercial feed mills and mixer-feeders. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Recordkeeping Burden (Registered Licensed Commercial Feed Mills)** 1 21 CFR Section No. of Recordkeepers Annual Frequency per Recordkeeper Total Annual Records Hours per Recordkeeper Total Hours 225.58(c) and

(d)1,060 45 47,700 .5 23,850 225.80(b)(2) 1,060 1,600 1,696,000 .12 203,520 225.102(b)(1) 1,060 7,800 8,268,000 .08 661,440 225.110(b)(1) and (b)(2) 1,060 7,800 8,268,000 .015 124,020 225.115(b)(1) and (b)(2) 1,060 5 5,300 .12 636 Total 1,289,066 1 There are no capital or operating and maintenance costs associated with this collection of information. **Table 2.—Estimated Annual Recordkeeping Burden (Registered Licensed Mixer-Feeders)** 1 21 CFR Section No. of Recordkeepers Annual Frequency per Recordkeeping Total Annual Records Hours per Recordkeeper Total Hours 225.42(b)(5) through (b)(8) 100 260 26,000 .15 3,900 225.58(c) and

(d)100 36 3,600 .5 1,800 225.80(b)(2) 100 48 4,800 .12 576 225.102(b)(1) through (b)(5) 100 260 26,000 .4 10,400 Total 16,676 1 There are no capital costs or operating and maintenance costs associated with this collection of information. **Table 3.—Estimated Annual Recordkeeping Burden (Nonregistered Unlicensed Commercial Feed Mills)** 1 21 CFR Section No. of Recordkeepers Annual Frequency per Recordkeeping Total Annual Records Hours per Recordkeeper Total Hours 225.142 8,000 4 32,000 1 32,000 225.158 8,000 1 8,000 4 32,000 225.180 8,000 96 768,000 .12 92,160 225.202 8,000 260 2,080,000 .65 1,352,000 Total 1,508,160 1 There are no capital costs or operating and maintenance costs associated with this collection of information. **Table 4.—Estimated Annual Recordkeeping Burden (Nonregistered Unlicensed Mixer-Feeders)** 1 21 CFR Section No. of Recordkeepers Annual Frequency per Recordkeeping Total Annual Records Hours per Recordkeeper Total Hours 225.142 45,000 4 180,000 1 180,000 225.158 45,000 1 45,000 4 180,000 225.180 45,000 32 1,440,000 .12 172,000 225.202 45,000 260 11,700,000 .33 3,861,000 Total 4,393,000 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The estimate of the times required for record preparation and maintenance is based on agency communications with industry. Other information needed to finally calculate the total burden hours (i.e., number of recordkeepers, number of medicated feeds being manufactured, etc.) is derived from agency records and experience. Dated: November 13, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-22587 Filed 11-16-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0278] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Registration of Cosmetic Product Establishments 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 December 19, 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, or e-mailed to *baguilar@omb.eop.gov* . All comments should be identified with the OMB control number 0910-0027. Also include the FDA docket number found in brackets in the heading of this document. 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. Voluntary Registration of Cosmetic Product Establishments—(OMB Control Number 0910-0027)—Extension The Federal Food, Drug, and Cosmetic Act (the act) provides FDA with the responsibility for assuring consumers that cosmetic products in the United States are safe and properly labeled. Cosmetic products that are adulterated under section 601 of the act (21 U.S.C. 361) or misbranded under section 602 of the act (21 U.S.C. 362) may not be distributed in interstate commerce. To assist FDA in carrying out its responsibility to regulate cosmetics, FDA has developed the Voluntary Cosmetic Registration Program (VCRP). In 21 CFR part 710, FDA requests that establishments that manufacture or package cosmetic products register with the agency on Form FDA 2511 entitled “Registration of Cosmetic Product Establishment.” The term “Form FDA 2511” refers to both the paper and electronic versions of the form. The electronic version of Form FDA 2511 is available on FDA's VCRP Web site at *http://www.cfsan.fda.gov/~dms/cos-regn.html* . FDA's online registration system, intended to make it easier to participate in the VCRP, was made available industry-wide on December 1, 2005. The agency strongly encourages electronic registration of Form FDA 2511 because it is faster and more convenient. A registering facility will receive confirmation of electronic registration, including a registration number, by e-mail, usually within 7 business days. The online system also allows for amendments to past submissions. Submission of the paper version of Form FDA 2511 remains an option as described in *http://www.cfsan.fda.gov/~dms/cos-reg2.html* . However, due to the high volume of online participation, the VCRP is allocating its limited resources primarily to electronic registrations. Because registration of cosmetic product establishments is not mandatory, voluntary registration provides FDA with the best information available about the locations, business trade names, and types of activity (manufacturing or packaging) of cosmetic product establishments. FDA places the registration information in a computer database and uses the information to generate mailing lists for distributing regulatory information and for inviting firms to participate in workshops on topics in which they may be interested. FDA also uses the information for estimating the size of the cosmetic industry and for conducting onsite establishment inspections. Registration is permanent, although FDA requests that respondents submit an amended Form FDA 2511 if any of the originally submitted information changes. In the **Federal Register** of July 19, 2007 (72 FR 39626), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. FDA estimates the burden of this information collection as follows: **Table 1.—Estimated Annual Reporting Burden** 1 21 CFR Part Form No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 710 FDA 2511 135 1 135 0.2 27 1 There are no capital costs or operating and maintenance costs associated with this collection of information. FDA bases its estimate on its review of the registrations received over the past 3 fiscal years. The total annual responses (averaged over fiscal years 2004 through 2006) is 9 times the previous total reported in 2004 (for fiscal years 2000 through 2003) due to increased participation by cosmetic companies, because of a renewed industry commitment to the program, and implementation of the online registration system on December 1, 2005. Due to the ease of online registration, FDA estimates that the hours per response have declined from 0.4 hours to 0.2 hours. Thus, the total estimated hour burden for this information collection is 27 hours, which is 4.5 times the previous level reported in 2004. Dated: November 13, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-22588 Filed 11-16-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006F-0058] ARCH Chemicals, Inc.; Withdrawal of Food Additive Petition FAP 6B4764 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the withdrawal, without prejudice to a future filing, of a food additive petition (FAP 6B4764) proposing that the food additive regulations be amended to provide for the safe use of poly (iminoimidocarbonyliminoimidocarbonyliminohexamethylene) hydrochloride (CAS Reg No. 32289-58-0) as an antimicrobial agent in the manufacture of food-contact paper and paperboard. FOR FURTHER INFORMATION CONTACT: Elizabeth S. Furukawa, Center for Food Safety and Applied Nutrition (HFS-275), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1216, e-mail: *Elizabeth.Furukawa@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: In a notice published in the **Federal Register** of February 15, 2006 (71 FR 7975), FDA announced that a food additive petition (FAP 6B4764) had been filed by ARCH Chemicals, Inc., 1955 Lake Park Dr., suite 100, Smyrna, GA 30080. The petition proposed to amend the food additive regulations in 21 CFR 176.170 *Components of paper and paperboard in contact with aqueous and fatty foods* and 21 CFR 176.180 *Components of paper and paperboard in contact with dry food* to provide for the safe use of poly (iminoimidocarbonyliminoimidocarbonyliminohexamethylene) hydrochloride (CAS Reg. No. 32289-58-0) as an antimicrobial agent in the manufacture of food-contact paper and paperboard. ARCH Chemicals, Inc., has now withdrawn the petition without prejudice to a future filing (21 CFR 171.7). Dated: November 9, 2007. Laura M. Tarantino, Director, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition. [FR Doc. E7-22536 Filed 11-16-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [FDA 225-07-7001] Memorandum of Understanding Between the Food and Drug Administration and the Association of American Feed Control Officials 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 and the Association of American Feed Control Officials (AAFCO). The purpose of this MOU is to facilitate FDA's collaboration with AAFCO in the AAFCO New and Modified Ingredient Definition Process by clarifying the responsibilities of FDA and AAFCO in defining feed ingredients, in providing mechanisms for resolving disputes that may arise, and in providing mechanisms for modifying the ingredient definition process when required. DATES: The agreement became effective August 30, 2007. FOR FURTHER INFORMATION CONTACT: Sharon Benz, Division of Animal Feeds (HFV-220), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-453-6864. 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: November 12, 2007. Randall W. Lutter, Deputy Commissioner for Policy. BILLING CODE 4160-01-S EN19NO07.016 EN19NO07.017 EN19NO07.018 EN19NO07.019 [FR Doc. 07-5748 Filed 11-16-07; 8:45 am]

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