Notices. Notice

9,258 words·~42 min read·/register/2006/07/24/06-6432

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

BILLING CODE 4184-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N-0123] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Survey of Need for Online Medical Device Survey 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 August 23, 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: Denver Presley, Office of Management Programs (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. Survey of Need for Online Medical Device Information Executive Order 12862 directs agencies to identify the customers who are, or should be, served by the agency, and to survey customers to determine the kind and quality of services they want. This proposed survey will collect data about the information customers want when looking up medical devices on the Internet. It will focus on the ways individuals find, use, and rate existing sources of online medical device information. FDA will use this data to understand more about its customers and to make improvements to its own Web site. FDA will administer this survey to individuals who use the Internet to look for information about medical devices. The survey will consist of three components: A screening tool of 5,000 to identify appropriate respondents, an online survey of 500 customers, and a telephone followup interview with 50 customers. In the **Federal Register** of April 20, 2005 (70 FR 20573), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received in response to that notice. FDA estimates the burden for this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 21 CFR (Or FDA Form #) No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours Screening Tool 5,000 1 5,000 0.05 250 Online Survey 500 1 500 0.25 125 Telephone 2 Follow-Up - - - - - Total 375 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 This was listed in the **Federal Register** announcement but is no longer required in the survey. Dated: July 17, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-11640 Filed 7-21-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0279] Agency Information Collection Activities; Proposed Collection; Comment Request; Bar Code Label Requirement for Human Drug and Biological Products 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 bar code label requirements for human drug and biological products. DATES: Submit written or electronic comments on the collection of information by September 22, 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: Elizabeth Berbakos, 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. Bar Code Label Requirement for Human Drug and Biological Products In the **Federal Register** of February 26, 2004 (69 FR 9120), we issued a new rule that required human drug product and biological product labels to have bar codes. The rule required bar codes on most human prescription drug products and on over-the-counter

(OTC)drug products that are dispensed under an order and commonly used in health care facilities. The rule also required machine-readable information on blood and blood components. For human prescription drug products and OTC drug products that are dispensed under an order and commonly used in health care facilities, the bar code must contain the National Drug Code number for the product. For blood and blood components, the rule specifies the minimum contents of the machine-readable information in a format approved by the Center for Biologics Evaluation and Research Director as blood centers have generally agreed upon the information to be encoded on the label. The rule is intended to help reduce the number of medication errors in hospitals and other health care settings by allowing health care professionals to use bar code scanning equipment to verify that the right drug (in the right dose and right route of administration) is being given to the right patient at the right time. Most of the information collection burden resulting from the final rule, as calculated in table 1 of the final rule (69 FR 9120 at 9149), was a one-time burden that does not occur after the rule's compliance date of April 26, 2006. In addition, some of the information collection burden estimated in the final rule is now covered in other OMB-approved information collection packages for FDA. However, parties may continue to seek an exemption from the bar code requirement under certain, limited circumstances. Section 201.25(d) (21 CFR 201.25(d)) requires submission of a written request for an exemption and describes the contents of such requests. Based on the number of exemption requests submitted during 2004 and 2005, we estimate that approximately 2 waiver requests may be submitted annually, and that each exemption request will require 24 hours to complete. This would result in an annual reporting burden of 48 hours. ** Table 1.—Estimated Annual Reporting Burden 1 ** 21 CFR Section No. of Respondents No. of Responses Per Respondent Total Annual Responses Hours per Response Total Hours 201.25(d) 2 1 2 24 48 Total 48 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: July 17, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-11641 Filed 7-21-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0277] Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Notification Procedures for Statements on Dietary Supplements 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 regulation requiring manufacturers, packers, and distributors of dietary supplements to notify FDA that they are marketing a dietary supplement product that bears on its label or in its labeling a statement provided for in the Federal Food, Drug, and Cosmetic Act (the act). DATES: Submit written or electronic comments on the collection of information by September 22, 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

(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. Food Labeling; Notification Procedures for Statements on Dietary Supplements—21 CFR 101.93 (OMB Control Number 0910-0331)—Extension Section 403(r)(6) of the act (21 U.S.C 343(r)(6)) requires that the agency be notified by manufacturers, packers, and distributors of dietary supplements that they are marketing a dietary supplement product that bears on its label or in its labeling a statement provided for in section 403(r)(6) of the act. Section 403(r)(6) of the act requires that the agency be notified, with a submission about such statements, no later than 30 days after the first marketing of the dietary supplement. Information that is required in the submission includes:

(1)The name and address of the manufacturer, packer, or distributor of the dietary supplement product;

(2)the text of the statement that is being made;

(3)the name of the dietary ingredient or supplement that is the subject of the statement;

(4)the name of the dietary supplement (including the brand name); and

(5)a signature of a responsible individual who can certify the accuracy of the information presented, and who must certify that the information contained in the notice is complete and accurate, and that the notifying firm has substantiation that the statement is truthful and not misleading. The agency established § 101.93 (21 CFR 101.93) as the procedural regulation for this program. Section 101.93 provides details of the procedures associated with the submission and identifies the information that must be included in order to meet the requirements of section 403 of the act. *Description of Respondents* : Businesses or other for-profit organizations. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 21 CFR Section No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Respondent Total Hours 101.93 2,500 1 2,500 .75 1,875 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The agency believes that there will be minimal burden on the industry to generate information to meet the requirements of section 403 of the act in submitting information regarding section 403(r)(6) of the act statements on labels or in labeling of dietary supplements. The agency is requesting only information that is immediately available to the manufacturer, packer, or distributor of the dietary supplement that bears such a statement on its label or in its labeling. This estimate is based on the average number of notification submissions received by the agency in the preceding 12 months. Dated: July 17, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-11642 Filed 7-21-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0278] Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Continuous Marketing Applications: Pilot 2—Scientific Feedback and Interactions During Development of Fast Track Products Under the Prescription Drug User Fee Act 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 contained in the guidance for industry on Continuous Marketing Applications: Pilot 2—Scientific Feedback and Interactions During Development of Fast Track Products Under the Prescription Drug User Fee Act. DATES: Submit written or electronic comments on the collection of information by September 22, 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: Elizabeth Berbakos, 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 **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. Guidance for Industry on Continuous Marketing Applications: Pilot 2—Scientific Feedback and Interactions During Development of Fast Track Products Under the Prescription Drug User Fee Act—(OMB Control Number 0910-0518)— Extension FDA is requesting OMB approval under the PRA (44 U.S.C. 3507) for the reporting and recordkeeping requirements contained in the guidance for industry entitled “Continuous Marketing Applications (CMA): Pilot 2—Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA.” This guidance discusses how the agency will implement a pilot program for frequent scientific feedback and interactions between FDA and applicants during the investigational phase of the development of certain Fast Track drug and biological products. Applicants are asked to apply to participate in the Pilot 2 program. In conjunction with the June 2002 reauthorization of the Prescription Drug User Fee Act of 1992 (PDUFA), FDA agreed to meet specific performance goals (PDUFA Goals). The PDUFA Goals include two pilot programs to explore the CMA concept. The CMA concept builds on the current practice of interaction between FDA and applicants during drug development and application review and proposes opportunities for improvement. Under the CMA pilot program, Pilot 2, certain drug and biologic products that have been designated as Fast Track (i.e., products intended to treat a serious and/or life-threatening disease for which there is an unmet medical need) are eligible to participate in the program. Pilot 2 is an exploratory program that allows FDA to evaluate the impact of frequent scientific feedback and interactions with applicants during the investigational new drug application

(IND)phase. Under the pilot program, a maximum of 1 Fast Track product per review division in FDA's Center for Drug Evaluation and Research

(CDER)and Center for Biologics Evaluation and Research

(CBER)is selected to participate. This guidance provides information regarding the selection of participant applications for Pilot 2, the formation of agreements between FDA and applicants on the IND communication process, and other procedural aspects of Pilot 2. FDA began accepting applications for participation in Pilot 2 on October 1, 2003. The guidance describes 1 collection of information: Applicants who would like to participate in Pilot 2 must submit an application (Pilot 2 application) containing certain information outlined in the guidance. The purpose of the Pilot 2 application is for the applicants to describe how their designated Fast Track product would benefit from enhanced communications between FDA and the applicant during the product development process. FDA's regulation at § 312.23 (21 CFR 312.23) states that information provided to the agency as part of an IND must be submitted in triplicate and with an appropriate cover form. Form FDA 1571 must accompany submissions under INDs. 21 CFR part 312 and FDA Form 1571 have a valid OMB control number: OMB control number 0910-0014, which expires May 31, 2009. In the guidance document, CDER and CBER ask that a Pilot 2 application be submitted as an amendment to the application for the underlying product under the requirements of § 312.23; therefore, Pilot 2 applications should be submitted to the agency in triplicate with Form FDA 1571. The agency recommends that a Pilot 2 application be submitted in this manner for two reasons:

(1)To ensure that each Pilot 2 application is kept in the administrative file with the entire underlying application, and

(2)to ensure that pertinent information about the Pilot 2 application is entered into the appropriate tracking databases. Use of the information in the agency's tracking databases enables the agency to monitor progress on activities. Under the guidance, the agency asks applicants to include the following information in the Pilot 2 application: • Cover letter prominently labeled “Pilot 2 application;” • IND number; • Date of Fast Track designation; • Date of the end-of-phase 1 meeting, or equivalent meeting, and summary of the outcome; • A timeline of milestones from the drug or biological product development program, including projected date of new drug application (NDA)/biologics license application

(BLA)submissions; • Overview of the proposed product development program for a specified disease and indication(s), providing information about each of the review disciplines (e.g., chemistry/manufacturing/controls, pharmacology/toxicology, clinical, clinical pharmacology and biopharmaceutics); • Rationale for interest in participating in Pilot 2, specifying the ways in which development of the subject drug or biological product would be improved by frequent scientific feedback and interactions with FDA and the potential for such communication to benefit public health by improving the efficiency of the product development program; and • Draft agreement for proposed feedback and interactions with FDA. This information is used by the agency to determine which Fast Track products are eligible for participation in Pilot 2. Participation in this pilot program is voluntary. Based on the number of Pilot 2 applications submitted to CDER and CBER during fiscal year 2004 and 2005, we estimate that the number of applications received annually for Pilot 2 is 7 for products regulated by CDER and 1 for products regulated by CBER. FDA anticipates that approximately 7 applicants (respondents) will submit these Pilot 2 applications annually to CDER and approximately 1 applicant (respondent) will submit these Pilot 2 applications annually to CBER. The hours per response, which is the estimated number of hours that a respondent would spend preparing the information to be submitted in a Pilot 2 application in accordance with the guidance, is estimated to be approximately 80 hours. Based on FDA's experience, we expect it will take respondents this amount of time to obtain and draft the information to be submitted with a Pilot 2 application. Therefore, the agency estimates that applicants use approximately 640 hours annually to submit the Pilot 2 applications. **Table 1.—Estimated Annual Reporting Burden** 1 Pilot 2 Application No. of Respondents No. of Responses per Response Total Responses Hours per Response Total Hours CDER 7 1 7 80 560 CBER 1 1 1 80 80 Total 640 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: July 17, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-11643 Filed 7-21-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N-0486] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Public Health Notification (formerly known as Safety Alert/Public Health Advisory) Readership Survey 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

(CDRH)communicates these risks to user communities through two publications:

(1)The Public Health Notification

(PHN)and

(2)the Preliminary Public Health Notification (PPHN). The PHN is published when CDRH has information or a message to convey to health care practitioners that they would want to know in order to make informed clinical decisions about the use of a device or device type, and that information may not be readily available to the affected target audience in the health care community, and CDRH can make recommendations that will help the health care practitioner mitigate or avoid the risk. The PPHN is also published when CDRH has information to convey to health care practitioners that they would want to know in order to make informed clinical decisions about the use of a device or device type. However, two additional conditions exist that make the use of this type of notification preferable. First, CDRH's understanding of the problem, its cause(s), and the scope of the risk is still evolving, and in order to minimize the risk, the center believes that health care practitioners need the information they have, however incomplete, as soon as possible. Second, the problem is being actively investigated by the center, the industry, another agency, or some other reliable entity, so that the center expects to be able to update the PPHN when definitive new information becomes available. Notifications are sent to organizations affected by the risks discussed in the notification, such as hospitals, nursing homes, hospices, home health care agencies, retail pharmacies, and other health care providers. Through a process for identifying and addressing postmarket safety issues related to regulated products, CDRH determines when to publish notifications. Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 300u(a)(4)) authorizes FDA to conduct research relating to health information. FDA seeks to evaluate the clarity, timeliness, and impact of safety alerts and public health advisories by surveying a sample of recipients. Subjects will receive a questionnaire to be completed and returned to FDA. The information to be collected will address how clearly notifications for reducing risk are explained, the timeliness of the information, and whether the reader has taken any action to eliminate or reduce risk as a result of information in the alert. Subjects will also be asked whether they wish to receive future notifications electronically, as well as how the PHN program might be improved. The information collected will be used to shape FDA's editorial policy for the PHN and PPHN. Understanding how target audiences view these publications will aid in deciding what changes should be considered in their content, format, and method of dissemination. In the **Federal Register** of December 22,2005 (70 FR 76054), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received in response to that notice. 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 308 3 924 .17 157 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Based on the history of the PHN program, it is estimated that an average of three collections will be conducted a year. The total burden of response time is estimated at 10 minutes per survey. This was derived by CDRH staff completing the survey and through discussions with the contacts in trade organizations. Dated: July 17, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-11644 Filed 7-21-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HOMELAND SECURITY Bureau of Customs and Border Protection [USCBP-2006-0021] Standards for Tariff Classification of Unisex Footwear AGENCY: Customs and Border Protection; Department of Homeland Security. ACTION: Proposed interpretation; solicitation of comments. SUMMARY: This document proposes new criteria to be used by the Bureau of Customs and Border Protection (“CBP”) to determine whether footwear should be considered to be “commonly worn by both sexes” (unisex) for tariff classification purposes under the Harmonized Tariff Schedule of the United States. The rates of duty applicable to footwear “For other persons” ( *i.e.* “unisex”) are about 1.5 percent higher than the rates of duty applicable to footwear “For men, youths and boys”. CBP is seeking comments from the public on its proposed criteria prior to adoption of a final interpretation. DATES: Comments must be received on or before September 22, 2006. FOR FURTHER INFORMATION CONTACT: Brian Barulich, Tariff Classification and Marking Branch, Office of Regulations and Rulings,

(202)572-8883. ADDRESSES: You may submit comments, identified by *docket number* , by *one* of the following methods: • Federal eRulemaking Portal: *http://www.regulations.gov.* Follow the instructions for submitting comments via docket number USCBP-2006-0021. • Mail: Trade and Commercial Regulations Branch, Office of Regulations and Rulings, Bureau of Customs and Border Protection, 1300 Pennsylvania Avenue, NW., (Mint Annex), Washington, DC 20229. *Instructions:* All submissions received must include the agency name and docket number for this document. All comments received will be posted without change to *http://www.regulations.gov* , including any personal information provided. For detailed instructions on submitting comments and additional information, see the “Public Participation” heading of the SUPPLEMENTARY INFORMATION section of this document. *Docket:* For access to the docket to read background documents or comments received go to *http://www.regulations.gov.* Submitted comments may also be inspected during regular business days between the hours of 9 a.m. and 4:30 p.m. at the Office of Regulations and Rulings, Bureau of Customs and Border Protection, 799 9th Street, NW., 5th Floor, Washington, DC. Arrangements to inspect submitted comments should be made in advance by calling Mr. Joseph Clark at

(202)572-8768. SUPPLEMENTARY INFORMATION: Public Participation Interested persons are invited to submit written data, views, or arguments on all aspects of the proposed interpretation. CBP also invites comments that relate to the economic, environmental, or federalism effects that might result from this proposed interpretation. Comments that will provide the most assistance to CBP in developing these procedures will reference a specific portion of the proposed interpretation, explain the reason for any recommended change, and include data, information, or authority that support such recommended change. Background This document sets forth CBP's proposed standards for classification of certain footwear as “unisex”. On April 15, 2002, CBP's predecessor, the U.S. Customs Service (hereinafter “CBP”, for clarity and consistency), published in the **Federal Register** (67 FR 18303) a general notice to solicit comments concerning alternatives to CBP's treatment of footwear deemed to be “unisex.” Four comments were received in response to that notice. In this document, CBP addresses the concerns and suggestions raised in those comments and proposes standards for determining whether footwear should be classified as unisex footwear. This document solicits further comment on the proposed interpretation before a final interpretation is published. Current Law and Policy Chapter 64 of the Harmonized Tariff Schedule of the United States (HTSUS) covers footwear, gaiters and the like, and parts of such articles. Disparities in the duty rates applicable to some provisions under heading 6403 in Chapter 64 are based on the gender of the user. Additional U.S. Note 1(b) and Statistical Note 1(b) to Chapter 64, HTSUS, provide that footwear “for men, youths and boys” covers footwear of certain men's and youths” sizes, but does not cover footwear commonly worn by both sexes (i.e., unisex footwear). Statistical Note 1(c) to Chapter 64, HTSUS, provides that footwear “for women” covers footwear of certain women's sizes, whether for females or of types commonly worn by both sexes (i.e, unisex). Elsewhere in the HTSUS (in subheadings 6403.99.75 and 6403.99.90, for example), footwear is classified as “for other persons,” a definition that also includes unisex footwear. The determination of whether footwear is classifiable as “for men, youths and boys” rather than “for women” or “for other persons,” therefore, often rests on whether the footwear is truly for men, youths and boys or is, in fact, unisex. The rates of duty applicable to footwear “For other persons” ( *i.e.* “unisex”) are about 1.5 percent higher than the rates applicable to footwear “For men, youths and boys”. It is noted that quota/visa requirements remain inapplicable to footwear. Many types of footwear may be, and in fact are, worn by both sexes. Moreover, many types of shoes in male sizes feature no physical characteristics that distinguish the footwear as being exclusively for males. Current CBP standards for making the determination of whether or not footwear is unisex have been developed and applied by CBP on an ad hoc, case-by-case basis. This approach to the “unisex” footwear issue, while effective in individual cases, has provided only limited guidance to the importing community and to CBP officers with respect to other prospective or current import transactions that present different factual patterns involving that issue. CBP's current approach to unisex determinations is as follows: CBP considers certain types or categories of footwear to at least be susceptible to unisex treatment (that is, to be classifiable as footwear “for other persons” despite claims that the footwear is designed and intended solely “for men, youths and boys”). These types of footwear include hikers, sandals, work boots, cowboy boots, combat boots, motorcycle boots, “athleizure” shoes, boat shoes, and various types within the class described as athletic footwear ( *e.g.* , tennis shoes and training shoes). CBP generally considers that a type of footwear is “commonly worn by both sexes” if the number of styles claimed to be for males in an importer's line, when compared to the number of styles in the line for females, renders it likely that females will purchase and wear at least 5 percent of the styles claimed to be for males. Once it is determined that an imported line of footwear potentially susceptible to unisex treatment is in fact “commonly worn by both sexes,” CBP applies unisex treatment to that footwear line only in sizes up to and including American men's size 8. However, if a shoe in an imported line claimed to be for males is of a type of footwear commonly worn by both sexes, CBP does not accord unisex treatment to the imported line if a “comparable line” of styles is available to females. To be considered a “comparable line,” CBP requires an equal number of styles of a particular type of footwear ( *i.e.* , a one-to-one ratio, female-to-male is required). In addition, to be considered a “comparable line,” female styles must be substantially similar to the styles for males in general appearance, value, marketing, activity for which designed, and component material (including percentage) breakdowns. For purposes of establishing the existence of a “comparable line” for females, CBP confines its determination to the imported footwear at issue. CBP may take notice of additional styles made available by the importer that are not included in a particular entry. CBP does not, however, consider the availability of comparable styles for females in the U.S. market as a whole. Finally, CBP does not consider the fact that a certain shoe is not marketed to women to be evidence that the shoe is not “commonly worn by both sexes.” Request From Public to Provide Enhanced Guidance In a letter dated September 17, 1999, the importing public, represented by the Footwear Distributors and Retailers of America (“FDRA”), requested that CBP take steps to provide enhanced guidance in determinations concerning “unisex” issues. The FDRA requested that CBP

(1)set forth criteria for determining whether footwear claimed to be “for men, youths and boys” is “commonly worn by both sexes” and therefore should be classified as footwear “for other persons” and

(2)ensure the uniform interpretation and application of those criteria by Customs field offices. Preliminary Notice After receiving the FDRA letter, CBP published a document in the **Federal Register** (67 FR 18303) on April 15, 2002. In that document, CBP set forth a more in depth analysis of its current procedures, and also set forth FDRA's proposed criteria. CBP solicited comments on the appropriateness of the specific standards suggested by FDRA and on the extent to which any standards followed by CBP in the past should be retained. Suggestions for alternative appropriate standards were also invited. Summary of Comments All four of the commenters who responded to the general notice provided a range of specific comments on various aspects of the “unisex” footwear issue. These comments are discussed below. *Comment:* All of the commenters take issue with the fact that CBP confines its “unisex” footwear determinations in every case to the footwear of a particular importer's line. They argue that CBP should consider the availability of comparable styles for females in the U.S. retail market to constitute, or substitute for, any part of the importer's “comparable line” for females. The commenters note that this narrow focus leads to inaccurate findings that an importer's footwear for males is “commonly worn by both sexes” ( *i.e.* , unisex). The commenters point out that the precise question raised by Additional U.S. Note 1(b) to chapter 64, is whether footwear is “commonly worn by both sexes.” They maintain that CBP improperly applies this statutory standard of “use” through presumptions, essentially basing factual determinations on:

(1)The size and type of shoe; and

(2)the number of various styles (male and/or female) included in an importer's line of merchandise. Two of the commenters concede that in most cases, confining the inquiry to the importer's line of footwear provides a reliable estimate as to whether footwear for males is commonly worn by both sexes. This is particularly true when the importer is a “branded distributor” of the footwear it imports, as opposed to a “non-branded importer,” who provides footwear to a retailer under the retailer's brand or a generic brand. However, the commenters assert that, in the case of the non-branded importer, confining the “unisex” determination to the importer's line of footwear not only provides an unreliable estimate as to whether footwear for males is commonly worn by both sexes, but also results in the misclassification of footwear. *CBP Response:* CBP agrees and, in an effort to bring more consistency to this area, is proposing to consider evidence from an importer of men's footwear demonstrating that it imports the same shoe for women and girls or that the same shoe for women and girls is imported by a separate importer and is available in the U.S. marketplace. *Comment:* All of the commenters stress that, in certain cases, importers must be allowed the opportunity to present evidence to establish that their footwear for males is not commonly worn by both sexes. One commenter cites to Treasury Decision (T.D.) 93-88, dated October 25, 1993, as an example of CBP's use of presumption in applying the above statutory standard. In T.D. 93-88, certain footwear definitions were provided for use as guidelines by the importing community. Under the term “unisex,” it stated, in part, that “[u]nless there is evidence to the contrary, assume all athletic shoes for youths (approximately sizes 11.5 to 2) and men, sizes 8 and smaller, are unisex except shoes for football, boxing or wrestling.” In addition, T.D. 93-88 indicates that CBP will not assume that certain shoes are unisex if there is “evidence to the contrary.” The commenter complains that CBP provides very little guidance to the importing community as to the type or amount of evidence needed to refute unreasonable presumptions. *CBP Response:* CBP agrees and is proposing to consider evidence of marketing provided by importers and others, and the marking of gender and size. By considering this evidence, CBP hopes to limit determinations that are based solely on presumption as to how footwear will be used. *Comment:* One commenter notes that CBP has previously ascertained the availability of women's styles and sizes in the retail market, to determine whether shoes claimed to be “for men, youths and boys” were classifiable as footwear “for other persons.” The commenter asserts that in Headquarters Ruling Letter

(HQ)955960, issued August 19, 1994, CBP determined that certain basketball shoes were classified as unisex because “retailers, as well as administrative staff members of a major college women's basketball team, stated that women will buy men's basketball shoes when a suitable selection is not available in the women's department.” The commenter opines that such an approach, based on available evidence, is sensible and correct. The commenter further notes that in HQ 952097 (issued September 15, 1992), CBP concluded that certain soccer shoes were classified as unisex based on informal interviews with retailers. *CBP Response:* As indicated above, CBP agrees with the commenter and is proposing to consider evidence of marketing provided by importers and others, as well as the marking of gender and size. *Comment:* Another commenter suggests that, regardless of the type of evidence CBP decides to require or accept, the agency should not have to perform its own market research, as it apparently did before issuing HQ 962742, dated February 28, 2001. This ruling concerned the extent of use by men of certain types of western/cowboy hats. To determine such use, CBP viewed numerous magazines, contacted several equine sports associations that regulate equine sports events for western style riding, and visited eight western stores. The commenter asserts that the judicial decisions and statutory standards pertinent to unisex footwear do not require the amount of extraneous evidence and number of subjective determinations inherent in standards utilized by CBP and in those initially proposed by the FDRA. The commenter maintains that reliance on the general appearance of footwear is extremely subjective, that shoes of identical construction often are not sold at similar prices and that susceptibility to use, likelihood of use, and availability of “comparable” styles in a retail market of ever-changing styles, tastes, etc., rarely shed light on the question of what is “commonly worn by both sexes.” However, the commenter also notes that in *Mast Industries, Inc.* v. *United States,* 9 C.I.T. 549 (1985), aff'd 786 F.2d 1144 (Fed. Cir. 1986), the court emphasized the primary importance of the characteristics of the imported merchandise, observing that “[t]he former Court of Customs and Patent Appeals held that the merchandise itself may be strong evidence of use.” *CBP Response:* CBP agrees with the court in Mast. Again, as indicated above, CBP is proposing to consider evidence of marketing provided by importers and others, and marking of gender and size in order to limit determinations that are based solely on presumption. CBP proposes to initially rely on evidence provided by the importer and others. However, CBP does not propose to limit its ability to perform market research in those cases where it finds such research necessary. *Comment:* One commenter, noting the judicial guidance of Mast discussed above, proposes that CBP base its unisex determinations on examination of:

(1)The imported merchandise itself; and

(2)the documents presented at the time the entry summary, or its equivalent, is filed. The commenter asserts that men's/boys' shoes are usually made on men's/boys' lasts ( *i.e.* , a block or form shaped like a human foot and used in making shoes) and are usually described as men's/boys' shoes on purchase orders, invoices and footwear detail sheets. The commenter suggests that, in order to eliminate any gender ambiguity, shoes for males could be labeled or marked to identify the gender for which the shoes have been designed, and to whom they will be marketed. CBP could require that such labeling or marking be visible in or on the shoe, the shoebox, or both. As an example, the commenter proposes requiring that a sewn-in label or hang tag state “boys size 6” instead of only “size 6,” in order to clarify that the shoe is a boy's shoe and that the importer intends that it be sold for use by boys. The commenter stresses that footwear described as men's/boys' shoes on the import documentation and marked as such, should be presumed to be marketed for sale to men and boys and should not be considered unisex. The commenter also states that shoes designed for males are usually merchandised separately from shoes for females, and even if sold in the same department of the same retail store, the shoes for each gender are usually segregated in separate areas, shelves or racks. The commenter contends that this aspect of marketing is a reflection of shoe design, because shoes for males are intended to be sold to males. The same commenter recommends the following “bright-line test” to establish what is commonly worn by both sexes. The following criteria should be met in order for CBP to presume that imported footwear is unisex. The footwear should be:

(a)American men's sizes 8 or under;

(b)a type that is susceptible to use by both sexes;

(c)not described in import documents as footwear for men, youths or boys; and

(d)not made on lasts designed for American males; or not marked, labeled, or sold as footwear for men, youths or boys by sizing or otherwise. The commenter also maintains, however, that an importer should be allowed to rebut CBP's presumption that the footwear is unisex, by establishing the existence of at least one comparable female shoe style, in either the importer's line or in the U.S. market, for every five male shoe styles, with comparability based solely on design and construction of the footwear. A failure to rebut the unisex presumption would call into effect the criterion identified by the commenter as: “(e) limited availability of comparable female styles.” *CBP Response:* CBP agrees in part and is proposing to base “unisex” determinations on examination of the imported merchandise and to accept evidence in the form of marketing material, retail advertisements, or other convincing documentation showing that the same shoe is available for “other persons” in the U.S. marketplace. CBP is proposing to generally accept presentation of such evidence as satisfactorily demonstrating that the instant footwear is exclusively for “men, youths and boys.” CBP is proposing to generally consider the marking of gender and size, to indicate men's size, youths' size, or boys' size, as acceptable evidence that a shoe is not “unisex.” CBP does not agree that import documents describing footwear as being for men, youths or boys should constitute sufficient evidence that the footwear is not commonly worn by both sexes. Lastly, the commenter offered no evidence to support the position that footwear made on male lasts is not commonly worn by both sexes. In the absence of such evidence, CBP declines to adopt that position. *Comment:* With respect to factors used to determine that a female style is comparable to a male style, one commenter (as noted immediately above) asserts that comparability should be based only on a shoe's design and construction. Two commenters maintain that comparability should be based primarily on a shoe's retail price, but also on the features and the materials that comprise its upper and outer sole. One of these two commenters also considers the type of shoe to be a factor of comparability. *CBP Response:* CBP agrees and is proposing to limit the “unisex” determination to the characteristics of the shoe under consideration, in most cases making comparisons and presumptions unnecessary. *Comment:* Concerning the ratio of female-to-male styles that could establish the existence of a “comparable line” for females, three commenters maintain that the existence of at least one comparable female style (in either the importer's line, or in the U.S. market) for every five male styles (a one-to-five ratio) should be deemed sufficient. These same commenters also state that a one-to-three ratio (female-to-male styles), as an alternative standard, could be considered sufficient. *CBP Response:* CBP disagrees that either a one-to-five or one-to-three ratio, female-to-male, is sufficient in the absence of the means and opportunity to examine and compare all styles of an importer's line. CBP is proposing, in the absence of marking as to gender, to require evidence that the same style of shoe for females is available in either the importer's line or the U.S. marketplace. CBP is not proposing to accept comparable styles as alternatives for the same style. *Comment:* With regard to any set percentage of use by (or sale to) females, of footwear claimed to be for males, indicative of footwear that is commonly worn by both sexes, one commenter suggests that 25 percent is an appropriate standard. The commenter contends that the 5 percent (one sale in twenty) standard utilized by CBP (subsequent to the court's finding in *De Vahni International, Inc.* v. *United States* , 66 Cust. Ct. 239, C.D. 4196 (1971), that “[s]uch infrequent usage [characterized by one sale in a hundred] could hardly be considered common”) is appropriate only as an indicator of *de minimis* usage. *CBP Response:* CBP agrees that the 5 percent standard does not provide an accurate indication that footwear is commonly worn by both sexes and is proposing to adopt a 25 percent standard. *Comment:* Concerning whether CBP should attempt to clarify, refine, and/or redefine terms such as “category,” “type,” “style,” “line,” etc., as they relate to footwear, one commenter recommends that all such terms be left alone. The commenter notes that these terms have been expressed by CBP in appropriately broad terms, that fashion drives most aspects of the footwear industry, and that the market concepts are so fluid that any narrow definitions would soon be obsolete. *CBP Response:* CBP agrees and is not proposing, at this time, to attempt to clarify, refine, or redefine footwear-related terms such as those stated above. *Comment:* With regard to whether unisex standards should be limited only to provisions under heading 6403, HTSUS, one commenter opines that the standards should indeed be limited to that heading. The commenter notes that in the other headings covering footwear, gender is addressed only at the statistical level ( *i.e.* , the ten digit level), and stated as “For men,” “For women,” or “Other,” in contrast to eight digit subheadings under heading 6403, which reference footwear “For men, youths or boys” and “For other persons.” The commenter also notes that in January 2000, many references to gender at the statistical level in heading 6403 ( *e.g.* , “misses,” “children,” and “infants”) were eliminated. *CBP Response:* CBP agrees and is proposing that unisex standards should be limited only to classifications within heading 6403, HTSUS. CBP's Proposed Criteria Based upon the comments received and for the reasons set forth above, CBP is proposing the following criteria for its determination of whether footwear should be deemed to be “unisex” under heading 6403, HTSUS:

(1)Footwear in sizes for men, youths or boys will not be considered to be “commonly worn by both sexes” ( *i.e.* , “unisex”) if marked “MEN'S SIZE__”, “YOUTHS' SIZE__”, or “BOYS' SIZE__”.

(2)Even if not marked as described in criterion 1, footwear in sizes for men, youths or boys will not be considered to be “commonly worn by both sexes” ( *i.e.* , “unisex”) if: a. The importer imports the same shoe for women and girls, or; b. Evidence is provided in the form of marketing material, retail advertisements, or other convincing documentation demonstrating that the same shoe for women and girls is available in the U.S. marketplace.

(3)A style of footwear in sizes for males will not be presumed to be “commonly worn by both sexes” ( *i.e.* , “unisex”) unless evidence of marketing establishes that at least one pair in four (25 percent) of that style is sold to and/or worn by females.

(4)A determination that footwear is “commonly worn by both sexes” will trigger “unisex” classification treatment that is applicable to all sizes. Dated: June 23, 2006. Deborah J. Spero, Acting Commissioner, Customs and Border Protection. [FR Doc. E6-11679 Filed 7-21-06; 8:45 am] BILLING CODE 9111-14-P DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5043-N-06] Notice of Proposed Information Collection for Public Comment: Survey of Manufactured (Mobile) Home Placements AGENCY: Office of Policy Development and Research, HUD. ACTION: Notice. SUMMARY: The proposed information collection requirement described below will be submitted to the Office of Management and Budget

(OMB)for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal. DATES: *Comments Due Date:* September 22, 2006. ADDRESSES: Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: Reports Liaison Officer, Office of Policy Development and Research, Department of Housing and Urban Development, 451 7th Street, SW., Room 8226, Washington, DC 20410. FOR FURTHER INFORMATION CONTACT: Robert A. Knight, Department of Housing and Urban Development, 451 7th Street, SW., Washington, DC 20410; telephone

(202)708-1060, Ext. 5893 (this is not a toll-free number), (or via the Internet at *Robert_A._Knight@hud.gov* ) or Michael Davis, U.S. Census Bureau, Manufacturing and Construction Division, Room 2126, FOB 4, Washington, DC 20233-6900, at

(301)763-1605 (or via the Internet at *Michael.Davis@census.gov* . SUPPLEMENTARY INFORMATION: The Department will submit the proposed information collection to OMB for review, as required by the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35, as amended). This Notice is soliciting comments from members of the public and affected agencies concerning the proposed collection of information to:

(1)Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(2)Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information;

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

(4)Minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology that will reduce respondent burden ( *e.g.,* permitting electronic submission of responses.) This Notice is requesting a revision of a currently approved collection. This Notice also lists the following information: *Title of Proposal:* Survey of Manufactured (Mobile) Home Placements. *OMB Control Number:* 2528-0029. *Description of the need for the information and proposed use:* The Survey of Manufactured (Mobile) Home Placements collects data on the characteristics of newly manufactured homes placed for residential use including number, sales price, location, and other selected characteristics. HUD uses the statistics to respond to a Congressional mandate in the Housing and Community Development Act of 1980, 42 U.S.C. 5424 note, which requires HUD to collect and report manufactured home sales and price information for the nation, census regions, states, and selected metropolitan areas and to monitor whether new manufactured homes are being placed on owned rather than rented lots. HUD also used these data to monitor total housing production and its affordability. *Agency Form Numbers:* C-MH-9A. *Members of Affected Public:* Business firms or other for-profit institutions. *Estimation of the Total Numbers of Hours Needed To Prepare the Information Collection Including Number of Respondents, Frequency of Response, and Hours of Response:* *Number of Respondents:* 7,300. *Estimate Responses per Respondent:* 2. *Time per Respondent:* 30 minutes. *Total Hours To Respond:* 3,650. *Respondent's Obligation:* Voluntary. *Status of the Proposed Information Collection:* Pending OMB approval. Authority: Title 42 U.S.C. 5424 note, Title 13 U.S.C. Section 8(b), and Title 12, U.S.C., Section 1701z-1. Dated: July 17, 2006. Darlene F. Williams, Assistant Secretary for Policy, Development and Research. [FR Doc. 06-6432 Filed 7-21-06; 8:45 am]

Connectionstraces to 12

Traces to 12 documents

U.S. Code