Agency Information Collection Activities; Submission for OMB Review; Comment Request, 75461-75465 [E5-7531]

Download as PDF Federal Register / Vol. 70, No. 243 / Tuesday, December 20, 2005 / Notices Rasco Trust, DeWitt, Arkansas (Nancy Ferguson Rasco and DeWitt Bank & Trust as co-trustees); the Rebecca F. Ehrlicher Trust, DeWitt, Arkansas (Rebecca Ferguson Ehrlicher and DeWitt Bank & Trust as co–trustees); the Charles W. Rasco III Marital Trust (DeWitt Bank & Trust as trustee); and the Elmer Ferguson Farms, Inc., DeWitt, Arkansas; to retain voting shares of DBT Financial Corporation, DeWitt, Arkansas, and thereby indirectly acquire additional voting shares of DeWitt Bank and Trust Company, DeWitt, Arkansas. Board of Governors of the Federal Reserve System, December 15, 2005. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E5–7555 Filed 12–19–05; 8:45 am] BILLING CODE 6210–01–S FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies; Correction This notice corrects a notice (FR Doc. E5-7262) published on page 73747 of the issue for Tuesda, December 13, 2005. Under the Federal Reserve Bank of New York heading, the entry for Community Partners Bancorp, Middletown, New Jersey, is revised to read as follows: A. Federal Reserve Bank of New York (Jay Bernstein, Bank Supervision Officer) 33 Liberty Street, New York, New York 10045-0001: 1. Community Partners Bancorp, Middletown, New Jersey; to become a bank holding company by acquiring 100 percent of the voting shares of Two River Community Bank, Middletown, New Jersey, and The Town Bank, Westfield, New Jersey. Comments on this application must be received by January 6, 2006. Board of Governors of the Federal Reserve System, December 15, 2005. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E5–7556 Filed 12–19–05; 8:45 am] BILLING CODE 6210–01–S SUMMARY: The information collection requirements described below will be submitted to the Office of Management and Budget (‘‘OMB’’) for review, as required by the Paperwork Reduction Act (‘‘PRA’’) (44 U.S.C. 3501–3520). The FTC is seeking public comments on its proposal to extend through December 31, 2008 the current PRA clearances for information collection requirements contained in four product labeling rules enforced by the Commission. Those clearances expire on December 31, 2005. DATES: Comments must be received on or before January 19, 2006. ADDRESSES: Interested parties are invited to submit written comments. Comments should refer to ‘‘Apparel Rules: FTC File No. P948404’’ to facilitate the organization of comments. A comment filed in paper form should include this reference both in the text and on the envelope and should be mailed or delivered, with two complete copies, to the following address: Federal Trade Commission/Office of the Secretary, Room H–135 (Annex J), 600 Pennsylvania Avenue, NW., Washington, DC 20580. Because paper mail in the Washington area and at the Commission is subject to delay, please consider submitting your comments in electronic form, (in ASCII format, WordPerfect, or Microsoft Word) as part of or as an attachment to email messages directed to the following email box: paperworkcomment@ftc.gov. However, if the comment contains any material for which confidential treatment is requested, it must be filed in paper form, and the first page of the document must be clearly labeled ‘‘Confidential.’’ 1 Comments should also be submitted to: Office of Management and Budget, Attention: Desk Officer for the Federal Trade Commission. Comments should be submitted via facsimile to (202) 395– 6974 because U.S. Postal Mail is subject to lengthy delays due to heightened security precautions. The FTC Act and other laws the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. All timely and responsive public comments will be considered by the Commission and will be available to the public on the FTC website, to the extent practicable, at https://www.ftc.gov. FEDERAL TRADE COMMISSION Agency Information Collection Activities; Submission for OMB Review; Comment Request Federal Trade Commission (‘‘FTC’’ or ‘‘Commission’’). ACTION: Notice. AGENCY: VerDate Aug<31>2005 19:23 Dec 19, 2005 Jkt 208001 1 Commission Rule 4.2(d), 16 CFR 4.2(d). The comment must be accompanied by an explicit request for confidential treatment, including the factual and legal basis for the request, and must identify the specific portions of the comment to be withheld from the public record. The request will be granted or denied by the Commission’s General Counsel, consistent with applicable law and the public interest. See Commission Rule 4.9(c), 16 CFR 4.9(c). PO 00000 Frm 00017 Fmt 4703 Sfmt 4703 75461 As a matter of discretion, the FTC makes every effort to remove home contact information for individuals from the public comments it receives before placing those comments on the FTC Web site. More information, including routine uses permitted by the Privacy Act, may be found in the FTC’s privacy policy at https://www.ftc.gov/ftc/ privacy.htm. FOR FURTHER INFORMATION CONTACT: Requests for additional information or copies of the proposed information requirements should be addressed as follows: For the Fur Act Regulations, Wool Act Regulations, and Textile Act Regulations, contact Carol Jennings, Attorney, Enforcement Division, Bureau of Consumer Protection 600 Pennsylvania Ave., NW., Washington, DC 20580, (202) 326–2996. For the Care Labeling Rule, contact Connie Vecellio, Attorney, Enforcement Division, Bureau of Consumer Protection, 600 Pennsylvania Ave., NW., Washington, DC 20580, (202) 326–2996. SUPPLEMENTARY INFORMATION: On September 28, 2005, the FTC sought comment on the information collection requirements associated with regulations under the Fur Act, 16 CFR Part 301 (OMB Control Number 3084– 0099); regulations under the Wool Act, 16 CFR Part 300 (OMB Control Number 3084–0100); regulations under the Textile Act, 16 CFR Part 303 (OMB Control Number 3084–0101); and the Care Labeling Rule, 16 CFR 423 (OMB Control Number 3084–0103). See 70 FR 56692. No comments were received. Pursuant to the OMB regulations that implement the PRA (5 CFR Part 1320), the FTC is providing this second opportunity for public comment while seeking OMB approval to extend the existing paperwork clearance for the rules. All comments should be filed as prescribed in the ADDRESSES section above, and must be received on or before January 19, 2006. Staff’s burden estimates for the four rules in question are based on data from the Bureau of Census, U.S. Customs and International Trade Commission, the Department of Labor, and data or other input from industry sources. The relevant information collection requirements within these rules and corresponding burden estimates follow. 1. Regulations Under the Fur Products Labeling Act, 15 U.S.C. 69 et seq. (‘‘Fur Act’’), 16 CFR Part 301 (OMB Control Number: 3084–0099) The Fur Act prohibits the misbranding and false advertising of fur products. The Fur Act Regulations, 16 E:\FR\FM\20DEN1.SGM 20DEN1 75462 Federal Register / Vol. 70, No. 243 / Tuesday, December 20, 2005 / Notices CFR 301, establish disclosure requirements that assist consumers in making informed purchasing decisions, and recordkeeping requirements that assist the Commission in enforcing these regulations. The Regulations also provide a procedure for exemption from certain disclosure provisions under the Fur Act. Estimated annual hours burden: 168,000 hours, rounded to the nearest thousand (54,080 hours for recordkeeping + 113,633 hours for disclosure). Recordkeeping: The Regulations require that retailers, manufacturers, processors, and importers of furs and fur products keep certain records in addition to those they may keep in the ordinary course of business. Staff estimates that 1,300 retailers incur an average recordkeeping burden of about 13 hours per year (16,900 hours total); 115 manufacturers and fur processors combined incur an average recordkeeping burden of about 52 hours per year (5,980 total); and 1,200 importers of furs and fur products incur an average recordkeeping burden of 26 hours per year (31,200 hours total). The combined recordkeeping burden for the industry is approximately 54,080 hours annually. Disclosure: Staff estimates that 1,400 respondents (100 manufacturers + 1,300 retail sellers of fur garments) each require an average of 20 hours per year to determine label content (28,000 hours total), and an average of five hours per year to draft and order labels (7,000 hours total). Staff estimates that the total number of garments subject to the fur labeling requirements is approximately 3,000,000.2 Staff estimates that for approximately half of these garments, labels are attached manually, requiring approximately two minutes per garment for a total of 50,000 hours annually. For the remaining 1,500,000, the process of attaching labels is semi-automated and requires an average of approximately two seconds per item, for a total of 1,000 hours (rounded to the nearest thousand). Thus, the total burden for attaching labels is 51,000 hours, and the total burden for labeling garments is 86,000 hours per year. Staff estimates that the incremental burden associated with the Regulations’ invoice disclosure requirement, beyond Task the time that would be devoted to preparing invoices in its absence, is approximately 30 seconds per invoice.3 The invoice disclosure requirement applies to fur garments, which are generally sold individually, and fur pelts, which are generally sold in groups of at least 50, on average. Assuming invoices are prepared for sales of 3,000,000 garments and 160,000 groups (an estimated 8 million pelts ÷ 50) each of imported and domestic pelts, the invoice disclosure requirement entails an estimated total burden of 26,333 hours. Staff estimates that the Regulations’ advertising disclosure requirements impose an average burden of one hour per year for each of the approximately 1,300 domestic fur retailers, or a total of 1,300 hours. Thus, staff estimates the total disclosure burden to be approximately 113,633 hours (86,000 hours for labeling + 26,333 hours for invoices + 1,300 hours for advertising). Estimated annual cost burden: $2,153,000, rounded to the nearest thousand (solely relating to labor costs). Hourly rate Burden hours Labor cost Determine label content ............................................................................................................... Draft and order labels .................................................................................................................. Attach labels ................................................................................................................................ Invoice disclosures ...................................................................................................................... Prepare advertising disclosures .................................................................................................. Recordkeeping ............................................................................................................................. $ 20.00 13.00 4 8.50 13.00 18.00 13.00 28,000 7,000 51,000 26,333 1,300 54,080 $560,000 91,000 433,500 342,329 23,400 703,040 Total ............................................................................................................................... ........................ ........................ 2,153,269 4 Per industry sources, most fur labeling is done in the U.S., and this rate is reflective of an average domestic hourly wage for such tasks. Conversely, attaching labels with regard to the others regulations discussed herein is mostly performed by foreign labor, as detailed in note 5. 2 The total number of fur garments, fur-trimmed garments, and fur accessories is estimated to be approximately 3,500,000, based on International Trade Commission data. Of that number, approximately 500,000 items are estimated to be VerDate Aug<31>2005 19:23 Dec 19, 2005 Jkt 208001 exempt from the labeling requirements pursuant to 16 CFR 301.39 (items where either the cost of the fur trim to the manufacturer or the manufacturer’s selling price for the finished product is less than $150 are exempt). PO 00000 Frm 00018 Fmt 4703 Sfmt 4703 3 The invoice disclosure burden for PRA purposes excludes the time that respondents would spend for invoicing, apart from the Fur Act Regulations, in the ordinary course of business. See 5 CFR 1320.3(b)(2). E:\FR\FM\20DEN1.SGM 20DEN1 Federal Register / Vol. 70, No. 243 / Tuesday, December 20, 2005 / Notices Staff believes that there are no current start-up costs or other capital costs associated with the Regulations. Because the labeling of fur products has been an integral part of the manufacturing process for decades, manufacturers have in place the capital equipment necessary to comply with the Regulations’ labeling requirements. Industry sources indicate that much of the information required by the Fur Act and its implementing Regulations would be included on the product label even absent the regulations. Similarly, invoicing, recordkeeping, and advertising disclosures are tasks performed in the ordinary course of business so that covered firms would incur no additional capital or other nonlabor costs as a result of the Act or the Regulations. 2. Regulations Under the Wool Products Labeling Act, 15 U.S.C. 68 et seq. (‘‘Wool Act’’), 16 CFR Part 300 (OMB Control Number: 3084–0100) The Wool Act prohibits the misbranding of wool products. The Wool Act Regulations, 16 CFR 300, establish disclosure requirements that assist consumers in making informed purchasing decisions and recordkeeping requirements that assist the Commission in enforcing the Regulations. Estimated annual hours burden: 407,000 hours, rounded to the nearest thousand (80,000 recordkeeping hours + 326,667 disclosure hours). Recordkeeping: Staff estimates that approximately 4,000 wool firms are subject to the Regulations’ recordkeeping requirements. Based on an average annual burden of 20 hours per firm, the total recordkeeping burden is 80,000 hours. Disclosure: Approximately 8,000 wool firms, producing or importing about 500,000,000 wool products annually, are subject to the Regulations’ Task 75463 disclosure requirements. Staff estimates the burden of determining label content to be 15 hours per year per respondent, or a total of 120,000 hours, and the burden of drafting and ordering labels to be 5 hours per respondent per year, or a total of 40,000 hours. Staff believes that the process of attaching labels is now fully automated and integrated into other production steps for about 40 percent of all affected products. For the remaining 300,000,000 items (60 percent of 500,000,000), the process is semi-automated and requires an average of approximately two seconds per item, for a total of 166,667 hours per year. Thus, the total estimated annual burden for all respondents is 326,667 hours. Staff believes that any additional burden associated with advertising disclosure requirements would be minimal (less than 10,000 hours) and can be subsumed within the burden estimates set forth above. Estimated annual cost burden: $4,460,000, rounded to the nearest thousand (solely relating to labor costs). Hourly rate Burden hours Labor cost Determine label content ............................................................................................................... Draft and order labels .................................................................................................................. Attach labels ................................................................................................................................ Recordkeeping ............................................................................................................................. $20.00 13.00 5 3.00 13.00 120,000 40,000 166,667 80,000 $2,400,000 520,000 500,001 1,040,000 Total ...................................................................................................................................... ........................ ........................ 4,460,001 5 For products that are imported, this work generally is done in the country where they are manufactured. According to information compiled by an industry trade association using data from the International Trade Commission, the U.S. Customs Service, and the U.S. Census Bureau, approximately 90% of apparel and other textile products used in the United States is imported. With the remaining 10% attributable to U.S. production at an approximate domestic hourly wage of $8.50 to attach labels, staff has calculated a weighted average hourly wage of $3 per hour attributable to U.S. and foreign labor combined. The estimated percentage of imports supplied by particular countries is based on trade data for 2001 compiled by the Office of Textiles and Apparel, International Trade Administration, U.S. Department of Commerce. Wages in major textile exporting countries, factored into the above hourly wage estimate, were based on data published in February 2000 by the U.S. Department of Labor, Bureau of International Labor Affairs (See ‘‘Wages, Benefits, Poverty Line, and Meeting Workers’’ Needs in the Apparel and Footwear Industries of Selected Countries,’’ Table I–2: ‘‘Prevailing or Average Wages in the Manufacturing Sector and in the Footwear and Apparel Industries in Selected Countries, Latest Available Year’’). Staff believes that there are no current start-up costs or other capital costs associated with the Regulations. Because the labeling of wool products has been an integral part of the manufacturing process for decades, manufacturers have in place the capital equipment necessary to comply with the Regulations. Based on knowledge of the industry, staff believes that much of the information required by the Wool Act and its implementing regulations would be included on the product label even absent their requirements. Similarly, recordkeeping and advertising disclosures are tasks performed in the ordinary course of business so that covered firms would incur no additional capital or other non-labor costs as a result of the Regulations. VerDate Aug<31>2005 19:23 Dec 19, 2005 Jkt 208001 3. Regulations Under the Textile Fiber Products Identification Act, 15 U.S.C. 70 et seq. (‘‘Textile Act’’), 16 CFR Part 303 (OMB Control Number: 3084–0101) The Textile Act prohibits the misbranding and false advertising of textile fiber products. The Textile Act Regulations, 16 CFR 303, establish disclosure requirements that assist consumers in making informed purchasing decisions, and recordkeeping requirements that assist the Commission in enforcing the Regulations. The Regulations also contain a petition procedure for requesting the establishment of generic names for textile fibers.5 Estimated annual hours burden: approximately 8,011,000 hours, rounded to the nearest thousand (600,000 recordkeeping hours + 7,411,111 disclosure hours). PO 00000 Frm 00019 Fmt 4703 Sfmt 4703 Recordkeeping: Staff estimates that approximately 24,000 textile firms are subject to the Textile Regulations’ recordkeeping requirements. Based on an average burden of 25 hours per firm, the total recordkeeping burden is 600,000 hours. Disclosure: Approximately 32,000 textile firms, producing or importing about 19.9 billion textile fiber products annually, are subject to the Regulations’ disclosure requirements.6 Staff 6 The apparent consumption of garments in the U.S. in 2004 was 18.4 billion. Staff estimates that 1 billion garments are exempt from the Textile Act (i.e., any kind of headwear and garments made from something other than a textile fiber product, such as leather) or are subject to a special exemption for hosiery products sold in packages where the label information is contained on the package. Based on available data, staff estimates that an additional 3 billion household textile products (non-garments, such as sheets, towels, blankets) were consumed. E:\FR\FM\20DEN1.SGM Continued 20DEN1 75464 Federal Register / Vol. 70, No. 243 / Tuesday, December 20, 2005 / Notices estimates the burden of determining label content to be 20 hours per year per respondent, or a total of 640,000 hours and the burden of drafting and ordering labels to be 5 hours per respondent per year, or a total of 160,000 hours. Staff believes that the process of attaching labels is now fully automated and integrated into other production steps for about 40 percent of all affected products. For the remaining 11.9 billion items (60 percent of 19.9 billion), the process is semi-automated and requires an average of approximately two seconds per item, for a total of 6,611,111 hours per year. Thus, the total estimated annual burden for all respondents is 7,411,111 hours. Staff believes that any Task additional burden associated with advertising disclosure requirements or the filing of generic fiber name petitions would be minimal (less than 10,000 hours) and can be subsumed within the burden estimates set forth above. Estimated annual cost burden: $42,513,000, rounded to the nearest thousand (solely relating to labor costs). Hourly rate Burden hours Labor cost Determine label content ............................................................................................................... Draft and order labels .................................................................................................................. Attach labels ................................................................................................................................ Recordkeeping ............................................................................................................................. $ 20.00 13.00 7 3.00 13.00 640,000 160,000 6,611,111 600,000 $12,800,000 2,080,000 19,833,333 7,800,000 Total ...................................................................................................................................... ........................ ........................ 42,513,333 7 See note 5. Staff believes that there are no current start-up costs or other capital costs associated with the Regulations. Because the labeling of textile products has been an integral part of the manufacturing process for decades, manufacturers have in place the capital equipment necessary to comply with the Regulations’ labeling requirements. Industry sources indicate that much of the information required by the Textile Act and its implementing rules would be included on the product label even absent their requirements. Similarly, recordkeeping, invoicing, and advertising disclosures are tasks performed in the ordinary course of business so that covered firms would incur no additional capital or other nonlabor costs as a result of the Regulations. 4. The Care Labeling Rule, 16 CFR Part 423 (OMB Control Number: 3084–0103) The Care Labeling Rule, 16 CFR Part 423, requires manufacturers and importers to attach a permanent care label to all covered textile clothing in order to assist consumers in making purchase decisions and in determining what method to use to clean their apparel. Also, manufacturers and importers of piece goods used to make textile clothing must provide the same care information on the end of each bolt or roll of fabric. Estimated annual hours burden: 6,889,000 hours, rounded to the nearest thousand (solely relating to disclosure 8). Staff estimates that approximately 24,700 manufacturers or importers of textile apparel, producing about 17.4 billion textile garments annually, are subject to the Rule’s disclosure requirements. The burden of developing proper care instructions may vary greatly among firms, primarily based on the number of different lines of textile garments introduced per year that require new or revised care instructions. Task Staff estimates the burden of determining care instructions to be 43 hours each year per respondent, for a cumulative total of 1,062,100 hours. Staff further estimates that the burden of drafting and ordering labels is 2 hours each year per respondent, for a total of 49,400 hours. Staff believes that the process of attaching labels is fully automated and integrated into other production steps for about 40 percent of the approximately 17.4 billion garments that are required to have care instructions on permanent labels.9 For the remaining 10.4 billion items (60 percent of 17.4 billion), the process is semi-automated and requires an average of approximately two seconds per item, for a total of 5,777,778 hours per year. Thus, the total estimated annual burden for all respondents is 6,889,278 hours. Estimated annual cost burden: $39,218,000, rounded to the nearest thousand (solely relating to labor costs). Hourly rate Burden hours Labor cost Determine care instructions ......................................................................................................... Draft and order labels .................................................................................................................. Attach labels ................................................................................................................................ $20.00 13.00 10 3.00 1,062,100 49,400 5,777,778 $21,242,000 642,200 17,333,334 Total ...................................................................................................................................... ........................ ........................ 39,217,534 10 See note 5. Staff believes that there are no current start-up costs or other capital costs associated with the Rule. Because the labeling of textile products has been an integral part of the manufacturing process for decades, manufacturers have in place the capital equipment necessary to comply with the Rule’s labeling requirements. Based on knowledge of the industry, staff believes that much of the information required by the Rule would be included on the However, approximately .5 billion of all of these combined products (garments and non-garments) are subject to the Wool Products Labeling Act, not the Textile Fiber Products Identification Act, because they contain some amount of wool. Thus, the estimated net total products subject to the Textile Fiber Products Identification Act is 19.9 billion. 8 The Care Labeling Rule imposes no specific recordkeeping requirements. Although the Rule requires manufacturers and importers to have reliable evidence to support the recommended care instructions, companies may provide as support current technical literature or rely on past experience. 9 About 1 billion of the 18.4 billion garments produced annually are either not covered by the Care Labeling Rule (gloves, hats, caps, and leather, fur, plastic, or leather garments) or are subject to an exemption that allows care instructions to appear on packaging (hosiery). VerDate Aug<31>2005 19:23 Dec 19, 2005 Jkt 208001 PO 00000 Frm 00020 Fmt 4703 Sfmt 4703 E:\FR\FM\20DEN1.SGM 20DEN1 Federal Register / Vol. 70, No. 243 / Tuesday, December 20, 2005 / Notices product label even absent those requirements. DEPARTMENT OF HEALTH AND HUMAN SERVICES William Blumenthal, General Counsel. [FR Doc. E5–7531 Filed 12–19–05; 8:45 am] Food and Drug Administration BILLING CODE 6750–01–P Notice of Approval of Supplemental New Animal Drug Application; Tilmicosin AGENCY: DEPARTMENT OF HEALTH AND HUMAN SERVICES ACTION: Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Occupational Health and Safety Research, Program Announcement 04038 and Small Grants in Occupational Safety and Health, Program Announcement 04021 In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC) announces the following meeting: Name: Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Occupational Health and Safety Research, Program Announcement 04038 and Small Grants in Occupational Safety and Health, Program Announcement 04021. Time and Date: 1 p.m.–3 p.m., January 13, 2006 (Closed). Place: National Institute for Occupational Safety and Health, CDC, 1600 Clifton Road, NE., Mailstop E–74, Atlanta, GA 30333 Telephone Number (404) 498–2582. Status: The meeting will be closed to the public in accordance with provisions set forth in section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92–463. Matters To Be Considered: The meeting will include the review, discussion, and evaluation of applications received in response to: Occupational Health and Safety Research, Program Announcement 04038 and Small Grants in Occupational Safety and Health, Program Announcement 04021. Contact Person For More Information: Charles Rafferty, Ph.D., Scientific Review Administrator, National Institute for Occupational Safety and Health, CDC, 1600 Clifton Road, NE., Mailstop E–74, Atlanta, GA 30333, Telephone Number (404) 498– 2582. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: December 13, 2005. Alvin Hall, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E5–7550 Filed 12–19–05; 8:45 am] BILLING CODE 4163–18–P VerDate Aug<31>2005 19:23 Dec 19, 2005 Jkt 208001 Food and Drug Administration, HHS. Notice. SUMMARY: The Food and Drug Administration (FDA) is providing notice that it has approved a supplemental new animal drug application (NADA) filed by Elanco Animal Health. The approved NADA provides for the veterinary prescription use of an injectable solution of tilmicosin phosphate for respiratory disease in cattle and sheep. This supplemental NADA adds user safety information to product labeling. FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for Veterinary Medicine (HFV–130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–7571, email: joan.gotthardt@fda.gov. SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a supplement to NADA 140–929 for MICOTIL 300 (tilmicosin phosphate), an injectable solution available by veterinary prescription for use in the treatment and control of respiratory disease in cattle and in the treatment of respiratory disease in sheep. This supplemental NADA adds user safety information to product labeling related to the mechanism of toxicity and medical intervention. In accordance with section 512(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360b(i)) and part 514 (21 CFR part 514) in §§ 514.105(a) and 514.106(a), the Center for Veterinary Medicine is providing notice that this supplemental NADA is approved as of December 2, 2005. The basis of approval is discussed in the freedom of information summary. In accordance with the freedom of information provisions of 21 CFR part 20 and § 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 75465 FDA has determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. Dated: December 8, 2005. Bernadette Dunham, Deputy Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 05–24269 Filed 12–19–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N–0485] Regulatory Process for Pediatric Mechanical Circulatory Support Devices (Ventricular Assist Devices) AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting. SUMMARY: The Food and Drug Administration (FDA) is announcing the following public meeting: Regulatory Process for Pediatric Mechanical Circulatory Support Devices (Ventricular Assist Devices). The topics of discussion are the agency’s activities regarding the regulation and approval of circulatory support devices used for temporary support in pediatric patients. Date and Time: The public meeting will be held on January 20, 2006, from 9 a.m. to 12 p.m. The agency is requiring registration by December 30, 2005. Location: The public meeting will be held at the Center for Devices and Radiological Health, rm. 20B, 9200 Corporate Blvd., Rockville, MD 20850. Contact: Eric Chen, Center for Devices and Radiological Health (HFZ–450), Food and Drug Administration, 9200 Corporate Blvd., 301–443–8262, ext. 146, e-mail: eac@cdrh.fda.gov, or Michael Berman (HFZ–170), 12725 Twinbrook Pkwy., 301–827–4744, email: mrb@cdrh.fda.gov. If you need special accommodations due to a disability, please contact Eric Chen, at least 7 days in advance of the meeting. Registration: There is no fee to attend the workshop; however, because space is limited, registration is required. Please submit registration information (including name, title, firm name, address, e-mail address, telephone number, and fax number) by December 30, 2005 (see Contact). Background information for the workshop will be E:\FR\FM\20DEN1.SGM 20DEN1

Agencies

FEDERAL TRADE COMMISSION

[Federal Register Volume 70, Number 243 (Tuesday, December 20, 2005)]
[Notices]
[Pages 75461-75465]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E5-7531]

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FEDERAL TRADE COMMISSION

Agency Information Collection Activities; Submission for OMB
Review; Comment Request

AGENCY: Federal Trade Commission (``FTC'' or ``Commission'').

ACTION: Notice.

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SUMMARY: The information collection requirements described below will
be submitted to the Office of Management and Budget (``OMB'') for
review, as required by the Paperwork Reduction Act (``PRA'') (44 U.S.C.
3501-3520). The FTC is seeking public comments on its proposal to
extend through December 31, 2008 the current PRA clearances for
information collection requirements contained in four product labeling
rules enforced by the Commission. Those clearances expire on December
31, 2005.

DATES: Comments must be received on or before January 19, 2006.

ADDRESSES: Interested parties are invited to submit written comments.
Comments should refer to ``Apparel Rules: FTC File No. P948404'' to
facilitate the organization of comments. A comment filed in paper form
should include this reference both in the text and on the envelope and
should be mailed or delivered, with two complete copies, to the
following address: Federal Trade Commission/Office of the Secretary,
Room H-135 (Annex J), 600 Pennsylvania Avenue, NW., Washington, DC
20580. Because paper mail in the Washington area and at the Commission
is subject to delay, please consider submitting your comments in
electronic form, (in ASCII format, WordPerfect, or Microsoft Word) as
part of or as an attachment to email messages directed to the following
email box: paperworkcomment@ftc.gov. However, if the comment contains
any material for which confidential treatment is requested, it must be
filed in paper form, and the first page of the document must be clearly
labeled ``Confidential.'' \1\
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\1\ Commission Rule 4.2(d), 16 CFR 4.2(d). The comment must be
accompanied by an explicit request for confidential treatment,
including the factual and legal basis for the request, and must
identify the specific portions of the comment to be withheld from
the public record. The request will be granted or denied by the
Commission's General Counsel, consistent with applicable law and the
public interest. See Commission Rule 4.9(c), 16 CFR 4.9(c).
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Comments should also be submitted to: Office of Management and
Budget, Attention: Desk Officer for the Federal Trade Commission.
Comments should be submitted via facsimile to (202) 395-6974 because
U.S. Postal Mail is subject to lengthy delays due to heightened
security precautions.
The FTC Act and other laws the Commission administers permit the
collection of public comments to consider and use in this proceeding as
appropriate. All timely and responsive public comments will be
considered by the Commission and will be available to the public on the
FTC website, to the extent practicable, at https://www.ftc.gov. As a
matter of discretion, the FTC makes every effort to remove home contact
information for individuals from the public comments it receives before
placing those comments on the FTC Web site. More information, including
routine uses permitted by the Privacy Act, may be found in the FTC's
privacy policy at https://www.ftc.gov/ftc/privacy.htm.

FOR FURTHER INFORMATION CONTACT: Requests for additional information or
copies of the proposed information requirements should be addressed as
follows:
For the Fur Act Regulations, Wool Act Regulations, and Textile Act
Regulations, contact Carol Jennings, Attorney, Enforcement Division,
Bureau of Consumer Protection 600 Pennsylvania Ave., NW., Washington,
DC 20580, (202) 326-2996.
For the Care Labeling Rule, contact Connie Vecellio, Attorney,
Enforcement Division, Bureau of Consumer Protection, 600 Pennsylvania
Ave., NW., Washington, DC 20580, (202) 326-2996.

SUPPLEMENTARY INFORMATION: On September 28, 2005, the FTC sought
comment on the information collection requirements associated with
regulations under the Fur Act, 16 CFR Part 301 (OMB Control Number
3084-0099); regulations under the Wool Act, 16 CFR Part 300 (OMB
Control Number 3084-0100); regulations under the Textile Act, 16 CFR
Part 303 (OMB Control Number 3084-0101); and the Care Labeling Rule, 16
CFR 423 (OMB Control Number 3084-0103). See 70 FR 56692. No comments
were received. Pursuant to the OMB regulations that implement the PRA
(5 CFR Part 1320), the FTC is providing this second opportunity for
public comment while seeking OMB approval to extend the existing
paperwork clearance for the rules. All comments should be filed as
prescribed in the ADDRESSES section above, and must be received on or
before January 19, 2006.
Staff's burden estimates for the four rules in question are based
on data from the Bureau of Census, U.S. Customs and International Trade
Commission, the Department of Labor, and data or other input from
industry sources. The relevant information collection requirements
within these rules and corresponding burden estimates follow.

1. Regulations Under the Fur Products Labeling Act, 15 U.S.C. 69 et
seq. (``Fur Act''), 16 CFR Part 301 (OMB Control Number: 3084-0099)

The Fur Act prohibits the misbranding and false advertising of fur
products. The Fur Act Regulations, 16

[[Page 75462]]

CFR 301, establish disclosure requirements that assist consumers in
making informed purchasing decisions, and recordkeeping requirements
that assist the Commission in enforcing these regulations. The
Regulations also provide a procedure for exemption from certain
disclosure provisions under the Fur Act.
Estimated annual hours burden: 168,000 hours, rounded to the
nearest thousand (54,080 hours for recordkeeping + 113,633 hours for
disclosure).
Recordkeeping: The Regulations require that retailers,
manufacturers, processors, and importers of furs and fur products keep
certain records in addition to those they may keep in the ordinary
course of business. Staff estimates that 1,300 retailers incur an
average recordkeeping burden of about 13 hours per year (16,900 hours
total); 115 manufacturers and fur processors combined incur an average
recordkeeping burden of about 52 hours per year (5,980 total); and
1,200 importers of furs and fur products incur an average recordkeeping
burden of 26 hours per year (31,200 hours total). The combined
recordkeeping burden for the industry is approximately 54,080 hours
annually.
Disclosure: Staff estimates that 1,400 respondents (100
manufacturers + 1,300 retail sellers of fur garments) each require an
average of 20 hours per year to determine label content (28,000 hours
total), and an average of five hours per year to draft and order labels
(7,000 hours total). Staff estimates that the total number of garments
subject to the fur labeling requirements is approximately 3,000,000.\2\
Staff estimates that for approximately half of these garments, labels
are attached manually, requiring approximately two minutes per garment
for a total of 50,000 hours annually. For the remaining 1,500,000, the
process of attaching labels is semi-automated and requires an average
of approximately two seconds per item, for a total of 1,000 hours
(rounded to the nearest thousand). Thus, the total burden for attaching
labels is 51,000 hours, and the total burden for labeling garments is
86,000 hours per year.
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\2\ The total number of fur garments, fur-trimmed garments, and
fur accessories is estimated to be approximately 3,500,000, based on
International Trade Commission data. Of that number, approximately
500,000 items are estimated to be exempt from the labeling
requirements pursuant to 16 CFR 301.39 (items where either the cost
of the fur trim to the manufacturer or the manufacturer's selling
price for the finished product is less than $150 are exempt).
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Staff estimates that the incremental burden associated with the
Regulations' invoice disclosure requirement, beyond the time that would
be devoted to preparing invoices in its absence, is approximately 30
seconds per invoice.\3\ The invoice disclosure requirement applies to
fur garments, which are generally sold individually, and fur pelts,
which are generally sold in groups of at least 50, on average. Assuming
invoices are prepared for sales of 3,000,000 garments and 160,000
groups (an estimated 8 million pelts / 50) each of imported and
domestic pelts, the invoice disclosure requirement entails an estimated
total burden of 26,333 hours.
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\3\ The invoice disclosure burden for PRA purposes excludes the
time that respondents would spend for invoicing, apart from the Fur
Act Regulations, in the ordinary course of business. See 5 CFR
1320.3(b)(2).3
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Staff estimates that the Regulations' advertising disclosure
requirements impose an average burden of one hour per year for each of
the approximately 1,300 domestic fur retailers, or a total of 1,300
hours.
Thus, staff estimates the total disclosure burden to be
approximately 113,633 hours (86,000 hours for labeling + 26,333 hours
for invoices + 1,300 hours for advertising).
Estimated annual cost burden: $2,153,000, rounded to the nearest
thousand (solely relating to labor costs).

[[Page 75463]]

Staff believes that there are no current start-up costs or other
capital costs associated with the Regulations. Because the labeling of
fur products has been an integral part of the manufacturing process for
decades, manufacturers have in place the capital equipment necessary to
comply with the Regulations' labeling requirements. Industry sources
indicate that much of the information required by the Fur Act and its
implementing Regulations would be included on the product label even
absent the regulations. Similarly, invoicing, recordkeeping, and
advertising disclosures are tasks performed in the ordinary course of
business so that covered firms would incur no additional capital or
other non-labor costs as a result of the Act or the Regulations.

2. Regulations Under the Wool Products Labeling Act, 15 U.S.C. 68 et
seq. (``Wool Act''), 16 CFR Part 300 (OMB Control Number: 3084-0100)

The Wool Act prohibits the misbranding of wool products. The Wool
Act Regulations, 16 CFR 300, establish disclosure requirements that
assist consumers in making informed purchasing decisions and
recordkeeping requirements that assist the Commission in enforcing the
Regulations.
Estimated annual hours burden: 407,000 hours, rounded to the
nearest thousand (80,000 recordkeeping hours + 326,667 disclosure
hours).
Recordkeeping: Staff estimates that approximately 4,000 wool firms
are subject to the Regulations' recordkeeping requirements. Based on an
average annual burden of 20 hours per firm, the total recordkeeping
burden is 80,000 hours.
Disclosure: Approximately 8,000 wool firms, producing or importing
about 500,000,000 wool products annually, are subject to the
Regulations' disclosure requirements. Staff estimates the burden of
determining label content to be 15 hours per year per respondent, or a
total of 120,000 hours, and the burden of drafting and ordering labels
to be 5 hours per respondent per year, or a total of 40,000 hours.
Staff believes that the process of attaching labels is now fully
automated and integrated into other production steps for about 40
percent of all affected products. For the remaining 300,000,000 items
(60 percent of 500,000,000), the process is semi-automated and requires
an average of approximately two seconds per item, for a total of
166,667 hours per year. Thus, the total estimated annual burden for all
respondents is 326,667 hours. Staff believes that any additional burden
associated with advertising disclosure requirements would be minimal
(less than 10,000 hours) and can be subsumed within the burden
estimates set forth above.
Estimated annual cost burden: $4,460,000, rounded to the nearest
thousand (solely relating to labor costs).

----------------------------------------------------------------------------------------------------------------
Task Hourly rate Burden hours Labor cost
----------------------------------------------------------------------------------------------------------------
Determine label content......................................... $20.00 120,000 $2,400,000
Draft and order labels.......................................... 13.00 40,000 520,000
Attach labels................................................... \5\ 3.00 166,667 500,001
Recordkeeping................................................... 13.00 80,000 1,040,000
-----------------
Total....................................................... .............. .............. 4,460,001
----------------------------------------------------------------------------------------------------------------
\5\ For products that are imported, this work generally is done in the country where they are manufactured.
According to information compiled by an industry trade association using data from the International Trade
Commission, the U.S. Customs Service, and the U.S. Census Bureau, approximately 90% of apparel and other
textile products used in the United States is imported. With the remaining 10% attributable to U.S. production
at an approximate domestic hourly wage of $8.50 to attach labels, staff has calculated a weighted average
hourly wage of $3 per hour attributable to U.S. and foreign labor combined. The estimated percentage of
imports supplied by particular countries is based on trade data for 2001 compiled by the Office of Textiles
and Apparel, International Trade Administration, U.S. Department of Commerce. Wages in major textile exporting
countries, factored into the above hourly wage estimate, were based on data published in February 2000 by the
U.S. Department of Labor, Bureau of International Labor Affairs (See ``Wages, Benefits, Poverty Line, and
Meeting Workers'' Needs in the Apparel and Footwear Industries of Selected Countries,'' Table I-2:
``Prevailing or Average Wages in the Manufacturing Sector and in the Footwear and Apparel Industries in
Selected Countries, Latest Available Year'').

Staff believes that there are no current start-up costs or other
capital costs associated with the Regulations. Because the labeling of
wool products has been an integral part of the manufacturing process
for decades, manufacturers have in place the capital equipment
necessary to comply with the Regulations. Based on knowledge of the
industry, staff believes that much of the information required by the
Wool Act and its implementing regulations would be included on the
product label even absent their requirements. Similarly, recordkeeping
and advertising disclosures are tasks performed in the ordinary course
of business so that covered firms would incur no additional capital or
other non-labor costs as a result of the Regulations.

3. Regulations Under the Textile Fiber Products Identification Act, 15
U.S.C. 70 et seq. (``Textile Act''), 16 CFR Part 303 (OMB Control
Number: 3084-0101)

The Textile Act prohibits the misbranding and false advertising of
textile fiber products. The Textile Act Regulations, 16 CFR 303,
establish disclosure requirements that assist consumers in making
informed purchasing decisions, and recordkeeping requirements that
assist the Commission in enforcing the Regulations. The Regulations
also contain a petition procedure for requesting the establishment of
generic names for textile fibers.5
Estimated annual hours burden: approximately 8,011,000 hours,
rounded to the nearest thousand (600,000 recordkeeping hours +
7,411,111 disclosure hours).
Recordkeeping: Staff estimates that approximately 24,000 textile
firms are subject to the Textile Regulations' recordkeeping
requirements. Based on an average burden of 25 hours per firm, the
total recordkeeping burden is 600,000 hours.
Disclosure: Approximately 32,000 textile firms, producing or
importing about 19.9 billion textile fiber products annually, are
subject to the Regulations' disclosure requirements.\6\ Staff

[[Page 75464]]

estimates the burden of determining label content to be 20 hours per
year per respondent, or a total of 640,000 hours and the burden of
drafting and ordering labels to be 5 hours per respondent per year, or
a total of 160,000 hours. Staff believes that the process of attaching
labels is now fully automated and integrated into other production
steps for about 40 percent of all affected products. For the remaining
11.9 billion items (60 percent of 19.9 billion), the process is semi-
automated and requires an average of approximately two seconds per
item, for a total of 6,611,111 hours per year. Thus, the total
estimated annual burden for all respondents is 7,411,111 hours. Staff
believes that any additional burden associated with advertising
disclosure requirements or the filing of generic fiber name petitions
would be minimal (less than 10,000 hours) and can be subsumed within
the burden estimates set forth above.
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\6\ The apparent consumption of garments in the U.S. in 2004 was
18.4 billion. Staff estimates that 1 billion garments are exempt
from the Textile Act (i.e., any kind of headwear and garments made
from something other than a textile fiber product, such as leather)
or are subject to a special exemption for hosiery products sold in
packages where the label information is contained on the package.
Based on available data, staff estimates that an additional 3
billion household textile products (non-garments, such as sheets,
towels, blankets) were consumed. However, approximately .5 billion
of all of these combined products (garments and non-garments) are
subject to the Wool Products Labeling Act, not the Textile Fiber
Products Identification Act, because they contain some amount of
wool. Thus, the estimated net total products subject to the Textile
Fiber Products Identification Act is 19.9 billion.
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Estimated annual cost burden: $42,513,000, rounded to the nearest
thousand (solely relating to labor costs).

Staff believes that there are no current start-up costs or other
capital costs associated with the Regulations. Because the labeling of
textile products has been an integral part of the manufacturing process
for decades, manufacturers have in place the capital equipment
necessary to comply with the Regulations' labeling requirements.
Industry sources indicate that much of the information required by the
Textile Act and its implementing rules would be included on the product
label even absent their requirements. Similarly, recordkeeping,
invoicing, and advertising disclosures are tasks performed in the
ordinary course of business so that covered firms would incur no
additional capital or other non-labor costs as a result of the
Regulations.

4. The Care Labeling Rule, 16 CFR Part 423 (OMB Control Number: 3084-
0103)

The Care Labeling Rule, 16 CFR Part 423, requires manufacturers and
importers to attach a permanent care label to all covered textile
clothing in order to assist consumers in making purchase decisions and
in determining what method to use to clean their apparel. Also,
manufacturers and importers of piece goods used to make textile
clothing must provide the same care information on the end of each bolt
or roll of fabric.
Estimated annual hours burden: 6,889,000 hours, rounded to the
nearest thousand (solely relating to disclosure \8\).
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\8\ The Care Labeling Rule imposes no specific recordkeeping
requirements. Although the Rule requires manufacturers and importers
to have reliable evidence to support the recommended care
instructions, companies may provide as support current technical
literature or rely on past experience.
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Staff estimates that approximately 24,700 manufacturers or
importers of textile apparel, producing about 17.4 billion textile
garments annually, are subject to the Rule's disclosure requirements.
The burden of developing proper care instructions may vary greatly
among firms, primarily based on the number of different lines of
textile garments introduced per year that require new or revised care
instructions. Staff estimates the burden of determining care
instructions to be 43 hours each year per respondent, for a cumulative
total of 1,062,100 hours. Staff further estimates that the burden of
drafting and ordering labels is 2 hours each year per respondent, for a
total of 49,400 hours. Staff believes that the process of attaching
labels is fully automated and integrated into other production steps
for about 40 percent of the approximately 17.4 billion garments that
are required to have care instructions on permanent labels.\9\ For the
remaining 10.4 billion items (60 percent of 17.4 billion), the process
is semi-automated and requires an average of approximately two seconds
per item, for a total of 5,777,778 hours per year. Thus, the total
estimated annual burden for all respondents is 6,889,278 hours.
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\9\ About 1 billion of the 18.4 billion garments produced
annually are either not covered by the Care Labeling Rule (gloves,
hats, caps, and leather, fur, plastic, or leather garments) or are
subject to an exemption that allows care instructions to appear on
packaging (hosiery).
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Estimated annual cost burden: $39,218,000, rounded to the nearest
thousand (solely relating to labor costs).

Staff believes that there are no current start-up costs or other
capital costs associated with the Rule. Because the labeling of textile
products has been an integral part of the manufacturing process for
decades, manufacturers have in place the capital equipment necessary to
comply with the Rule's labeling requirements. Based on knowledge of the
industry, staff believes that much of the information required by the
Rule would be included on the

[[Page 75465]]

product label even absent those requirements.

William Blumenthal,
General Counsel.
[FR Doc. E5-7531 Filed 12-19-05; 8:45 am]
BILLING CODE 6750-01-P

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