Notices. Notice

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BILLING CODE 6712-01-P FEDERAL TRADE COMMISSION Agency Information Collection Activities; Submission for OMB Review; Comment Request AGENCY: Federal Trade Commission. ACTION: Notice. 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”). The Federal Trade Commission (“FTC” or “Commission”) is seeking public comments on its proposal to extend through April 30, 2010 the current OMB clearance for information collection requirements contained in its Contact Lens Rule (“Rule”).

That clearance expires on April 30, 2007. DATES: Comments must be filed by February 16, 2007. ADDRESSES: Interested parties are invited to submit written comments. Comments should refer to “Contact Lens Rule: FTC File No. [R411002],” 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, Room H-135 (Annex J), 600 Pennsylvania Ave., 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, as prescribed below. 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 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). Comments filed in electronic form should be submitted by following the instructions on the web-based form at *https://secure.commentworks.com/ContactLensRule* . To ensure that the Commission considers an electronic comment, you must file it on the Web-based form at the *https://secure.commentworks.com/ContactLensRule* Weblink.

If this notice appears at *http://www.regulations.gov* , you may also file an electronic comment through that Web site. The Commission will consider all comments that regulations.gov forwards to it. 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 Web site, to the extent practicable, at *http://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 *http://www.ftc.gov/ftc/privacy.htm* . FOR FURTHER INFORMATION CONTACT: Requests for additional information should be addressed to Keith Fentonmiller, Attorney, Division of Advertising Practices, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue, NW., Washington, DC 20580,

(202)326-2775. SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act (“PRA”), 44 U.S.C. 3501-3520, Federal agencies must obtain approval from OMB for each collection of information they conduct or sponsor. “Collection of information” means agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. 44 U.S.C. 3502(3); 5 C.F.R. 1320.3(c). As required by section 3506(c)(2)(A) of the PRA, the FTC is providing this opportunity for public comment before requesting that OMB extend the existing paperwork clearance for the regulations noted herein. The FTC invites comments on:

(1)Whether the required collection of information is necessary for the proper performance of the functions of the agency, including whether the information has practical utility;

(2)the accuracy of the agency's estimate of the burden of the required 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 those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, *e.g.* , permitting electronic submission of responses. All comments should be filed as prescribed in the ADDRESSES section above, and must be received on or before February 16, 2007. The Contact Lens Rule (“Rule”), 16 CFR Part 315, was promulgated by the FTC pursuant to the Fairness to Contact Lens Consumers Act (“FCLCA”), Pub. L. No. 108-164 (December 6, 2003), which was enacted to enable consumers to purchase contact lenses from the seller of their choice. The Rule became effective on August 2, 2004. As mandated by the FCLCA, the Rule requires the release and verification of contact lens prescriptions and contains recordkeeping requirements applying to both prescribers and sellers of contact lenses. Specifically, the Rule requires that prescribers provide a copy of the prescription to the consumer upon the completion of a contact lens fitting and verify or provide prescriptions to authorized third parties. The Rule also mandates that a contact lens seller may sell contact lenses only in accordance with a prescription that the seller either:

(a)Has received from the patient or prescriber; or

(b)has verified through direct communication with the prescriber. In addition, the Rule imposes recordkeeping requirements on contact lens prescribers and sellers. For example, the Rule requires prescribers to document in their patients' records the medical reasons for setting a contact lens prescription expiration date of less than one year. The Rule requires contact lens sellers to maintain records for three years of all direct communications involved in obtaining verification of a contact lens prescription, as well as prescriptions, or copies thereof, which they receive directly from customers or prescribers. The information retained under the Rule's recordkeeping requirements is used by the Commission to substantiate compliance with the Rule and may also provide a basis for the Commission to bring an enforcement action. Without the required records, it would be difficult either to ensure that entities are complying with the Rule's requirements or to bring enforcement actions based on violations of the Rule. Commission staff estimates the paperwork burden of the FCLCA and Rule based on its knowledge of the eye care industry. Staff believes there will be some burden on individual prescribers to provide contact lens prescriptions, although it involves merely writing a few items of information onto a slip of paper and handing it to the patient, or perhaps mailing or faxing it to a third party. In addition, there will be some recordkeeping burden on contact lens sellers—including retaining prescriptions or records of “direct communications”—pertaining to each sale of contact lenses to consumers who received their original prescription from a third party prescriber. *Burden statement:* *Estimated total annual hours burden:* 950,000 hours (rounded to the nearest thousand). In its 2003 PRA-related **Federal Register** Notice and corresponding submission to OMB, FTC staff estimated that the annual paperwork burden for the various disclosure and recordkeeping requirements under the FCLCA and then-proposed Rule would be approximately 600,000 disclosure hours for contact lens prescribers and approximately 300,000 recordkeeping hours for contact lens sellers, a combined industry total of 900,000 hours. No provisions in the Rule have been amended since staff's prior submission to OMB. Thus, the Rule's disclosure and recordkeeping requirements remain the same. However, the number of contact lens wearers in the United States has increased to approximately 38 million. 2 Thus, assuming an annual contact lens exam for each contact lens wearer, 38 million people would receive a copy of their prescription each year under the Rule. At an estimated one minute per prescription, the annual time spent by prescribers complying with the disclosure requirement would be a maximum of 633,333 hours. [(38 million × 1 minute)/60 minutes = 633,333 hours] 2 *See* Statistics on Eyeglasses and Contact Lenses,” All About Vision, August, 2006, available at *http://www.allaboutvision.com/resources/statistics-eyewear.htm* . *See also* Barr, J. “2004 Annual Report,” Contact Lens Spectrum, Jan. 2005, available at *http://www.clspectrum.com/article.aspx?article=12733* . As required by the FCLCA, the Rule also imposes two recordkeeping requirements. First, prescribers must document the specific medical reasons for setting a contact lens prescription expiration date shorter than the one year minimum established by the FCLCA. This burden is likely to be nil because the requirement applies only in cases when the prescriber invokes the medical judgment exception, which is expected to occur infrequently, and prescribers are likely to record this information in the ordinary course of business as part of their patients' medical records. The OMB regulation that implements the PRA defines “burden” to exclude any effort that would be expended regardless of a regulatory requirement. 5 CFR 1320.3(B)(3)(2). Second, the Rule requires contact lens sellers to maintain certain documents relating to contact lens sales. As noted above, a seller may sell contact lenses only in accordance with a prescription that the seller either

(a)Has received from the patient or prescriber, or

(b)has verified through direct communication with the prescriber. The FCLCA requires sellers to retain prescriptions and records of communications with prescribers relating to prescription verification for three years. Staff believes that the burden of complying with this requirement is low. Essentially, sellers who seek verification of contact lens prescriptions must retain one or two records for each contact lens sale: Either the relevant prescription itself, or the verification request and any response from the prescriber. Staff estimates that such recordkeeping will entail a maximum of five minutes per sale, including time spent preparing a file and actually filing the record(s). Staff also believes that, based on its knowledge of the industry, this burden will fall primarily on mail order and Internet-based sellers of contact lenses, as they are the entities in the industry most reliant on obtaining or verifying contact lens prescriptions. Based on conversations with the industry, staff estimates that these entities currently account for approximately 10% of sales in the contact lens market 3 and, by extension, that approximately 3.8 million consumers—10% of the 38 million contact lens wearers in the United States—purchase their lenses from them. 3 The FTC's February 2005 study, “The Strength of Competition in the Rx Sale of Contact Lenses: An FTC Study,” cites various data that, averaged together, suggests that approximately 10% of contact lens sales are by online and mail-order sellers. The report is available online at *http://www.ftc.gov/reports/contactlens/050214contactlensrpt.pdf* . At an estimated five minutes per sale to each of 3.8 million consumers, contact lens sellers will spend a total of 316,667 burden hours complying with the recordkeeping requirement. [(3.8 million × 5 minutes)/60 minutes = 316,667 hours] This estimate likely overstates the actual burden, however, because it includes the time spent by sellers who already keep records pertaining to contact lens sales in the ordinary course of business. In addition, the estimate may overstate the time spent by sellers to the extent that records ( *e.g.* , verification requests) are generated and stored automatically and electronically, which staff understands is the case for some larger online sellers. *Estimated labor costs:* $32,819,000 (rounded to the nearest thousand). Commission staff derived labor costs by applying appropriate hourly cost figures to the burden hours described above. Staff estimates, based on its knowledge of the industry, that optometrists account for approximately 75% of prescribers. Thus, for simplicity, staff will focus on their average hourly wage in estimating prescribers' labor cost burden. According to Bureau of Labor Statistics from May 2005, salaried optometrists earn an average wage of $45.91 per hour and clerical personnel earn an average of $11.82 per hour. 4 With these categories of personnel, respectively, likely to perform the brunt of the disclosure and recordkeeping aspects of the Rule, estimated total labor cost attributable to the Rule would be approximately $32.8 million. [($45.91 × 633,333 hours) + ($11.82 × 316,667 hours) = $32,819,322] . 4 The Bureau of Labor Statistics are available online at: *http://www.bls.gov/oes/current/oes_nat.htm#b43-0000* . The contact lens market is a multi-billion dollar market; one recent survey estimates that contact lens sales totaled $2.35 billion from June 2005 to June 2006. 5 Thus, the total labor cost burden estimate of $32.8 million represents approximately 1% of the overall market. 5 The Vision Council of America and Jobson Optical Research have conducted large scale continuous consumer research under the name VisionWatch, which reports on vision care industry and is available at *http://visionsite.org/s_vision/doc.asp?CID=791&DID=2524* . *Estimated annual non-labor cost burden:* $0 or minimal. Staff believes that the Rule's disclosure and recordkeeping requirements impose negligible capital or other non-labor costs, as the affected entities are likely to have the necessary supplies and/or equipment already ( *e.g.* , prescription pads, patients' medical charts, facsimile machines and paper, telephones, and recordkeeping facilities such as filing cabinets or other storage). William Blumenthal, General Counsel. [FR Doc. E6-21514 Filed 12-15-06; 8:45 am] BILLING CODE 6750-01-P FEDERAL TRADE COMMISSION [File No. 061 0220, Docket No. C-4180] Johnson & Johnson and Pfizer Inc.; Analysis of Agreement Containing Consent Orders To Aid Public Comment AGENCY: Federal Trade Commission. ACTION: Proposed Consent Agreement. SUMMARY: The consent agreement in this matter settles alleged violations of Federal law prohibiting unfair or deceptive acts or practices or unfair methods of competition. The attached Analysis to Aid Public Comment describes both the allegations in the draft complaint and the terms of the consent order—embodied in the consent agreement—that would settle these allegations. DATES: Comments must be received on or before January 11, 2007. ADDRESSES: Interested parties are invited to submit written comments. Comments should refer to “Johnson & Johnson and Pfizer, File No. 061 0220,” 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 to the following address: Federal Trade Commission/Office of the Secretary, Room 135-H, 600 Pennsylvania Avenue, NW., Washington, DC 20580. Comments containing confidential material must be filed in paper form, must be clearly labeled “Confidential,” and must comply with Commission Rule 4.9(c). 16 CFR 4.9(c) (2005). 1 The FTC is requesting that any comment filed in paper form be sent by courier or overnight service, if possible, because U.S. postal mail in the Washington area and at the Commission is subject to delay due to heightened security precautions. Comments that do not contain any nonpublic information may instead be filed in electronic form as part of or as an attachment to e-mail messages directed to the following e-mail box: *consentagreement@ftc.gov* . 1 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). 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, whether filed in paper or electronic form, will be considered by the Commission, and will be available to the public on the FTC Web site, to the extent practicable, at *http://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 *http://www.ftc.gov/ftc/privacy.htm* . FOR FURTHER INFORMATION CONTACT: Michael R. Moiseyev, Bureau of Competition, 600 Pennsylvania Avenue, NW., Washington, DC 20580,

(202)326-3106. SUPPLEMENTARY INFORMATION: Pursuant to section 6(f) of the Federal Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46(f), and § 2.34 of the Commission Rules of Practice, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing a consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty

(30)days. The following Analysis to Aid Public Comment describes the terms of the consent agreement, and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC Home Page (for December 12, 2006), on the World Wide Web, at *http://www.ftc.gov/os/2006/12/index.htm* . A paper copy can be obtained from the FTC Public Reference Room, Room 130-H, 600 Pennsylvania Avenue, NW., Washington, DC 20580, either in person or by calling

(202)326-2222. Public comments are invited, and may be filed with the Commission in either paper or electronic form. All comments should be filed as prescribed in the ADDRESSES section above, and must be received on or before the date specified in the DATES section. I. Analysis of Agreement Containing Consent Order To Aid Public Comment The Federal Trade Commission (“Commission”) has accepted, subject to final approval, an Agreement Containing Consent Orders (“Consent Agreement”) from Johnson & Johnson (“J&J”) and Pfizer Inc. (“Pfizer”), which is designed to remedy the anticompetitive effects that would otherwise result from J&J's proposed acquisition of Pfizer Consumer Healthcare. Under the terms of the proposed Consent Agreement, the parties will be required to divest:

(1)Pfizer's Zantac® H-2 blocker business;

(2)Pfizer's Cortizone® hydrocortisone anti-itch business;

(3)Pfizer's Unisom® nighttime sleep-aid business; and

(4)J&J's Balmex® diaper rash treatment business. The proposed Consent Agreement has been placed on the public record for thirty

(30)days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After thirty

(30)days, the Commission will again review the proposed Consent Agreement and will decide whether it should withdraw from the proposed Consent Agreement, modify it, or make final the Decision and Order (“Order”). Pursuant to a Stock and Asset Purchase Agreement dated June 25, 2006, J&J proposes to acquire certain voting securities and assets comprising Pfizer's Consumer Healthcare business in a transaction valued at approximately $16.6 billion (“Proposed Acquisition”). The Commission's complaint alleges that the Proposed Acquisition, if consummated, would violate section 7 of the Clayton Act, as amended, 15 U.S.C. 18, and section 5 of the Federal Trade Commission Act, as amended, 15 U.S.C. 45, by lessening competition in the United States markets for the research, development, manufacture, distribution, and sale of the following over-the-counter (“OTC”) medications:

(1)H-2 blockers,

(2)hydrocortisone anti-itch products,

(3)nighttime sleep-aids, and

(4)diaper rash treatments (the “Products”). II. The Parties J&J is one of the largest and most diversified suppliers of branded consumer health care products in the world, as well as a manufacturer and supplier of pharmaceuticals, medical devices, and diagnostic products. In 2005, J&J had worldwide net sales of $50.5 billion. The more than 230 J&J operating companies employ approximately 116,000 individuals in 57 countries and sell products throughout the world. In the consumer products segment, J&J manufactures and markets a broad range of OTC medications, women's health products, nutritional products, oral care products, and products used for baby and skin care. With its Pepcid® line of products, J&J is the leading supplier of OTC H-2 blocker acid relief products in the United States. J&J is also a leading supplier of OTC hydrocortisone-based anti-itch medications under its Cortaid® and Aveeno® brands and of OTC nighttime sleep-aids under its Simply Sleep® brand. J&J is also a leading supplier of products for treating diaper rash under its Balmex®, Aveeno®, and Johnson's® No More Rash® brands. Pfizer is one of the largest pharmaceutical companies in the world. Pfizer researches, develops, manufactures, and markets leading prescription medicines for humans and animals, as well as consumer healthcare products. In 2005, Pfizer had worldwide net sales of $51.3 billion. Pfizer Consumer Healthcare, which J&J proposes to acquire, is a global business that researches, develops, manufactures, and markets many well-known brands of OTC medications and oral care products to consumers throughout the world. In 2005, Pfizer Consumer Healthcare generated net sales of $3.9 billion. Like J&J, Pfizer is one of the leading suppliers of OTC H-2 blocker acid relief products in the United States with its Zantac® product line. Pfizer is also the leading supplier in the United States of OTC hydrocortisone anti-itch medications under its Cortizone® brand, OTC nighttime sleep-aids under its Unisom® brand, and diaper rash products under its Desitin® brand. III. OTC H-2 Blockers One of the relevant markets in which to assess the competitive effects of the Proposed Acquisition is the United States market for OTC H-2 blockers. H <sup>2</sup> -receptor antagonists, more commonly known as “H-2 blockers,” are a class of drugs for the prevention and relief of heartburn associated with acid indigestion. Originally a prescription medicine, H-2 blocker products were later approved by the FDA for sale without a prescription. H-2 blockers work by blocking histamine from stimulating the gastric parietal cells, thereby suppressing secretion of stomach acid. Although there are other OTC acid relief medications, including antacids and proton pump inhibitors (“PPIs”), H-2 blockers are sufficiently different from these other products that they are not close economic substitutes. Currently, Prilosec OTC® is the only PPI available without a prescription. OTC PPIs are not a close substitute for OTC H-2 blockers because they are indicated for the relief of chronic heartburn and not for immediate relief of occasional heartburn or indigestion. Antacid tablets and liquids are not a close substitute for OTC H-2 blockers because they are less efficacious and do not provide as long relief as H-2 blockers. The United States market for OTC H-2 blockers is highly concentrated. Today, this approximately $360 million market comprises four branded products—J&J's Pepcid®, Pfizer's Zantac®, GlaxoSmithKline's Tagamet®, and Reliant Pharmaceutical's Axid AR®—and private label versions of some Pepcid®, Zantac®, and Tagamet® products. J&J and Pfizer are the two largest suppliers in this market. The Proposed Acquisition would significantly increase market concentration and eliminate substantial competition between the two leading suppliers of OTC H-2 blockers in the United States. Branded manufacturers of these products spend significant sums of money annually to create and maintain distinct brand equities. As a result of the acquisition, J&J would account for over 70% of the sales of OTC H-2 blocker in the United States. Here the evidence confirmed that Pepcid® and Zantac® are close substitutes. Consumers have benefitted from the competition between Pfizer and J&J on pricing, discounts, promotional trade spending, and product innovation. Thus, unremedied, the Proposed Acquisition likely would cause significant anticompetitive harm by enabling J&J to profit by unilaterally raising the prices of one or both products above pre-merger levels, as well as reducing its incentives to innovate and develop new products. IV. OTC Hydrocortisone Anti-Itch Products A second relevant product market in which to assess the competitive effects of the Proposed Acquisition is the United States market for OTC hydrocortisone anti-itch products. Hydrocortisone is a corticosteroid that reduces or inhibits the actions of chemicals in the body that cause inflammation, redness and swelling. OTC products containing up to 1.0 percent hydrocortisone are approved by the FDA for topical application to treat minor skin irritations, itching, and rashes due to various conditions, including dermatitis, eczema, and psoriasis. Although OTC topical anesthetic and antihistamine products are available to treat minor skin irritations, itching and rashes, these products are not close economic substitutes for hydrocortisone anti-itch products because they work differently than hydrocortisone products. While these products may relieve symptoms of pain or itching, unlike hydrocortisone, they do nothing to cure or prevent the actual underlying skin conditions such as eczema or psoriasis. The United States market for OTC hydrocortisone anti-itch products is highly concentrated. There are only two significant branded competitors in this market:

(1)Pfizer, with its Cortizone® products and

(2)J&J, with its Cortaid® products. In addition, private label hydrocortisone anti-itch products account for a significant share of the market. Pfizer's Cortizone® is the market leader among branded products, while J&J's Cortaid® is the second leading branded product line. In 2005, sales of OTC hydrocortisone anti-itch products in the United States totaled approximately $120 million. The Proposed Acquisition would significantly increase market concentration and eliminate substantial competition between the two leading suppliers of OTC hydrocortisone anti-itch products in the United States. As a result of the acquisition, J&J would account for over 55% of the sales of OTC hydrocortisone anti-itch products in the United States. Evidence indicates that the parties' products compete on many levels, including pricing, shelf-space, and advertising. By eliminating competition between the two leading branded suppliers, the Proposed Acquisition would likely result in higher prices, less promotional spending, and reduced product innovation. Although private label OTC hydrocortisone anti-itch products account for a significant share of the market, private label products are less close substitutes for a significant share of customers, and it is unlikely that private label products would be able to reposition themselves to replace the competition between J&J and Pfizer, the two largest branded competitors in this market, that would be lost through the Proposed Acquisition. Thus, unremedied, the Proposed Acquisition likely would cause significant anticompetitive harm by enabling J&J to profit by unilaterally raising the prices of one or both products above pre-merger levels, as well as reducing its incentives to innovate and develop new products. V. OTC Nighttime Sleep-Aids A third relevant product market in which to assess the competitive effects of the Proposed Acquisition is the United States market for OTC nighttime sleep-aids. OTC nighttime sleep-aids are non-prescription drugs that are indicated solely for the relief of occasional sleeplessness by individuals who have difficulty falling asleep. The active ingredient in the best-selling sleep-aids is a sedating antihistamine, such as diphenhydramine hydrochloride or doxylamine succinate. Prescription sleep-aids, such as zolpidem (Ambien®), zaleplon (Sonata®) or eszopiclone (Lunesta®), are not close economic substitutes for OTC nighttime sleep-aids. Consumers of OTC nighttime sleep-aids likely would not switch to prescription sleep-aids in response to a 5 to 10 percent increase in the price of OTC nighttime sleep-aids because of the higher prices of prescription sleep-aids (particularly for those without insurance coverage) and the inconvenience and cost of a doctor's visit (including delays for consumers who have exhausted their prescriptions). The United States market for OTC nighttime sleep-aids is highly concentrated. J&J and Pfizer are the two largest suppliers of branded OTC nighttime sleep-aids in the United States. Pfizer is the market leader with its Unisom® products, while J&J is the second leading supplier with its Simply Sleep® products. In 2005, sales of OTC nighttime sleep-aids in the United States totaled approximately $100 million. The Proposed Acquisition would significantly increase market concentration and eliminate substantial competition between the two leading suppliers of OTC nighttime sleep-aids in the United States. As a result of the acquisition, J&J would account for over 45% of the sales of OTC nighttime sleep-aids in the United States. In addition, the evidence confirmed that Unisom® and Simply Sleep® are close substitutes and have similar efficacy, brand equity, and brand positioning. Consumers have benefitted from the competition between Pfizer and J&J on pricing, discounts, promotional trade spending, and product innovation. Although private label OTC nighttime sleep-aids account for a significant share of the market, private label products are less close substitutes for a significant share of customers, and it is unlikely that private label products would reposition themselves to replace the competition between J&J and Pfizer, the two largest branded competitors in this market, that would be lost through the Proposed Acquisition. Thus, unremedied, the Proposed Acquisition likely would cause significant anticompetitive harm by enabling J&J to profit by unilaterally raising the prices of one or both products above pre-merger levels, as well as reducing its incentives to innovate and develop new products. VI. OTC Diaper Rash Treatments A fourth relevant product market in which to assess the competitive effects of the Proposed Acquisition is the United States market for OTC diaper rash treatment products. Consumers use diaper rash creams or ointments to treat and prevent diaper rash and to protect sore or chafed skin from moisture or irritation. Most diaper rash products fall into one of two categories:

(1)Creams or pastes containing the active ingredient zinc oxide and

(2)ointments containing the active ingredient petrolatum. There are no close substitutes for OTC diaper rash creams or ointments. The United States market for OTC diaper rash treatments is highly concentrated. Today, three large, established brands—Pfizer's Desitin®, Schering-Plough's A&D®, and J&J's Balmex®—account for over 70% of sales in this approximately $84 million market. The rest of the market is composed of several small, niche brands. Private label products account for a negligible share of the market. Pfizer is the largest supplier of OTC diaper rash treatment products with its Desitin® line of products, while J&J is the third largest supplier with its Balmex®, Aveeno®, and Johnson's® No More Rash® brands. Neither the Aveeno® nor the Johnson's® No More Rash® brands, however, account for a significant share of sales in this market. The Proposed Acquisition would significantly increase market concentration and eliminate substantial competition between the two leading suppliers of OTC diaper rash treatment products in the United States. As a result of the acquisition, J&J would account for nearly 50% of the sales of OTC diaper rash treatment products in the United States. Although there are additional suppliers of branded OTC diaper rash treatment products in this market, the evidence confirmed that Desitin® and Balmex® are perceived to be close substitutes by consumers, and evidence suggests that they are similar in formulation, texture, and appearance. Consumers have benefitted from the competition between Pfizer and J&J on pricing, discounts, promotional trade spending, and product innovation. Thus, unremedied, the Proposed Acquisition likely would cause significant anticompetitive harm by enabling J&J to profit by unilaterally raising the prices of one or both products above pre-merger levels, as well as reducing its incentives to innovate and develop new products. VII. Entry Entry into the markets for the research, development, manufacture, and sale of the Products is unlikely to deter or counteract the anticompetitive effects of the Proposed Acquisition. Each of the relevant markets is relatively mature and dominated by a few well-established brand names. In such a market environment, a new entrant faces a difficult task of convincing retailers to carry its product, especially if the new product does not have a competitive advantage based on differentiated claims or efficacy. Developing and obtaining Food and Drug Administration approval for the manufacture and sale of a novel, differentiated medication takes at least two

(2)years. Once product development is complete, a new entrant must invest extremely high sunk costs on marketing, advertising, and promotional allowances to create and maintain consumer awareness and acceptance of the new product. Given the sales opportunities available in the markets for the Products, coupled with the significant investment necessary to market and sell the Products, it is unlikely that a new competitor will enter any of the markets for the Products. VIII. The Consent Agreement The Consent Agreement effectively remedies the Proposed Acquisition's anticompetitive effects in the relevant markets discussed above. The Consent Agreement preserves competition in these markets by requiring the divestiture of:

(1)All assets related to the Zantac® H-2 blockers to Boehringer Ingelheim Pharmaceuticals, Inc. (“Boehringer Ingelheim Pharmaceuticals”); and

(2)all assets relating to Cortizone® hydrocortisone anti-itch products, all assets relating to Unisom® sleep-aids, and all assets relating to Balmex® diaper rash treatment products to Chattem, Inc. (“Chattem”) (the “Divested Assets”). These divestitures must take place within fifteen days after the closing of the Proposed Acquisition or January 2, 2007, whichever is later. The Commission is satisfied that Boehringer Ingelheim Pharmaceuticals is a well-qualified acquirer of the Zantac business. Boehringer Ingelheim Pharmaceuticals engages in the research, development, sale and marketing of branded pharmaceuticals and OTC drugs, including well known brands such as Dulcolax®, Spiriva®, Atrovent®, Combivent®, Flomax® and Mirapex®. Boehringer Ingelheim Pharmaceuticals is part of the Boehringer Ingelheim Group, which is a leading worldwide manufacturer of pharmaceuticals for humans and animals and the eighth largest manufacturer and marketer of OTC health care products worldwide. Boehringer Ingelheim Pharmaceutical's Consumer Health Care business has an existing sales and distribution network that sells products through the same channels as Zantac® is currently sold, and has a strong record of integrating product acquisitions successfully. The proposed Consent Agreement contains several provisions designed to ensure the successful divestiture of the Zantac® business to Boehringer Ingelheim Pharmaceuticals by requiring that:

(1)J&J divest to Boehringer Ingelheim Pharmaceuticals all assets relating to Pfizer's Zantac® line of products, including all research and development, intellectual property, and customer and supply contracts;

(2)J&J and Pfizer take steps to ensure that confidential business information relating to Zantac® will not be obtained or used by J&J;

(3)Boehringer Ingelheim Pharmaceuticals have the opportunity to enter into employment contracts with certain key individuals who have experience relating to Zantac®; and

(4)certain management employees of Pfizer who were substantially involved in the research, development or marketing of Zantac® be precluded from working on competitive H-2 blocker products at J&J for a period of two years. 2 2 This firewall will prevent J&J from taking competitive advantage of know-how, product development, marketing, and sales plans relating to Zantac®. The Commission is also satisfied that Chattem is a well-qualified acquirer of the Cortisone®, Unisom®, and Balmex® businesses. Chattem is a leading manufacturer and marketer of a broad portfolio of branded OTC healthcare products, toiletries, and dietary supplements, including brands such as Icy Hot®, Gold Bond®, Selsun blue®, Garlique®, Pamprin®, and BullFrog®. Chattem's products are among the market leaders in their respective categories across food, drug and mass merchandisers. Chattem has an experienced sales force with existing relationships with major retailers and has a strong record of integrating prior product acquisitions successfully. The proposed Consent Agreement contains several provisions designed to ensure the successful divestiture of the Cortisone®, Unisom®, and Balmex® businesses to Chattem by requiring that:

(1)J&J divest to Chattem all assets relating to the Cortisone®, Unisom®, and Balmex® line of products, including all research and development, intellectual property, and customer and supply contracts;

(2)J&J and Pfizer take steps to ensure that confidential business information relating to Cortisone®, Unisom®, and Balmex® will not be obtained or used by J&J; and

(3)Chattem have the opportunity to enter into employment contracts with certain key individuals who have experience relating to Cortisone®, Unisom®, and Balmex®. The Order to Maintain Assets that is included in the proposed Consent Agreement requires that J&J and Pfizer maintain the viability of the Divested Assets for the brief transition period between the time the Commission approves the proposed Order and when the divestitures take place, which will not be later than January 2, 2007. Even though such a period is relatively short, maintenance of current supply, advertising and promotional levels and activities at all times prior to divestiture is of paramount importance. The proposed Consent Agreement incorporates this plan in the Order to Maintain Assets, detailing requirements for the assets that must be held separate, services that may be shared with the ongoing business, and the employee positions that are necessary for the held separate business. The Commission has appointed David Painter of LECG as Interim Monitor to oversee the transfer of assets, the establishment of appropriate firewalls to prevent the transfer or use of confidential business information and to ensure that J&J and Pfizer comply with all other provisions of the Order. To ensure that the Commission remains informed about the status of the Divested Assets and their transfer, the proposed Consent Agreement requires J&J and Pfizer to file reports with the Commission periodically until the divestitures are accomplished. The purpose of this analysis is to facilitate public comment on the proposed Consent Agreement, and it is not intended to constitute an official interpretation of the proposed Decision and Order or the Order to Maintain Assets, or to modify their terms in any way. By direction of the Commission with Commissioners Harbour, Kovacic and Rosch recused. Donald S. Clark, Secretary. [FR Doc. E6-21519 Filed 12-15-06; 8:45 am] BILLING CODE 6750-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-07-07AA] Proposed Data Collections Submitted for Public Comment and Recommendations In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention

(CDC)will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404-639-5960 and send comments to Seleda Perryman, CDC Assistant Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to *omb@cdc.gov* . Comments are invited on:

(a)Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;

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

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

(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice. Proposed Project Pilot Project for a National Monitoring System for Major Adverse Effects of Medication Use During Pregnancy and Lactation—New—National Center on Birth Defects and Developmental Disabilities (NCBDDD), Centers for Disease Control and Prevention (CDC). Background and Brief Description This data collection is based on the following components of the Public Health Service Act:

(1)Act 42 U.S.C. 241, Section 301, which authorizes “research, investigations, experiments, demonstrations, and studies relating to the causes, diagnosis, treatment, control, and prevention of physical and mental diseases and impairments of man.”

(2)42 U.S.C. 247b-4, Section 317 C, which authorizes the activities of the National Center on Birth Defects and Developmental Disabilities. This section was created by Public Law 106-310, also known as “the Children's Health Act of 2000.” This portion of the code has also been amended by Public Law 108-154, which is also known as the “Birth Defects and Developmental Disabilities Prevention Act of 2003”. The use of a number of medications during pregnancy is known to be associated with serious adverse effects in children. However, because pregnant and lactating women are traditionally excluded from clinical trials, and because premarketing animal studies do not necessarily predict the experience of humans, little information is available about the safety of most prescription medications during pregnancy and lactation at the time they are marketed. Nevertheless, many women inadvertently use medications early in gestation before realizing they are pregnant, and many maternal conditions require treatment during pregnancy and breastfeeding to safeguard the health of both mother and infant. Currently, the United States does not have a comprehensive early warning system for major adverse pregnancy or infant outcomes related to medication exposures. Teratology Information Services

(TIS)utilize trained specialists to provide free phone consultation, risk assessment, and counseling about exposures during pregnancy and breastfeeding—including medications—to women and healthcare providers. Altogether, they respond to approximately 70,000-100,000 inquiries each year in the United States and Canada. Because they have direct contact with pregnant and breastfeeding women, TIS are in a unique position to monitor the adverse effects of medication exposures during pregnancy and lactation. The objective of this project is to conduct a pilot study to assess whether TIS in the United States can serve as an effective monitoring and early warning system for major adverse effects on

(1)pregnancy outcomes (e.g., live birth, stillbirth, premature birth, low birth weight, etc.) and

(2)maternal and infant health. The project will assess the willingness of pregnant and breastfeeding women who contact a TIS about medication exposure to participate in and complete a follow-up study; whether these women are similar in demographic characteristics to the U.S. population of child-bearing age women; the specificity and completeness of the information obtained from such a study about adverse pregnancy outcomes, and maternal and infant health; and the amount of time required to conduct the follow-up. Within a continuous six-month period, three individual TIS will recruit all women who contact their service (approximately 250 enrollees per TIS) who have used any prescription or over-the-counter medication during pregnancy or while breastfeeding to participate in a follow-up study. Informed consent to participate will be obtained from each woman by telephone. For each pregnant woman who agrees to participate, the TIS will conduct 4 telephone interviews:(1) At enrollment;

(2)during the third trimester of pregnancy;

(3)approximately one month after delivery; and

(4)when the infant is about 3 months old. For each breastfeeding woman who agrees to participate, the TIS will conduct 3 telephone interviews:(1) At enrollment;

(2)approximately one month after enrollment; and

(3)3 months after enrollment, if the woman is still taking medication and still breastfeeding. The interviews will assess maternal and fetal health throughout pregnancy, and maternal and infant health at delivery, during the newborn and early infancy period, and while breastfeeding, and correlate these outcomes with medication exposure during pregnancy and while breastfeeding. There is no cost to respondents other than their time. Estimate of Annualized Burden Hours Respondent Number of respondents Number of responses per respondent Avg. burden per response (in hours) Total burden (in hours) Prenatal exposure group alone 338 4 20/60 451 Lactation exposure group alone 74 3 20/60 74 Prenatal exposure group and lactation exposure group (pregnant women who subsequently breastfeed) 338 4 30/60 676 Total 750 1,201 Dated: December 12, 2006. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E6-21527 Filed 12-15-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006D-0246] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Manufactured Food Regulatory Program Standards 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 January 17, 2007. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974. FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1482. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Manufactured Food Regulatory Program Standards The Food and Drug Administration

(FDA)is announcing the availability of a draft document entitled “Manufactured Food Regulatory Program Standards: (draft program standards). The draft program standards, which establish a uniform foundation for the design and management of State programs responsible for regulation of plants that manufacture, process, pack, or hold foods in the United States, are being distributed for comment purposed only. This document is neither final nor is it intended for implementation. The elements of the draft program standards are intended to ensure that the States have the best practices of a high-quality regulatory program to use for self-assessment and continuous improvement and innovation. The ten standards describe the critical elements of a regulatory program designed to protect the public from foodborne illness and injury. These elements include the State program's regulatory foundation, staff training, inspection, quality assurance, food defense preparedness and response, foodborne illness and incident investigation, enforcement, education and outreach, resource management, laboratory resources, and program assessment. Each standard has corresponding self-assessment worksheets, and certain standards have supplemental worksheets and forms that will assist State programs in determining their level of conformance with the standard. The State program is not required to use the forms and worksheets contained herein; however, alternate forms should be equivalent to the forms and worksheets in the draft program standards. These draft program standards do not address the performance appraisal processes that a State agency may use to evaluate individual employee performance. When finalized, FDA will use the program standards as a tool to improve contracts with State agencies. The program standards will assist both FDA and the States in fulfilling their regulatory obligations. The implementation of the program standards will be negotiated as an option for payment under the State contract. States that are awarded this option will receive up to $5,000 to perform the self assessment and to maintain an operational plan for self improvement. FDA recognizes that full use and implementation of the program standards by those States will take several years. Such States will, however, be expected to implement improvement plans to demonstrate that their programs are moving toward full implementation. Those self assessments and improvement plans will be audited as a part of the program oversight of the FDA state contracts. The goal is to enhance food safety by establishing a uniform basis for measuring and improving the performance of manufactured food regulatory programs in the United States. The development and implementation of these program standards will help Federal and State programs better direct their regulatory activities at reducing foodborne illness hazards in plants that manufacture, process, pack, or hold foods. Consequently, the safety and security of the food supply in the United States will improve. In the **Federal Register** of July 20, 2006 (FR 71 41221), FDA published a 60-day notice requesting public comment on the information collection provisions in the draft program standards. FDA received a number of comments on the draft program standards; however, only two letters of comment included comments regarding the information collection provisions. An additional letter supported the comments provided in one of the two letters of comment. Two comments stated that the record collection required to meet the standards is cumbersome and voluminous. FDA does not agree with the comments about the record collection. The record collection requested by the program standards is not outside the information collected and reported by an efficient and effective regulatory program. The program standards capture the State program's accomplishments in standardized forms. FDA reminds you that in the draft program standards FDA anticipates full implementation of the program standards will take several years so that State programs can integrate the program standards into its own quality assurance programs. FDA estimates that the majority of the State agencies have quality assurance programs and only a minimum amount of time would be necessary to revise or update them to comply with the program standards. Ultimately, the program standards will assist both FDA and the States in fulfilling their regulatory obligations and developing strategies that will continuously improve the State programs. Furthermore, the total estimated burden under the draft program standards did not consider the use of forms in Portable Document Format

(PDF)that will be filled and submitted electronically. The PDF fill-in forms will reduce the estimated burden for both the reporting and recordkeeping burdens and should be accessible when the program standards are negotiated as an option for payment under the State contracts. One comment requested that alternative mechanisms to document compliance with the standards be permitted. FDA further reminds you that in the draft program standards we provide for using alternate forms. In revising the draft program standards, FDA will consider the general comments on draft program standards. Because State agencies already keep records of the usual and customary activities required by their inspection programs, the burden from compiling these records is not included in the burden chart. 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 40 0.5 20 40 800 1 There are no capital costs or operating and maintenance costs associated with this collection of information. ** Table 2.—Estimated Five-Year Self Assessment Burden 1 ** Number of Respondents Five-Year Frequency per Response Total Five-year Responses Hours per Response 2 Total Hours 2 40 1 40 100/40 4,000/1,600 1 The initial self assessment is estimated at 100 hours per respondent. Subsequent updates of the self assessments will be conducted every five years and should be completed in 40 hours or less. **Table 3.—Estimated Annual Improvement Plan Burden** No. of Respondents Annual Frequency Per Response Total Annual Responses Hours per Response Total Hours 40 1 40 5 200 Dated: December 11, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-21472 Filed 12-15-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0036] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study of Possible Footnotes and Cueing Schemes to Help Consumers Interpret Quantitative *Trans* Fat Disclosure on the Nutrition Facts Panel AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

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

(OMB)for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by December 18, 2006. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Experimental Study of Possible Footnotes and Cueing Schemes to Help Consumers Interpret Quantitative *Trans* Fat Disclosure on the Nutrition Facts Panel—(OMB Control Number 0910-0532—Reinstatement) FDA is requesting OMB approval of an experimental study of possible footnotes and cueing schemes intended to help consumers interpret quantitative *trans* fat information on the Nutrition Facts Panel

(NFP)of a food product. The purpose of the experimental study is to help FDA's Center for Food Safety and Applied Nutrition formulate decisions and policies affecting labeling requirements for *trans* fat disclosure. In the **Federal Register** of July 11, 2003 (68 FR 41434), FDA issued a final rule requiring disclosure on the Nutrition Facts Panel of quantitative *trans* fat information on a separate line without any accompanying footnote. At the same time, the agency issued an advance notice of proposed rulemaking entitled “Food Labeling: *Trans* Fatty Acids in Nutrition Labeling; Consumer Research to Consider Nutrient Content and Health Claims and Possible Footnote or Disclosure Statements” (68 FR 41507) which requested comments about possible footnotes to help consumers better understand *trans* fat declarations on the product label. The agency sought comments about whether it should consider requiring statements about *trans* fat, either alone or in combination with saturated fat and cholesterol, as a footnote on the Nutrition Facts Panel to enhance consumers' understanding about such cholesterol-raising lipids and how to use information on the label to make healthy food choices. Comments received in response to the notice contained suggested footnotes and cueing schemes. The proposed experimental study will evaluate the ability of several possible footnotes and cueing schemes to help consumers make heart-healthy food choices. The results of the experimental study will provide empirical support for possible policy decisions about the need for such requirements and the appropriate form they should take. FDA or its contractor will use information gathered from Internet panel samples to evaluate how consumers understand and respond to possible footnote and cueing schemes. The distinctive features of Internet panels for the purpose of the experimental study are that they allow for controlled visual presentation of study materials, experimental manipulation of study materials, and the random assignment of subjects to condition. Experimental manipulation of labels and random assignment to condition makes it possible to estimate the effects of the various possible footnotes and cueing schemes while controlling for individual differences between subjects. Random assignment ensures that mean differences between conditions can be tested using well-known techniques such as analysis of variance or regression analysis to yield statistically valid estimates of effect size. The study will be conducted using a convenience sample drawn from a large, national consumer panel of about one million households. Participants will be adults, age 18 and older, who are recruited for a study about foods and food labels. Each participant will be randomly assigned to 1 of the 54 experimental conditions derived from fully crossing 8 possible footnotes/cueing schemes, 3 product types, and 2 prior knowledge conditions. FDA will use the information from the experimental study to evaluate regulatory and policy options. The agency often lacks empirical data about how consumers understand and respond to statements they might see in product labeling. The information gathered from this experimental study will be used to estimate consumer comprehension and the behavioral impact of various footnotes and cueing schemes intended to help consumers better understand quantitative *trans* fat information. The experimental study data will be collected using participants of an Internet panel of approximately one million people. Participation in the experimental study is voluntary. In the **Federal Register** of February 6, 2006 (71 FR 6079), FDA published a 60-day notice requesting public comment on the information collection that will take place as part of the experimental study. FDA received two letters in response to the notice, each containing multiple comments. ( *Comment 1* ) One comment stated that the organization concurs with the objectives of the study and believes the information from this study will be useful to FDA in developing labeling policy to assist consumers with interpretation of *trans* fat claims in food labeling. Another comment expressed concern that the NFP of only one of the three product pairs (margarine) showed polyunsaturated fat and monounsaturated fat content and recommended that the NFPs for all three products tested in the study show the fuller fat profile. ( *Response* ) FDA disagrees with the recommendation that the NFPs for all three products tested in the study disclose a fuller fat profile. Most NFPs do not include the optional polyunsaturated fat and monounsaturated fat content. Typically, this information is disclosed on NFPs for products that are entirely or largely composed of fat (e.g., butter, margarine, and cooking oils). In these cases, the fat profile may be shown in greater detail because consumers may use this information to select among alternative food products. The NFPs for the product pairs tested in the study are consistent with actual donut, margarine, and frozen lasagna labels. Because the recommended change would limit products tested in the study to those such as butter, margarine and cooking oils, FDA will retain the NFPs as proposed. ( *Comment 2* ) One comment suggested that the NFPs should not reflect rounding, to minimize potential consumer confusion. The comment specifically recommended that FDA edit the study NFPs containing declarations of polyunsaturated and monounsaturated fats (i.e., for the margarine product pair) to declare total fat grams in an amount equal to the sum of the four listed fatty acids. ( *Response* ) FDA agrees that for the margarine labels, which include the four fatty acids under total fat, the fatty acids gram

(g)amounts declared should add up to the total fat gram amount to avoid raising questions or distracting the participants in the margarine conditions. We made the requested change. ( *Comment 3* ) One comment suggested that, for the margarine labels, FDA should edit the polyunsaturated and monounsaturated values to be as equal as possible in the product pairings to ensure that the focus is on the saturated fat and *trans* fat content. ( *Response* ) FDA disagrees with the suggested change to the NFPs for the margarine product pairs. In order to keep the values for the polyunsaturated and monounsaturated fats identical in the margarine pairs, the saturated fat content would become unrealistically high in one label because it is the only fat component that could increase when *trans* fat equals zero. FDA will retain the NFPs as proposed. ( *Comment 4* ) One comment noted that only one of the NFPs for the three products tested in the study showed some cholesterol present in the product; the other two products disclosed cholesterol as zero. In particular, the comment identified lasagna as unlikely to contain 0 milligrams of cholesterol. ( *Response* ) FDA agrees that zero cholesterol is not likely to be a realistic amount of cholesterol disclosed on a NFP for a lasagna product and has revised the NFPs for the lasagna pairs. In addition, FDA changed a product category from cookies to donuts and edited the NFPs for the new donut product pair to add a disclosure of cholesterol. ( *Comment 5* ) One comment critiqued the draft Full Information treatment language. The comment criticized the one-page summary because:

(1)It did not identify calories in the discussion of fat as a major source of energy and

(2)it did not relate the calorie contribution of fat to that of carbohydrates and protein. The comment also criticized the information about sources of *trans* fat because it omitted mention of natural sources of *trans* fat in the diet, which the comment suggested would help ensure factually correct and balanced information about sources of *trans* in the diet. The comment questioned the value of stating that *trans* fat extends shelflife and has desirable taste characteristics since many saturated fat sources are relatively shelf stable and have desirable taste characteristics. ( *Response* ) FDA agrees and has revised the Full Information treatment in response to these concerns. Calories and other sources of energy are now mentioned in the introductory passage. Natural sources of *trans* fat are now mentioned and the similarity between *trans* fat and saturated fat in terms of shelflife and taste are now addressed. The revised draft will be included in the study pretest and further revisions will be made if FDA determines they are needed based upon pretest results. ( *Comment 6* ) One comment suggested consumer confusion may be caused when a NFP for a product discloses 0 g of *trans* fat but the ingredient list discloses an ingredient that contains *trans* fat, as is permitted by the *trans* fat labeling regulations. The comment concluded that FDA should add experimental conditions in which this occurs. The comment suggested that for this situation the study should test language for a footnote to the ingredient list to explain that there may be a *trans* fat ingredient in the product when the NFP shows *trans* fat as zero. ( *Response* ) FDA disagrees with the proposed addition to the study's experimental conditions. Under existing *trans* fat labeling regulations, food manufacturers are allowed to list amounts of *trans* fat less than 0.5 g per serving as zero on the NFP. While such situations occur in the marketplace and are permitted by the *trans* fat labeling regulations, whether this causes consumer confusion is an issue outside the scope of the proposed research, which focuses on the effects of NFP footnotes and alternative presentations of *trans* fat information in the NFP on consumers' ability to correctly identify more healthful food products. The Office of Nutritional Products, Labeling and Dietary Supplements has received and responded to a separate letter on this topic from the commenter. **Table 1.—Estimated Annual Reporting Burden** 1 Activity No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours Pretest 40 1 40 .25 10 Study 3,240 1 3,240 .25 810 Total 820 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: December 8, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-21486 Filed 12-15-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HOMELAND SECURITY National Communications System [Docket No. NCS-2006-0009] National Security Telecommunications Advisory Committee AGENCY: National Communications System, DHS. ACTION: Amended Notice of Partially Closed Advisory Committee Meeting. SUMMARY: The President's National Security Telecommunications Advisory Committee (NSTAC) will meet in a partially closed session. DATES: Tuesday, December 19, 2006, from 9 a.m. until 1 p.m. ADDRESSES: The meeting will take place at the U.S. Chamber of Commerce, 1615 H St., NW., Washington, DC. To register for this meeting and for access to meeting materials, contact Mr. William Fuller at

(703)235-5521, or by e-mail at *William.C.Fuller@dhs.gov* by 5 p.m. on Monday, December 18, 2006. If you desire to submit comments, they must be submitted by December 18, 2006. Comments must be identified by Docket Number NCS-2006-0009 and may be submitted by *one* of the following methods: • Federal eRulemaking Portal: *http://www.regulations.gov.* Follow the instructions for submitting comments. • E-mail: *NSTAC1@dhs.gov.* Include docket number in the subject line of the message. • Mail: Office of the Manager, National Communications System (N5), Department of Homeland Security, Washington, DC 20529. • Fax: 866-466-5370 *Instructions:* All submissions received must include the words “Department of Homeland Security” and NCS-2006-0009, the docket number for this action. Comments received will be posted without alteration at *www.regulations.gov,* including any personal information provided. *Docket:* For access to the docket to read background documents or comments received by the NSTAC, go to *http://www.regulations.gov.* FOR FURTHER INFORMATION CONTACT: Ms. Kiesha Gebreyes, Chief, Industry Operations Branch at

(703)235-5525, e-mail: *Kiesha.Gebreyes@dhs.gov* or write the Deputy Manager, National Communications System, Department of Homeland Security, CS&T/NCS/N5. SUPPLEMENTARY INFORMATION: The NSTAC advises the President on issues and problems related to implementing national security and emergency preparedness telecommunications policy. Notice of this meeting is given under the Federal Advisory Committee Act (FACA), Pub. L. 92-463, as amended (5 U.S.C. App.). This meeting was the subject of a prior notice published on December 4, 2006 (71 FR 70413). In that notice, the meeting was scheduled for December 19, at the location provided above, from 1 p.m. to 4 p.m. However, due to exceptional circumstances, the meeting must be rescheduled for earlier in the day. Pursuant to 41 CFR 102-3.150(b), this amended notice is being published less than 15 days prior to the meeting date due to exceptional circumstances. The Department adjusted the meeting schedule set forth in the December 4, 2006 notice in order to accommodate the schedule of the President of the United States. The Department determined that it would impracticable to change the date of the substantive activity scheduled for this meeting. In order to allow the greatest possible public participation, the Department has extended the usual deadlines to submit comments. As noted above, this date is December 18, 2006. Between 9 a.m. and 11 a.m., the committee will discuss the Global Infrastructure Resiliency

(GIR)Report. This portion of the meeting will be closed to the public. Between 11 a.m. and 1 p.m., the NSTAC will receive comments from government stakeholders, discuss the work of the NSTAC's Emergency Communications and Interoperability Task Force (ECITF), and discuss the work of the Telecommunications and Electric Power Interdependency Task Force (TEPITF). This portion of the meeting will be open to the public. The meeting may be adjourned earlier if all business is concluded. *Basis for Closure:* The GIR discussion will likely involve sensitive infrastructure information concerning system threats and explicit physical/cyber vulnerabilities related to current communications capabilities. Public disclosure of such information would heighten awareness of potential vulnerabilities and increase the likelihood of exploitation by terrorists or other motivated adversaries. Pursuant to Section 10(d) of the Federal Advisory Committee Act, Public Law 92-463, as amended (5 U.S.C. App.), the Department has determined that this discussion will concern matters which, if disclosed, would be likely to frustrate significantly the implementation of a proposed agency action. Accordingly, this portion of the meeting will be closed to the public pursuant to the authority set forth in 5 U.S.C. 552b(c)(9)(B). *Information on Services for Individuals with Disabilities:* For information on facilities or services for individuals with disabilities, or to request special assistance at the meeting, contact Kiesha Gebreyes as soon as possible. Dated: December 14, 2006. George W. Foresman, Under Secretary for Preparedness. [FR Doc. 06-9769 Filed 12-14-06; 2:23 pm]

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