Federal Register / Vol. 75, No. 129 / Wednesday, July 7, 2010 / Notices
requirements of section 4205 to elect to 2010 (FDA–2010–P–0027), requesting a (risendronate sodium) Tablets, 75 mg, or biannual registration. FDA is sodium) Tablets, 75 mg, is the subject of all other legal and regulatory requirements for the approval of ANDAs DATES: Submit either electronic or
are met. If FDA determines that labeling for either or both of these drug products ADDRESSES: Submit electronic
standards, the agency will advise ANDA comments to osteoporosis in men, and Paget’s disease applicants to submit such labeling. January 20, 2010 (FDA–2010–P–0051), Leslie Kux,
Acting Assistant Commissioner for Policy. [FR Doc. 2010–16438 Filed 7–6–10; 8:45 am] FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration
[Docket No. FDA–2010–N–0298]
I. Background
Aurobindo Pharmaceuticals. ACTONEL WITH CALCIUM (risendronate sodium Disclosure of Nutrient Content
Information for Standard Menu Items
Offered for Sale at Chain Restaurants
NDA 21–823, held by Procter & Gamble or Similar Retail Food Establishments
and for Articles of Food Sold From
Vending Machines
AGENCY: Food and Drug Administration,
healthier choices (e.g., Refs. 1 and 2). ACTION: Notice; establishment of docket;
information, several states and localities have initiated legislative or regulatory SUMMARY: The Food and Drug
Administration (FDA) is announcing the logistical challenges for many restaurant opening of a docket to solicit comments, chains (Ref. 3). While various identified any data or other information relevant literature and data for possible locations doing business under the same and Affordable Care Act (Affordable name and offering for sale substantially Care Act) (Public Law 111–148). Section safety or effectiveness. Accordingly, the (hereinafter ‘‘section 4205’’) creates a restaurant menus and menu boards, and 403(q)(5) of the Federal Food, Drug, and requires vending machine operators that Cosmetic Act (the act), to be codified at chain restaurants and similar retail food mg, in the ‘‘Discontinued Drug Product information for certain articles of food List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ name and offering for sale substantially cprice-sewell on DSK8KYBLC1PROD with NOTICES Federal Register / Vol. 75, No. 129 / Wednesday, July 7, 2010 / Notices
the same menu items (hereinafter ‘‘chain means including ranges, averages, or conditions for implementation’’ of the retail food establishments’’) to disclose specific nutrition information on certain II. Request for Data and Other
• Items not listed on a menu or menu provide an opportunity for interested (hereinafter ‘‘chain vending machine operators’’) to disclose nutrient content information for certain food articles sold general use). new legislative requirements for mandatory or voluntary menu, menu A. Chain Restaurants or Similar Retail than 60 days per calendar year, or custom orders. A. Chain Retail Food Establishments conditions established by the Secretary. nature of their food service activities. the listing for each ‘‘standard menu item, as usually prepared and offered for vending machine operators must provide a sign ‘‘in close proximity to’’ each article of food or to the selection board, ‘‘posted prominently,’’ ‘‘a succinct button that includes ‘‘a clear and caloric intake.’’ This statement, which is number of calories contained in the article,’’ unless the vending machine items that appear on retail food service must be ‘‘designed to enable the public to understand, in the context of a total otherwise provides ‘‘visible nutrition calorie content information for food sold daily diet, the significance’’ of the information at the point of purchase.’’ at a salad bar, buffet line, cafeteria line, or similar self-service facility, and for • Provide in a written form, available C. Proposed Rule self-service beverages or food that is on provisions of section 4205 no later than respect to the amount of calories, total fat, saturated fat, cholesterol, sodium, ‘‘standardization of recipes and methods boards. that come in different flavors, varieties, conspicuous statement’’ on the menu or menu board about the availability of the a single menu item, such as soft drinks, factors, as the Secretary determines’’ and ice cream, pizza, etc., or combination (2) ‘‘specify the format and manner of • In the case of self-service food and salad bar, buffet line, cafeteria line, or similar self-service facility), include a D. Voluntary Provision of Nutrition sign adjacent to each food item that lists Information labeling requirements because, e.g., they • Base its nutrient content disclosures disclosure of nutrition information required by section 4205, such as retail must establish standards, by regulation, retail food establishments (e.g., based on varieties, or combinations, but that are in the Federal Register within 120 days
chain retail food establishments that are listed as a single menu item (e.g., soft children’s combination meals), through cprice-sewell on DSK8KYBLC1PROD with NOTICES Federal Register / Vol. 75, No. 129 / Wednesday, July 7, 2010 / Notices
Health, and the Director, CDC, regarding the need for, and the nature of, revisions to the standards under which clinical laboratories are regulated; the impact on medical and laboratory practice of proposed revisions to the standards; and the modification of the B. Determination of Calorie Content of Foods Offered by Chain Retail Food IV. References
Matters to be Discussed: The agenda will 1. Howlett, E.A., S. Burton, K. Bates, and include agency updates from the CDC, the K. Huggins, ‘‘Coming to a Restaurant Near Centers for Medicare & Medicaid Services, Nutrition Information Disclosure on Menus,’’ address issues pertaining to cytology testing 598799 Journal of Consumer Research36(3): consideration of proposals from the CLIAC 2. Tandon, P.S., J.Wright, C. Zhou, C.B. proficiency testing workgroup. Agenda items Rogers, D.A. Christakis, ‘‘Nutrition Menu are subject to change as priorities dictate. Providing Oral or Written Comments: It is Restaurant Meal Choices for Children,’’ the policy of CLIAC to accept written public Pediatrics 125(2): 244–248, 2010. comments and provide a brief period for oral 3. Center for Science in the Public Interest, ‘‘Comparison of Menu Labeling Policies,’’ individual or group requesting to make an oral presentation will be limited to a total time of five minutes (unless otherwise indicated). Speakers must also submit their Leslie Kux,
comments in writing for inclusion in the Acting Assistant Commissioner for Policy. [FR Doc. 2010–16303 Filed 7–6–10; 8:45 am] comments, individuals or groups planning to BILLING CODE 4160–01–S
possible, notify the contact person below at DEPARTMENT OF HEALTH AND
least one week prior to the meeting date. Written Comments: For individuals or HUMAN SERVICES
groups unable to attend the meeting, CLIAC accepts written comments until the date of Centers for Disease Control and
availability and use of space on vending Prevention
However, the comments should be received at least one week prior to the meeting date Clinical Laboratory Improvement
so that the comments may be made available content disclosure about food items sold Advisory Committee (CLIAC)
to the Committee for their consideration and public distribution. Written comments, one hard copy with original signature, should be (Pub. L. 92–463), the Centers for Disease Written comments will be included in the Contact Person for Additional Information: Nancy Anderson, Chief, Laboratory Practice Standards Branch, Division of Laboratory are or could be affected by section 4205. operators not covered by section 4205 of Program Office (LSPPPO) (proposed), Office Place: CDC, 1600 Clifton Road, NE., Tom the Affordable Care Act that might elect Laboratory Services (proposed), Centers for Disease Control and Prevention, 1600 Clifton Road, NE., Mailstop F–11, Atlanta, Georgia Online Registration Required: In order to D. Implementation and Enforcement 30333; telephone (404) 498–2741; fax (404) expedite the security clearance process at the • Information about implementation, CDC Roybal Campus located on Clifton Road, all CLIAC attendees are required to register for the meeting online at least 14 days in authority to sign Federal Register Notices
pertaining to announcements of meetings and Meeting’’ link and completing all forms other committee management activities, for according to the instructions given. Please III. Comments
submitting your registration and submit no Status: Open to the public, limited only by Elaine L. Baker,
ADDRESSES) either electronic or written
Director, Management Analysis and Services Office, Centers for Disease Control and Purpose: This Committee is charged with providing scientific and technical advice and [FR Doc. 2010–16387 Filed 7–6–10; 8:45 am] Human Services, the Assistant Secretary for BILLING CODE 4163–18–P
cprice-sewell on DSK8KYBLC1PROD with NOTICES


Twgnbmip [report]

ACKNOWLEDGEMENTS The Technical Working Group wishes to acknowledge the valuable contribution made by Professor Pieter Treffers and Mrs Petra ten Hoope-Bender in preparing a background paper for the meeting. The Technical Working Group also wished to thank the following participants for their presentations during the meeting: Dr Raj Baveja, Mrs Stella Mpanda, Ms Delia S. Veraguas Segura.

Cns drugs 2007; 21 (11): 901-909

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