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Federal Register/Vol. 76, No. 29/Friday, February 11, 2011

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Federal Register/Vol. 76, No. 29/Friday, February 11, 2011 Federal Register / Vol. 76, No. 29 / Friday, February 11, 2011 / Proposed Rules 7743 § 330.17 Deposit insurance training. (d) Definitions. (1) Account shall drug that is directed to healthcare (a) Purpose. The purpose of this mean a deposit account at a depository professionals who prescribe, administer, section is to maintain confidence in institution that is held by or offered to or dispense medications and is not Federally insured depository a customer. It includes time, demand, included in OTC drug product labeling institutions and to protect depositors by savings, and negotiable order of for consumers. FDA is issuing this requiring insured depository institution withdrawal accounts. The term does not proposed rule after a careful review of employees with authority to open include a fiduciary account as to which new data and information on the serious accounts and/or respond to customer the insured depository institution does side effects that have been associated inquiries regarding deposit insurance not, in the normal course of business, with the customary dose of OTC sodium coverage (‘‘employees’’), to complete keep records of beneficial owners of the phosphates solution (approximately 60 training on basic deposit insurance deposits in the account. grams (g) of sodium phosphates taken in principles once in any twelve month (2) New Account shall mean any two 45-milliliter (mL) doses 12 hours period. New employees must complete deposit account at an insured apart or approximately 50 g of sodium the training within 30 days of depository institution to which the phosphates taken in a 45-mL dose commencing employment. Current insured depository institution assigns a followed by a 30-mL dose 12 hours employees are required to complete the unique identifier that serves to later) for bowel cleansing prior to training within 60 days of the effective distinguish the account from other, colonoscopy. This proposed rule is part date of the final rule. existing accounts at the depository of FDA’s ongoing review of OTC drug (b) Applicability. The requirements in institution. products. this section shall apply to all insured By order of the Board of Directors. DATES: Submit electronic or written depository institution employees who Dated at Washington, DC, this 7th day of comments by March 14, 2011. See have the authority to open accounts February, 2011. section VI of this document for the and/or respond to customer inquiries Federal Deposit Insurance Corporation. effective date of any final rule that may regarding deposit insurance coverage. Robert E. Feldman, publish based on this proposal. (c) Procedure. (1) Insured Depository ADDRESSES: You may submit comments, Institution Personnel Education. (i) Executive Secretary. [FR Doc. 2011–3085 Filed 2–10–11; 8:45 am] identified by Docket No. FDA–1978–N– Training. An insured depository 0021 (formerly Docket No. 78–N–036L) BILLING CODE 6714–01–P institution must require each employee and RIN number 0910–AF38, by any of with the authority to open accounts the following methods: and/or respond to customer inquiries regarding deposit insurance coverage to DEPARTMENT OF HEALTH AND Electronic Submissions complete basic deposit insurance HUMAN SERVICES Submit electronic comments in the training annually, using an FDIC- following way: Food and Drug Administration provided training module. Each new • Federal eRulemaking Portal: http:// employee with the authority to open www.regulations.gov. Follow the 21 CFR Parts 310 and 334 accounts and/or respond to customer instructions for submitting comments. inquiries regarding deposit insurance [Docket No. FDA–1978–N–0021; Formerly coverage must be required to undergo Docket No. 78N–036L] Written Submissions such training within 30 days of Submit written submissions in the commencing employment. RIN 0910–AF38 following ways: (ii) Training Materials. The FDIC will • Professional Labeling for Laxative FAX: 301–827–6870. provide the training module in the form • Drug Products for Over-the-Counter Mail/Hand delivery/Courier (For of a self-administered computer-based Human Use; Proposed Amendment to paper, disk, or CD–ROM submissions): instructional program. the Tentative Final Monograph Division of Dockets Management (HFA– (2) Ascertaining Insured Status. An 305), Food and Drug Administration, insured depository institution must AGENCY: Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, implement procedures so that, HHS. MD 20852. whenever a customer opens a new ACTION: Proposed rule. Instructions: All submissions received deposit account at an insured must include the agency name, docket depository institution, the employee SUMMARY: The Food and Drug number (Docket No. FDA–1978–N– opening the account shall inquire Administration (FDA) is issuing a 0021) (formerly Docket No. 78N–036L) whether the customer has an ownership proposed rulemaking to amend the and Regulatory Information Number interest in any other accounts at the IDI tentative final monograph (1985 TFM) (RIN) (RIN 0910–AF38) for this and, if so, whether the customer’s for over-the-counter (OTC) laxative drug rulemaking. All comments received may aggregate ownership interest in deposit products (products that relieve be posted without change to http:// accounts, including the new account, occasional constipation). FDA is www.regulations.gov including any exceeds the Standard Maximum Deposit proposing that sodium phosphate salts personal information provided. For Insurance Amount. If the customer (dibasic sodium phosphate, monobasic additional information on submitting responds affirmatively, then the IDI sodium phosphate, and the combination comments, see the ‘‘Comments’’ heading employee shall provide the customer of dibasic sodium phosphate/monobasic of the SUPPLEMENTARY INFORMATION with the FDIC’s Deposit Insurance sodium phosphate salts in a solution section of this document. Summary publication. In the case of dosage form) are not generally Docket: For access to the docket, to deposit accounts opened by mail or via recognized as safe (GRAS) for bowel read background documents or the Internet or other technology, these cleansing. This document also would comments received, go to http:// inquiries can be included in the paper withdraw the professional labeling www.regulations.gov and insert the or electronic application form, with the proposed for sodium phosphate salts in docket number, found in brackets in the link to the Deposit Insurance Summary the 1985 TFM. Professional labeling is heading of this document, into the publication provided. additional information about an OTC ‘‘Search’’ box and follow the prompts VerDate Mar<15>2010 18:19 Feb 10, 2011 Jkt 223001 PO 00000 Frm 00023 Fmt 4702 Sfmt 4702 E:\FR\FM\11FEP1.SGM 11FEP1 mstockstill on DSKH9S0YB1PROD with PROPOSALS 7744 Federal Register / Vol. 76, No. 29 / Friday, February 11, 2011 / Proposed Rules and/or go to the Division of Dockets Biologic plausibility means a causal cleansing is approximately 60 g of Management, 5630 Fishers Lane, Rm. association (or relationship between two sodium phosphates (dibasic sodium 1061, Rockville, MD 20852. factors) that is consistent with existing phosphate and monobasic sodium FOR FURTHER INFORMATION CONTACT: medical knowledge. phosphate salts) solution taken orally as Mary S. Robinson, Center for Drug Bowel cleansing means clearing the two 45-mL doses 12 hours apart or Evaluation and Research, Food and lower digestive tract in preparation for approximately 50 g of sodium Drug Administration, 10903 New a colonoscopy. phosphates taken as a 45-mL dose Hampshire Ave., Bldg. 22, MS5411, Bowel cleansing system means a followed by a 30-mL dose 12 hours Silver Spring, MD 20993–0002, 301– laxative product containing a later. In the tentative final monograph 796–2090. combination of several different laxative for OTC laxative drug products ingredients for sequential published January 15, 1985 (50 FR SUPPLEMENTARY INFORMATION: administration at specified intervals for 2124), FDA proposed labeling for Table of Contents use in cleansing the bowel prior to healthcare professionals for the use of I. Glossary surgery, colon x-ray, or endoscopic OTC sodium phosphates solution for II. Background examination. bowel cleansing. Subsequently, FDA A. Purpose of the Rule Electrolyte disturbance means approved sodium phosphates tablets for B. Chronology of the Federal Register abnormal levels of electrolytes such as prescription use for bowel cleansing Publications Addressing Professional sodium, potassium, calcium, or through the new drug application (NDA) Labeling for Sodium Phosphate Salts in phosphorous found in the blood and approval process. However, over the the OTC Laxative Drug Products other body fluids. years concerns have been raised about Rulemaking End stage kidney disease means the safety of all OSP, both solutions and C. Other Regulatory History Relevant to complete or near complete failure of the tablets, for bowel cleansing. This Rulemaking III. Safety Concerns About the Use of Oral kidneys to function. Most recently, FDA received a Sodium Phosphate Products for Bowel GFR is an abbreviation for glomerular petition requesting that FDA either Cleansing filtration rate; is a measure of kidney withdraw the marketing authorization of A. Summary of FDA’s Adverse Event function. GFR can be obtained by OSP for bowel cleansing or limit the Reporting System Data measuring creatinine clearance or by marketing of these products to B. Summary of the Available Published estimating creatinine clearance.
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