Determination That SANOREX (Mazindol) Tablets 1 and 2 Milligrams Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness; Correction, 43940 [E8-17303]

Download as PDF 43940 Federal Register / Vol. 73, No. 146 / Tuesday, July 29, 2008 / Notices H. Independent biological or therapeutic the Federal Dockets Management System (FDMS). FDMS is a effects on humans Government-wide, electronic docket As noted, section 301(ll)(3) provides management system. Electronic an exception to the prohibition of comments or submissions will be adding a drug or biological product to accepted by FDA only through FDMS at a food if use of the drug or biological https://www.regulations.gov. product is ‘‘to enhance the safety of the food * * * and not to have independent biological or therapeutic effects on humans.’’ 1. What factors should FDA consider in determining whether the use of a substance in food is to have a ‘‘biological’’ effect on humans? 2. What factors should FDA consider in determining whether the use of a substance in food is to have a biological effect on humans that is ‘‘independent?’’ 3. What factors should FDA consider in determining whether the use of a substance in food is to have a ‘‘therapeutic’’ effect on humans? 4. What factors should FDA consider in determining whether the use of a substance in food is to have a therapeutic impact on humans that is ‘‘independent?’’ I. In the Secretary’s Discretion Section 301(ll)(2) permits the addition of a drug or biological product to a food ‘‘if the Secretary, in the Secretary’s discretion, has issued a regulation after notice and comment, approving the use * * * in food.’’ As noted, the Secretary has delegated his authority under the act to the Commissioner of Food and Drugs. 1. What factors should the Commissioner consider in exercising his discretion under section 301(ll)(2)? 2. What should be the impact, if any, on the exercise of the Commissioner’s discretion where use of the drug or biological product in food has been the subject of another statutory or administrative process (e.g., a food contact substance notification that is effective under section 409(h))? jlentini on PROD1PC65 with NOTICES III. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to VerDate Aug<31>2005 16:12 Jul 28, 2008 Jkt 214001 Dated: July 22, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–17356 Filed 7–28–08; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–D–0406] Draft Information Sheet Guidance for Sponsors, Clinical Investigators, and Institutional Review Boards on Frequently Asked Questions— Statement of Investigator (Form FDA 1572); Availability BILLING CODE 4160–01–S AGENCY: DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration, HHS. ACTION: Notice. Dated: July 22, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–17303 Filed 7–28–08; 8:45 am] SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft information sheet guidance entitled ‘‘Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs; Frequently Asked Questions—Statement of Investigator (Form FDA 1572).’’ This guidance is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors involved in clinical investigations of investigational drugs and biologics in completing the Statement of Investigator form (Form FDA 1572). FDA developed this draft information sheet guidance in response to numerous questions from the research community regarding Form FDA 1572. This draft information sheet guidance provides FDA’s responses to the most frequently asked questions. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft information sheet guidance by September 29, 2008. ADDRESSES: Submit written comments on this draft information sheet guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft information sheet guidance document. FOR FURTHER INFORMATION CONTACT: Patricia M. Beers Block, Office of Science and Health Coordination/Good Clinical Practice Program (HF–34), Food and Drug Administration, 5600 Fishers Lane, Rockville MD 20857, 301–827– 3340. BILLING CODE 4160–01–S SUPPLEMENTARY INFORMATION: Food and Drug Administration [Docket No. FDA–2007–P–0300] (formerly 2007P–0326) Determination That SANOREX (Mazindol) Tablets 1 and 2 Milligrams Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness; Correction AGENCY: Food and Drug Administration. HHS. ACTION: Notice; correction. SUMMARY: The Food and Drug Administration is correcting a notice that appeared in the Federal Register of July 15, 2008 (73 FR 40582). The document announced the determination that SANOREX (mazindol) Tablets, 1 and 2 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. The document was published with an incorrect docket number. This document corrects that error. FOR FURTHER INFORMATION CONTACT: Joyce Strong, Office of Policy and Planning (HF–27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–7010. SUPPLEMENTARY INFORMATION: In FR Doc. E8–15998, appearing on page 40582 in the Federal Register of Tuesday, July 15, 2008, the following correction is made: 1. On page 40582, in the third column, in the headings section of the document, ‘‘[Docket No. FDA–2007–P– 0326]’’ is corrected to read ‘‘[Docket No. FDA–2007–P–0300] (formerly 2007P– 0326)’’. PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\FR\FM\29JYN1.SGM 29JYN1

Agencies

[Federal Register Volume 73, Number 146 (Tuesday, July 29, 2008)]
[Notices]
[Page 43940]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-17303]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-P-0300] (formerly 2007P-0326)


Determination That SANOREX (Mazindol) Tablets 1 and 2 Milligrams 
Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness; 
Correction

AGENCY:  Food and Drug Administration. HHS.

ACTION:  Notice; correction.

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SUMMARY:  The Food and Drug Administration is correcting a notice that 
appeared in the Federal Register of July 15, 2008 (73 FR 40582). The 
document announced the determination that SANOREX (mazindol) Tablets, 1 
and 2 milligrams (mg), were not withdrawn from sale for reasons of 
safety or effectiveness. The document was published with an incorrect 
docket number. This document corrects that error.

FOR FURTHER INFORMATION CONTACT: Joyce Strong, Office of Policy and 
Planning (HF-27), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-7010.

SUPPLEMENTARY INFORMATION: In FR Doc. E8-15998, appearing on page 40582 
in the Federal Register of Tuesday, July 15, 2008, the following 
correction is made:
    1. On page 40582, in the third column, in the headings section of 
the document, ``[Docket No. FDA-2007-P-0326]'' is corrected to read 
``[Docket No. FDA-2007-P-0300] (formerly 2007P-0326)''.

    Dated: July 22, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-17303 Filed 7-28-08; 8:45 am]
BILLING CODE 4160-01-S
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