[Federal Register Volume 74, Number 133 (Tuesday, July 14, 2009)]
[Notices]
[Pages 34024-34025]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-16702]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0372] (Formerly Docket No. 2007D-0388)


Guidance for Industry: Questions and Answers Regarding Adverse 
Event Reporting and Recordkeeping for Dietary Supplements as Required 
by the Dietary Supplement and Nonprescription Drug Consumer Protection 
Act; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance document entitled ``Questions and Answers 
Regarding Adverse Event Reporting and Recordkeeping for Dietary 
Supplements as Required by the Dietary Supplement and Nonprescription 
Drug Consumer Protection Act.'' The document provides guidance to the 
dietary supplement industry for complying with the serious adverse 
event reporting and recordkeeping requirements prescribed for dietary 
supplement manufacturers, packers, and distributors by the Dietary 
Supplement and Nonprescription Drug Consumer Protection Act (the 
DSNDCPA). Separate guidance, issued by FDA's Center for Drug Evaluation 
and Research, on reporting for nonprescription (over-the-counter (OTC)) 
human drugs marketed without an approved application, is announced 
elsewhere in this issue of the Federal Register.

DATES: Submit written or electronic comments on the guidance at any 
time.

ADDRESSES: Submit written comments on the guidance to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit electronic comments 
on the guidance to http://www.regulations.gov. Submit written requests 
for single copies of the guidance to the Office of Nutrition, Labeling, 
and Dietary Supplements (HFS-800), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20750. Send two self-addressed adhesive labels to 
assist that office in processing your request. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Vasilios Frankos,Center for Food 
Safety and Applied Nutrition (HFS-810), Food and Drug 
Administration,5100 Paint Branch Pkwy., College Park, MD 20740, 301-
436-2375.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of October 15, 2007 (72 FR 58313), FDA 
announced the availability of a draft guidance entitled ``Questions and 
Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary 
Supplements as Required by the Dietary Supplement and Nonprescription 
Drug Consumer Protection Act'' and gave interested parties an 
opportunity to submit comments by December 14, 2007. The agency 
reviewed and evaluated these comments and has modified the guidance 
where appropriate.
    The guidance contains questions and answers relating to the new 
requirements under the DSNDCPA, concerning the mandatory reporting to 
FDA of serious adverse events associated with dietary supplements, the 
minimum data elements to be submitted in such reports, and records of 
serious and non-serious adverse events reported to a dietary supplement 
manufacturer, packer, or distributor.
    FDA is issuing this guidance as level 1 guidance consistent with 
FDA's good guidance practices regulation (21 CFR 10.115). The guidance 
represents the

[[Page 34025]]

agency's current thinking on this topic. It does not create or confer 
any rights for or on any person and does not operate to bind FDA or the 
public. An alternate approach may be used if such approach satisfies 
the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collection of information in this guidance was approved under OMB 
control no. 0910-0635.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding the guidance. 
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.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
http://www.fda.gov/FoodGuidances or http://www.regulations.gov.

    Dated: July 8, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-16702 Filed 7-13-09; 8:45 am]
BILLING CODE 4160-01-S