Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Reopening of Comment Period

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice; reopening of comment period.

SUMMARY:

The Food and Drug Administration (FDA) is reopening to February 1, 2005, the comment period for a notice that appeared in the Federal Register of October 20, 2004 (69 FR 61680). In the notice, FDA solicited comments on FDA's premarket notification program for new dietary ingredients (NDIs) and announced a public meeting on that topic. The comment period closed on December 3, 2004. FDA is reopening the comment period in response to a request from trade associations representing firms in the dietary supplement industry for additional time to submit comments.

DATES:

Submit written or electronic comments by February 1, 2005.

ADDRESSES:

Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments .

FOR FURTHER INFORMATION CONTACT:

Kelly Williams-Randolph, Center for Food Safety and Applied Nutrition (HFS-810), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2506, FAX: 301-436-2639, or e-mail: Kelly.Williams@cfsan.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of October 20, 2004, FDA published a notice announcing a public meeting on November 15, 2004, and soliciting comments on FDA's premarket notification program for NDIs with an opportunity for public comment for 45 days. FDA requested comments from industry, consumers, and other interested members of the public concerning the content and format requirements for NDI notifications made under section 413(a)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350b(a)(2)). FDA held this meeting to give the public an opportunity to provide information and views on topics outlined in the notice. The agency intends to consider all comments received in the meeting and sent to the docket in determining whether any future action is necessary or appropriate.

The agency has received a request from a number of trade associations for an extension of the comment period to and including February 1, 2005. The request set forth several reasons in support of allowing additional time to submit comments. First, according to the request, the 45-day comment period did not allow sufficient time for interested parties to adequately address the large number of detailed and specific questions put forth by FDA and the significant impact on industry, especially small businesses, of the issues raised in the notice. The request noted that the questions (many of which contained subparts) will require extended industry discussion to ensure broad input from member firms and to organize the information obtained from their member companies. Second, the request noted that the original December 3, 2004, deadline for submitting comments did not provide interested parties enough time to consider the transcript of the November 15, 2004, meeting in developing their comments. The request explained that an extension until February 1, 2005, would allow industry to submit more focused and detailed comments without significantly delaying the agency's consideration of the issues set forth in the meeting notice.

FDA has considered the request and is reopening the comment period for the October 20, 2004, notice until February 1, 2005. The agency agrees that reopening the comment period will allow adequate time for interested persons to submit comments without significantly delaying the agency's consideration of the issues set forth in the October 20, 2004, notice.

II. Request for Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding the issues raised in the October 20, 2004, notice. 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.