E6-18310. Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs; Public Meeting; Extension of Comment Period

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Proposed rule; notice of public meeting and extension of comment period.

SUMMARY:

The Food and Drug Administration (FDA) is announcing a public meeting to discuss the proposed changes to the National Drug Code (NDC) system contained in the agency's proposed rule governing drug establishment registration and drug listing. The proposed rule appeared in the Federal Register of August 29, 2006 (71 FR 51276). In addition, in response to requests for an extension, FDA is extending to January 26, 2007, the comment period for the proposed rule to provide interested parties additional time to submit comments.

DATES:

The public meeting will be held on December 11, 2006, from 9 a.m. to 4 p.m. Register to attend the meeting by November 24, 2006. Submit written or electronic comments for consideration at the meeting and requests to speak by November 24, 2006. Submit written or electronic comments on the proposed rule and this notice by January 26, 2007.

ADDRESSES:

The public meeting will be held at FDA, Center for Drug Evaluation and Research Advisory Committee Conference Room, 5630 Fishers Lane, rm. 1066, Rockville, MD 20852.

You may submit comments, identified by Docket No. 2005N-0403 and RIN number 0910-AA49, by any of the following methods:

Electronic Submissions

Submit electronic comments in the following ways:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.
• Agency Web site: http://www.fda.gov/​dockets/​ecomments. Follow the instructions for submitting comments on the agency Web site.

Written Submissions

Submit written submissions in the following ways:

• FAX: [phone].
• Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

To ensure more timely processing of comments, FDA is no longer accepting comments submitted to the agency by e-mail. FDA encourages you to continue to submit electronic comments by using the Federal eRulemaking Portal or the agency Web site, as described in the Electronic Submissions portion of this paragraph.

Instructions: All submissions received must include the agency name and Docket No(s). and Regulatory Information Number (RIN) for this rulemaking. All comments received may be posted without change to http://www.fda.gov/​ohrms/​dockets/​default.htm, including any personal information provided. For additional information on submitting comments, see the “Request for Comments” heading of the SUPPLEMENTARY INFORMATION section of this document.

Docket: For access to the docket to read background documents or comments received, go to http://www.fda.gov/​ohrms/​dockets/​default.htm and insert the docket number(s), found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Lakshmi Cherukuri, Center for Drug Evaluation and Research (HFD-330), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-8924, E-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of August 29, 2006 (71 FR 51276), FDA published a proposed rule entitled “Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs” (proposed rule). The proposed revisions would reorganize, consolidate, clarify, and modify current regulations concerning who must register establishments and list human drugs, human drugs that are also biological products (including vaccines and allergenic products), and/or human cells, tissues, and cellular and tissue-based products, and animal drugs.

The proposed rule would make certain changes to the NDC system and add a requirement that the appropriate NDC number appear on the labels of all drugs subject to the listing requirements. The NDC number is a widely used identifier for drugs. It is a unique 10-digit number consisting of 3 segments: The labeler code, the product code, and the package code. NDC numbers are an important, standardized identification system for drug products used in data or claims processing and for a variety of other purposes where identification of drug products is essential. For more information regarding the NDC number, how it originated, and how it is used, see the preamble of the proposed rule (71 FR 51276 at 51295 to 51296). In the proposed rule, FDA is not proposing to change the format of the NDC number (although comments are welcome on this topic), but is proposing to change the processes for assigning and displaying the NDC number. FDA's proposed changes to the NDC number are described in detail in section IV.C of the preamble of the proposed rule (71 FR 51276 at 51295 through 51306).

II. The Public Meeting

A. Request for a Public Meeting on NDC-Related Issues

In a letter dated October 20, 2005, the Healthcare Distribution Management Association (HDMA), a trade association representing drug distributors, requested that before publishing the proposed rule, FDA hold a public meeting on issues related to changes to the NDC system. FDA responded by letter dated December 14, 2005, that we planned to hold a public meeting on NDC changes during the comment period following publication of the proposed rule. We stated that doing so after the proposal was published would give interested parties the benefit of reviewing the agency's proposal prior to the meeting, which would facilitate more focused comments during the meeting on issues raised in the proposed rule.

B. Scope of the Public Meeting

As requested, we are holding a public meeting to discuss changes to the NDC system contained in the proposed rule. We emphasize that discussion at this public meeting will be limited to NDC-related issues and will not include any other registration or listing issues. Persons wishing to comment on other aspects of the proposed rule should do so by submitting their comments, in writing, as directed in the proposal.

We anticipate that discussions will include presentations from FDA personnel, invited speakers, and members of the public. We invite discussion of NDC-related topics raised in the proposed rule, including the following:

1. The proposed requirement that human-readable NDC numbers appear on the labels of drugs subject to the drug listing requirements (see 71 FR 51276 at 51297).

2. The proposed requirement that the “appropriate NDC number” that must appear on the labels of drugs is the NDC number of the last manufacturer, repacker or relabeler (including a drug product salvager who repacks or relabels the drug), or private label distributor responsible for the drug immediately before it is received by the wholesaler or retailer (see 71 FR 51276 at 51297 to 51298).

3. The proposed requirement that the human-readable NDC number be immediately preceded by the prefix “NDC” (see 71 FR 51276 at 51298).

4. The proposal to designate the responsibility of assigning the NDC number to FDA (see 71 FR 51276 at 51299).

5. The proposed prohibitions against using an NDC number to represent a different drug than the drug to which the NDC number was assigned, and against using a different NDC number if marketing is resumed for a drug that was discontinued earlier (see 71 FR 51276 at 51305).

6. The proposal to exempt from public disclosure the NDC number assigned to the drug immediately before the drug is received by the repacker or relabeler. The reason for the proposed exemption is that this information may disclose a business relationship between the manufacturer, repacker, relabeler, or drug product salvager and the business from which they obtained the drug, and may constitute commercial or financial information that is exempt from public disclosure (see 71 FR 51276 at 51320).

7. The possibility of adding one or more digits to the NDC code in the future (see 71 FR 51276 at 51300).

C. Registration, Agenda, and Transcript

There is no fee to register for the meeting, but registration is required and space is limited. Interested parties are therefore encouraged to register early. Limited visitor parking is available for a fee, and the Twinbrook Metro Stop is within walking distance of the meeting site. Early arrival is encouraged, as there will be security screening. You will be asked for government-issued picture identification by the security officers. If you need special accommodations due to a disability, please include this information when registering.

Registration for General Attendees. Registration is required to attend the public meeting. If you wish to attend the meeting, you must register by November 24, 2006, via e-mail to: [e-mail]. Please indicate “National Drug Code (NDC) system” in the SUBJECT line and provide complete contact information for each attendee (including name, title, affiliation, e-mail address, and phone number(s)). Upon receipt and review for adequacy of information, an e-mail will be sent to confirm registration.

Registration for Speaking Attendees. If you wish to speak at the meeting, you must register by November 24, 2006, via e-mail to: [e-mail]. Please indicate “Speaker-National Drug Code (NDC) system” in the SUBJECT line. When registering, speakers must provide the following information: (1) The NDC-related topic or issue to be addressed; (2) the speaker's name, title, company or organization, address, phone number, and e-mail address; and (3) the approximate length of time requested to speak. We encourage consolidation of like minded presentations to enable a broad range of views to be presented.

Agenda and Transcript. The agenda for the public meeting will be available on FDA's Center for Drug Evaluation and Research (CDER) Web site at: www.fda.gov/​cder/​ndc/​database/​default.htm. After the meeting, the agenda, presentations, and transcript will be placed on file in the Division of Dockets Management under Docket No. 2005N-0403 and on CDER's Web site identified previously.

Copies of the transcript may be requested in writing from the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, approximately 20 working days after the meeting at a cost of 10 cents per page, or on compact disc at a cost of $14.25 each. You may also examine the transcript at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and on the Internet at http://www.fda.gov/​ohrms/​dockets/​default.htm.

III. Extension of the Comment Period for the Proposed Rule

By letter dated September 25, 2006, the Compressed Gas Association and the Gases and Welding Distributors Association requested an extension of 60 days to comment on the proposed rule because their member companies do not have sufficient time to evaluate the economic impact of the proposal and report their findings to FDA. By letter dated September 26, 2006, the Animal Health Institute (AHI) also requested a 60-day extension of the comment period to provide AHI additional time to review the proposed rule, analyze the impact on its industry, and provide comments to FDA. In addition, by letter dated October 12, 2006, the Consumer Healthcare Products Association (CHPA) requested a 60-day extension of the comment period to provide CHPA additional time to obtain and review opinions and responses from its member companies.

FDA has considered these extension requests and is extending the comment period to January 26, 2007. We believe that extending the comment period is reasonable in light of the complexity and scope of the issues in the proposed rule and that it will not significantly delay resolution of this rulemaking.

IV. Request for Comments

We are interested in obtaining public comment on the NDC-related issues identified in this document. Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments on this document and the proposed rule (see DATES). Submit two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with Docket No. 2005N-0403. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Dated: October 25, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.