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, 63726-63728 [E6-18310]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 71, Number 210 (Tuesday, October 31, 2006)]
[Proposed Rules]
[Pages 63726-63728]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-18310]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 20, 201, 207, 314, 330, 514, 515, 601, 607, 610, and 
1271

[Docket No. 2005N-0403]
RIN 0910-AA49


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.

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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

[[Page 63727]]

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: https://www.regulations.gov. 
Follow the instructions for submitting comments.
     Agency Web site: https://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: 301-827-6870.
     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 
https://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 https://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: 
Lakshmi.Cherukuri@fda.hhs.gov.

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).

[[Page 63728]]

    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: CDER--
330CATS@cder.fda.gov. 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: CDER--
330CATS@cder.fda.gov. 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 https://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.
[FR Doc. E6-18310 Filed 10-30-06; 8:45 am]
BILLING CODE 4160-01-S