[Federal Register Volume 71, Number 190 (Monday, October 2, 2006)]
[Proposed Rules]
[Pages 57892-57893]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-16208]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 20, 25, 201, 202, 207, 225, 226, 500, 510, 511, 515, 
516, 558, and 589

[Docket No. 2006N-0067]
RIN 0910-AF67


Index of Legally Marketed Unapproved New Animal Drugs for Minor 
Species; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending to 
December 20, 2006, the comment period for the proposed rule that 
appeared in the Federal Register of August 22, 2006 (71 FR 48840). In 
the proposed rule, FDA requested comments on implementing regulations 
for the Federal Food, Drug, and Cosmetic Act (the act) entitled ``Index 
of Legally Marketed Unapproved New Animal Drugs for Minor Species.'' 
The agency is taking this action in response to requests for an 
extension to allow interested persons additional time to submit 
comments.

DATES: Submit written or electronic comments on the proposed rule by 
December 20, 2006. Submit comments

[[Page 57893]]

regarding information collection by December 20, 2006, to the Office of 
Management and Budget (OMB) (see ADDRESSES).

ADDRESSES:  You may submit comments, identified by [Docket No. 2006N-
0067 and RIN number 0910-AF67], 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: 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) (if a RIN 
number has been assigned) 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 ``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.
    Information Collection Provisions: Submit written comments on the 
information collection provisions to the Office of Information and 
Regulatory Affairs, Office of Management and Budget (OMB).To ensure 
that comments on the information collection are received, OMB 
recommends that written comments be faxed to the Office of Information 
and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT:  Bernadette Dunham, Center for 
Veterinary Medicine (HFV-50), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-276-9090, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of August 22, 2006, FDA published a 
proposed rule with a 90-day comment period to request comments on 
implementing regulations for the indexing provisions of the Minor Use 
and Minor Species Animal Health Act of 2004. Comments on the proposed 
rule will inform FDA's rulemaking to establish regulations for the 
procedures and criteria for index listing a new animal drug for use in 
a minor species.
    The agency has received requests for a 30-day extension of the 
comment period for the proposed rule. Each request conveyed concern 
that the current 90-day comment period does not allow sufficient time 
to develop a meaningful or thoughtful response to the proposed rule.
    FDA has considered the requests and is extending the comment period 
for the proposed rule for 30 days, until December 20, 2006. The agency 
believes that a 30-day extension allows adequate time for interested 
persons to submit comments without significantly delaying rulemaking on 
these important issues.

II. Request for Comments

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

    Dated: September 25, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-16208 Filed 9-29-06; 8:45 am]
BILLING CODE 4160-01-S