Voluntary Self-Inspection of Medicated Feed Manufacturing Facilities; Draft Compliance Policy Guide; Availability; Reopening of Comment Period, 26135 [E7-8781]

Download as PDF Federal Register / Vol. 72, No. 88 / Tuesday, May 8, 2007 / Notices rule and on the draft guidance document by January 29, 2007. Two companies requested FDA to extend the comment period on the proposed rule by 90 days because the proposal presented complex medical and scientific issues that required the company to assemble a team of many different specialties in order to prepare their comments. Elsewhere in this issue of the Federal Register, FDA is reopening the comment period on the proposed rule for 30 days. Because the issues presented by the guidance document are intertwined with those presented by the proposed rule, FDA is reopening the comment period on the guidance document for the same period. cprice-sewell on PROD1PC66 with NOTICES II. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by using the Internet. To receive the draft guidance document entitled ‘‘Class II Special Controls Document: Absorbable Hemostatic Device,’’ you may either send an e-mail request to dsmica@fda.hhs.gov to receive an electronic copy of the document, or send a fax request to 240–276–3151 to receive a hard copy. Please use the document number 1558 to identify the guidance you are requesting. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts, Federal Register reprints, information on premarket submissions (including lists of approved submissions, approved applications, and manufacturers’ addresses), small manufacturer’s assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH Web site may be accessed at https://www.fda.gov/cdrh. A search capability for all CDRH guidance documents are also available on the Division of Dockets Management Internet site at https://www.fda.gov/ ohrms/dockets. III. Request for Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments on the draft guidance document.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 VerDate Aug<31>2005 15:36 May 07, 2007 Jkt 211001 document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: April 25, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–8780 Filed 5–7–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007D–0027] Voluntary Self-Inspection of Medicated Feed Manufacturing Facilities; Draft Compliance Policy Guide; Availability; 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 June 8, 2007, the comment period for the notice of availability that appeared in the Federal Register of February 12, 2007 (72 FR 6572). In the notice, FDA requested comments on the draft compliance policy guide on voluntary self-inspection of medicated feed manufacturing facilities. 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 and electronic comments by June 8, 2007. ADDRESSES: Submit written comments on the draft compliance policy guide to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic access to the documents. FOR FURTHER INFORMATION CONTACT: Paul Bachman, Center for Veterinary Medicine (HFV–230), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–276–9225, email: Paul.Bachman@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of February 12, 2007 (72 FR 6572), FDA published a notice of availability with a 75-day comment period to request comments on a draft compliance policy guide (CPG) on voluntary self inspection of PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 26135 medicated feed manufacturing facilities. The purpose of this CPG is intended to provide guidance to FDA field offices on considering, among other factors, the conduct of self-inspections when prioritizing inspections of medicated feed manufacturing facilities for compliance with Current Good Manufacturing Practices for Medicated Feeds regulations. The agency has received a request for an extension of the comment period for the draft compliance policy guide. This request conveyed concern that the current 75-day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the compliance policy guide. FDA has considered the request and is reopening the comment period for the draft compliance policy guide until June 8, 2007. The agency believes this reopening allows adequate time for interested persons to submit comments. II. Request for Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments on these documents. 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: May 1, 2007. David Horowitz, Assistant Commissioner for Regulatory Affairs. [FR Doc. E7–8781 Filed 5–7–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission for OMB Review—Comment Request Periodically, the Health Resources and Services Administration (HRSA) publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, call the HRSA Reports Clearance Office on (301) 443–1129. E:\FR\FM\08MYN1.SGM 08MYN1

Agencies

[Federal Register Volume 72, Number 88 (Tuesday, May 8, 2007)]
[Notices]
[Page 26135]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-8781]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007D-0027]


Voluntary Self-Inspection of Medicated Feed Manufacturing 
Facilities; Draft Compliance Policy Guide; Availability; 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 June 8, 
2007, the comment period for the notice of availability that appeared 
in the Federal Register of February 12, 2007 (72 FR 6572). In the 
notice, FDA requested comments on the draft compliance policy guide on 
voluntary self-inspection of medicated feed manufacturing facilities. 
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 and electronic comments by June 8, 2007.

ADDRESSES: Submit written comments on the draft compliance policy guide 
to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments to https://www.fda.gov/dockets/ecomments. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
documents.

FOR FURTHER INFORMATION CONTACT: Paul Bachman, Center for Veterinary 
Medicine (HFV-230), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-276-9225, e-mail: Paul.Bachman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of February 12, 2007 (72 FR 6572), FDA 
published a notice of availability with a 75-day comment period to 
request comments on a draft compliance policy guide (CPG) on voluntary 
self inspection of medicated feed manufacturing facilities. The purpose 
of this CPG is intended to provide guidance to FDA field offices on 
considering, among other factors, the conduct of self-inspections when 
prioritizing inspections of medicated feed manufacturing facilities for 
compliance with Current Good Manufacturing Practices for Medicated 
Feeds regulations.
    The agency has received a request for an extension of the comment 
period for the draft compliance policy guide. This request conveyed 
concern that the current 75-day comment period does not allow 
sufficient time to develop a meaningful or thoughtful response to the 
compliance policy guide.
    FDA has considered the request and is reopening the comment period 
for the draft compliance policy guide until June 8, 2007. The agency 
believes this reopening allows adequate time for interested persons to 
submit comments.

II. Request for Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on these documents. 
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: May 1, 2007.
David Horowitz,
Assistant Commissioner for Regulatory Affairs.
[FR Doc. E7-8781 Filed 5-7-07; 8:45 am]
BILLING CODE 4160-01-S

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.