Single-Ingredient, Immediate-Release Drug Products Containing Oxycodone for Oral Administration and Labeled for Human Use; Enforcement Action Dates; Correction, 41415-41416 [2012-17089]

Download as PDF 41415 Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Submission of information for Pre-Submission Program Number of respondents Numer of responses per respondent Total annual responses Average burden per respondent (in hours) Total hours CDRH ................................................................................... CBER ................................................................................... 2465 79 1 1 2465 79 137 137 337,705 10,823 Total .............................................................................. 2544 1 2544 137 348,528 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Respondents are medical device manufacturers subject to FDA’s laws and regulations. FDA estimates that it will receive approximately 2544 presubmission packages annually. The Agency reached this estimate by reviewing the number of submissions received by the Agency under the PreIDE program over the past 10 years. Based on FDA’s experience with the Pre-IDE program, FDA expects the Pre- Submission program to continue to be utilized as a viable program in the future and expects that the number of pre-submission packages will increase over its current rate and reach a steady state of approximately 2544 submissions per year. FDA estimates from past experience with the Pre-IDE program that the complete process involved with the program takes approximately 137 hours. This average is based upon estimates by FDA administrative and technical staff that is familiar with the requirements for submission of a Pre-Submission and related materials, have consulted and advised manufacturers on these requirements, and have reviewed the documentation submitted. Therefore, the total reporting burden hours is estimated to be 348,528 hours. TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Total burden hours annualized Hourly wage rate Total cost annualized 2544 ............................................................................................................................................. 137 $150 $52,279,200 1 There are no capital costs or operating and maintenance costs associated with this collection of information. VI. References V. Comments srobinson on DSK4SPTVN1PROD with NOTICES The average to industry per hour for this type of work is $150, resulting in a cost of $20,550 per respondent. The estimated submission cost of $20,550 multiplied by 2544 submissions per year equals $52,279,200, which is the aggregated industry reporting cost annualized. This draft guidance also refers to previously approved information collections found in FDA regulations. The collections of information in 21 CFR part 803 are approved under OMB control number 0910–0437; the collections of information in 21 CFR part 807, subpart E is approved under OMB control number 0910–0120; and the collections of information in 21 CFR part 812 are approved under OMB control number 0910–0078. [FR Doc. 2012–17078 Filed 7–12–12; 8:45 am] Interested persons may submit to the Division of Dockets Management (see ADDRESSES), either electronic or written comments regarding this document. It is only necessary to send one set of comments. Identify comments 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. BILLING CODE 4160–01–P VerDate Mar<15>2010 17:08 Jul 12, 2012 Jkt 226001 The following references have been placed on display in the Division of Dockets Management (see Comments) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. (FDA has verified the Web site addresses, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) 1. Please see 21 CFR 812.3(m) and FDA’s Web page on Clinical Trials, available at www.fda.gov/ ScienceResearch/SpecialTopics/ RunningClinicalTrials/default.htm. Dated: July 9, 2012. Leslie Kux, Assistant Commissioner for Policy. PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0563] Single-Ingredient, Immediate-Release Drug Products Containing Oxycodone for Oral Administration and Labeled for Human Use; Enforcement Action Dates; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of July 6, 2012 (77 FR 40069). The document announced FDA’s intention to take enforcement action against all unapproved singleingredient, immediate-release drug products that contain oxycodone hydrochloride for oral administration and are labeled for human use, and persons who manufacture or cause the manufacture or distribution of such products in interstate commerce. The document was published with an incorrect Web link. This document corrects that error. SUMMARY: E:\FR\FM\13JYN1.SGM 13JYN1 41416 Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Notices FOR FURTHER INFORMATION CONTACT: Astrid Lopez-Goldberg, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5368, Silver Spring, MD 20993–0002, 301–796–3485, astrid.lopezgoldberg@ fda.hhs.gov. In FR Doc. 2012–16475, appearing on page 40069 in the Federal Register of Friday, July 06, 2012, the following correction is made: 1. On page 40070, in the first column, in the last paragraph, the Web link ‘‘https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ EnforcementActivitiesbyFDA/Selected EnforcementActionsonUnapproved Drugs/ucm238675.htm’’ is corrected to read ‘‘https://www.fda.gov/Drugs/ GuidanceComplianceRegulatory Information/EnforcementActivitiesby FDA/SelectedEnforcementActionson UnapprovedDrugs/ucm238675.htm# narcotics’’. SUPPLEMENTARY INFORMATION: Dated: July 9, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–17089 Filed 7–12–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0001] Food and Drug Administration/Xavier University Global Outsourcing Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. The Food and Drug Administration (FDA) Cincinnati District, in cosponsorship with Xavier University, is announcing a public conference entitled ‘‘FDA/Xavier University Global Outsourcing Conference.’’ This public conference for the pharmaceutical industry is in direct alignment with the ‘‘FDA Strategic Priorities 2011–2015,’’ and includes presentations from key FDA officials, global regulators, and industry experts. This conference drives collaboration on the topic of global outsourcing compliance by bringing pharmaceutical/ biotechnology companies and contract partners to the same event to address the issues that reside on both sides of the contract. Expert presentations address the ‘‘how to’’ aspects of improving outsourced product quality through topics such as FDA International Initiatives, FDA Inspection Trends, Supply Chain Development, Quality Agreements, Supplier Qualification, and many more. The SUMMARY: experience level of our audience has fostered engaged dialogue that has led to innovative initiatives. Dates and Times: The public conference will be held on September 24, 2012, from 8:30 a.m. to 5 p.m.; September 25, 2012, from 8:30 a.m. to 5:30 p.m.; and September 26, 2012, from 8:30 a.m. to 12:45 p.m. Location: The public conference will be held on the campus of Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513–745–3073 or 513–745–3396. Contact Persons: For information regarding this notice: Steven Eastham, Food and Drug Administration, Cincinnati South Office, 36 East Seventh Street, Cincinnati, OH 45202, 513–246–4134, email: steven.eastham@fda.hhs.gov. For information regarding the conference and registration: Marla Phillips, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513–745–3073, email: phillipsm4@xavier.edu. Registration: There is a registration fee. The conference registration fees cover the cost of the presentations, training materials, receptions, breakfasts, lunches, and dinners for the 2 1⁄2 days of the conference. Early registration ends August 5, 2012. Standard registration ends September 2, 2012. Late registration occurs September 3 to September 23, 2012. There will also be onsite registration. The cost of registration is as follows: TABLE 1—REGISTRATION FEES 1 Fee on or before August 5th Attendee Industry ........................................................................................ Small Business (<100 employees) .............................................. Consultants .................................................................................. Startup Manufacturers/Academic ................................................ Media/Government ...................................................................... srobinson on DSK4SPTVN1PROD with NOTICES 1 The Fee August 6th–September 2nd $995 800 500 200 Free Fee September 3rd–September 23rd $1,295 900 600 250 Free $1,495 1,000 700 300 Free fourth registration from the same company is free. The following forms of payment will be accepted: American Express, Visa, Mastercard, and company checks. To register online for the public conference, please visit the ‘‘Register Now’’ link on the conference Web site at https://www.XavierGOC.com. FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register. To register by mail, please send your name, title, firm name, address, telephone and fax numbers, email, and payment information for the fee to Xavier University, Attention: Sue VerDate Mar<15>2010 17:08 Jul 12, 2012 Jkt 226001 Bensman, 3800 Victory Pkwy., Cincinnati, OH 45207. An email will be sent confirming your registration. Attendees are responsible for their own accommodations. The conference headquarters hotel is the Downtown Cincinnati Hilton Netherlands Plaza, 35 West Fifth St., Cincinnati, OH 45202, 513–421–9100. To make reservations online, please visit the ‘‘Venue & Logistics’’ link at https:// www.XavierGOC.com to make reservations. The hotel is expected to sell out during this timeframe, so early reservation in the conference roomblock is encouraged. PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 If you need special accommodations due to a disability, please contact Marla Phillips (see Contact Persons) at least 7 days in advance of the conference. The public conference helps fulfill the Department of Health and Human Services and FDA’s important mission to protect the public health. The conference will provide those engaged in FDA-regulated outsourcing with information on the following topics: SUPPLEMENTARY INFORMATION: • FDA International Initiatives • European Union Regulator Perspective E:\FR\FM\13JYN1.SGM 13JYN1

Agencies

[Federal Register Volume 77, Number 135 (Friday, July 13, 2012)]
[Notices]
[Pages 41415-41416]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-17089]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0563]


Single-Ingredient, Immediate-Release Drug Products Containing 
Oxycodone for Oral Administration and Labeled for Human Use; 
Enforcement Action Dates; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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

SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
that appeared in the Federal Register of July 6, 2012 (77 FR 40069). 
The document announced FDA's intention to take enforcement action 
against all unapproved single-ingredient, immediate-release drug 
products that contain oxycodone hydrochloride for oral administration 
and are labeled for human use, and persons who manufacture or cause the 
manufacture or distribution of such products in interstate commerce. 
The document was published with an incorrect Web link. This document 
corrects that error.

[[Page 41416]]


FOR FURTHER INFORMATION CONTACT: Astrid Lopez-Goldberg, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 5368, Silver Spring, MD 20993-0002, 301-
796-3485, astrid.lopezgoldberg@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In FR Doc. 2012-16475, appearing on page 
40069 in the Federal Register of Friday, July 06, 2012, the following 
correction is made:
    1. On page 40070, in the first column, in the last paragraph, the 
Web link ``https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ucm238675.htm'' is 
corrected to read ``https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ucm238675.htm#narcotics''.

    Dated: July 9, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-17089 Filed 7-12-12; 8:45 am]
BILLING CODE 4160-01-P
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