Generic Drug User Fee; Notice of Public Meeting; Extension of Comment Period, 33307 [2011-14120]

Download as PDF Federal Register / Vol. 76, No. 110 / Wednesday, June 8, 2011 / Notices Notice; extension of comment DEPARTMENT OF HEALTH AND HUMAN SERVICES ACTION: Food and Drug Administration SUMMARY: period. [Docket No. FDA–2011–N–0017] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Voluntary National Retail Food Regulatory Program Standards AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Voluntary National Retail Food Regulatory Program Standards’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 3793. SUMMARY: In the Federal Register of March 28, 2011 (76 FR 17132), the Agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0621. The approval expires on May 31, 2014. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. SUPPLEMENTARY INFORMATION: Dated: June 3, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–14064 Filed 6–7–11; 8:45 am] BILLING CODE P DEPARTMENT OF HEALTH AND HUMAN SERVICES sroberts on DSK5SPTVN1PROD with NOTICES Food and Drug Administration [Docket No. FDA–2010–N–0381] Generic Drug User Fee; Notice of Public Meeting; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. VerDate Mar<15>2010 The Food and Drug Administration (FDA) is extending the comment period for the notice of public meeting, that appeared in the Federal Register of August 9, 2010 (75 FR 47820). In the notice, FDA requested comments to gather stakeholder input on the development of a generic drug user fee program. The Agency is taking this action to allow interested persons additional time to submit comments. DATES: Submit either electronic or written comments by August 1, 2011. ADDRESSES: You may submit comments, identified by Docket No. FDA–2010–N– 0381, by any of the following methods: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. 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. Instructions: All submissions received must include the Agency name and docket number for this rulemaking. All comments received may be posted without change to https:// www.regulations.gov, 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.regulations.gov and insert the docket number, 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: Peter C. Beckerman, Office of Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 4238, Silver Spring, MD 20993, 301– 796–4830, Fax: 301–847–3541, e-mail: peter.beckerman@fda.hhs.gov. SUPPLEMENTARY INFORMATION: 21:51 Jun 07, 2011 Jkt 223001 PO 00000 Frm 00117 Fmt 4703 Sfmt 4703 33307 I. Background In the Federal Register of August 9, 2010, 75 FR 47820, FDA published a notice soliciting comment on development of a generic drug user fee program, and indicated an intent to keep the docket open for the duration of its negotiations. FDA and the industry trade organizations with which it is negotiating have extended the negotiations until the end of July 2011. Consequently, FDA is extending the comment period for the notice until August 1, 2011. The Agency believes this extension allows adequate time for interested persons to submit comments and reflects the Agency’s previouslyarticulated commitment to receiving input from all interested parties. II. Request for Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments on this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed 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. Dated: June 3, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–14120 Filed 6–7–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0012] Strengthen and Promote the Role of Local Health Departments in Retail Food Safety Regulation (U–50) AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of a cooperative agreement between the Center for Food Safety and Applied Nutrition (CFSAN) and the National Association of County and City Health Officials (NACCHO). The goal of the cooperative agreement for CFSAN is to have NACCHO conduct work that will strengthen the role of local health departments and help FDA/CFSAN SUMMARY: E:\FR\FM\08JNN1.SGM 08JNN1

Agencies

[Federal Register Volume 76, Number 110 (Wednesday, June 8, 2011)]
[Notices]
[Page 33307]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-14120]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0381]


Generic Drug User Fee; Notice of Public Meeting; Extension of 
Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA) is extending the 
comment period for the notice of public meeting, that appeared in the 
Federal Register of August 9, 2010 (75 FR 47820). In the notice, FDA 
requested comments to gather stakeholder input on the development of a 
generic drug user fee program. The Agency is taking this action to 
allow interested persons additional time to submit comments.

DATES: Submit either electronic or written comments by August 1, 2011.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2010-
N-0381, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.

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.
    Instructions: All submissions received must include the Agency name 
and docket number for this rulemaking. All comments received may be 
posted without change to https://www.regulations.gov, 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.regulations.gov and insert the 
docket number, 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: Peter C. Beckerman, Office of Policy, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 
4238, Silver Spring, MD 20993, 301-796-4830, Fax: 301-847-3541, e-mail: 
peter.beckerman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of August 9, 2010, 75 FR 47820, FDA 
published a notice soliciting comment on development of a generic drug 
user fee program, and indicated an intent to keep the docket open for 
the duration of its negotiations.
    FDA and the industry trade organizations with which it is 
negotiating have extended the negotiations until the end of July 2011. 
Consequently, FDA is extending the comment period for the notice until 
August 1, 2011. The Agency believes this extension allows adequate time 
for interested persons to submit comments and reflects the Agency's 
previously-articulated commitment to receiving input from all 
interested parties.

II. Request for Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments on this document. 
It is only necessary to send one set of comments. It is no longer 
necessary to send two copies of mailed 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.

    Dated: June 3, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-14120 Filed 6-7-11; 8:45 am]
BILLING CODE 4160-01-P

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