[Federal Register Volume 75, Number 217 (Wednesday, November 10, 2010)]
[Notices]
[Pages 69093-69094]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-28357]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0128]


Prescription Drug User Fee Act; Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of the comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening until 
October 31, 2011, the comment period for the notice of public meeting 
that published in the Federal Register of March 16, 2010 (75 FR 12555). 
In the notice, FDA announced a public meeting to solicit input on the 
reauthorization of the Prescription Drug User Fee Act (PDUFA) program. 
The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires public 
review of the recommendations for the human drug review program after 
negotiations with the regulated industry conclude. FDA expects that 
this additional public process will be complete by October 2011. FDA is 
reopening the comment period for the expected duration of the public 
part of the reauthorization process to ensure that all interested 
stakeholders have the opportunity to share their views on the matter.

DATES: Submit either electronic or written comments by October 31, 
2011.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Patrick Frey, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 1174, Silver Spring, MD 20993-0002, 301-
796-3844, FAX: 301-847-8443, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of March 16, 2010 (75 FR 12555), FDA 
published a notice of a public meeting on PDUFA reauthorization and 
invited comments. In the notice, the Agency stated that the authority 
for PDUFA expires in September 2012. Without new legislation, FDA will 
no longer be able to collect user fees to fund the human drug review 
process. Section 736B(d)(2) (21 U.S.C. 379h-2(d)(2)) of the FD&C Act 
requires that before FDA begins negotiations with the regulated 
industry on PDUFA reauthorization, we do the following: (1) Publish a 
notice in the Federal Register requesting public input on the 
reauthorization, (2) hold a public meeting at which the public may 
present its views on the reauthorization, (3) provide a period of 30 
days after the public meeting to obtain written comments from the 
public suggesting changes, and (4) publish the comments on the FDA Web 
site.
    The public meeting was held on April 12, 2010, and interested 
persons were given until May 12, 2010, to submit comments. The written 
comments submitted during that period are now published on the FDA Web 
site at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm215804.htm. To ensure that all interested 
persons have sufficient opportunity to share their views on PDUFA 
throughout the reauthorization process, FDA is reopening the comment 
period until October 31, 2011. The FD&C Act requires public review of 
the recommendations for the human drug review program after 
negotiations with the regulated industry conclude. FDA expects that the 
public component of the reauthorization process will be complete by 
October 2011. Therefore, the Agency is reopening the comment period for 
this anticipated duration to ensure that all interested stakeholders 
have the opportunity to share their views on the matter.

[[Page 69094]]

II. Additional Information on PDUFA

    There are several sources of information on FDA's Web site that may 
be useful for interested stakeholders to better understand the history 
and evolution of the PDUFA program and its current status:
     Information on the April 2010 public meeting on PDUFA 
Reauthorization, the Federal Register notice announcing the meeting, 
and the transcript of the meeting are available at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm117890.htm. The slide 
presentations from the meeting can be found at http://www.regulations.gov using Docket No. FDA-2010-N-0128.
     FDA created a webinar on the PDUFA program, drug 
development, and FDA's drug review in PDUFA IV. These presentations are 
available at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm207597.htm.
     Key Federal Register documents, PDUFA-related guidances, 
legislation, performance reports, and financial reports and plans are 
posted at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/default.htm.
     Specific information on the FDA Amendments Act of 2007 is 
available at: http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/default.htm.

III. How To Submit Comments

    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. 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: November 3, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-28357 Filed 11-9-10; 8:45 am]
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