80 FR 48325 - Generic Drug User Fees; Stakeholder Meetings on Generic Drug User Fee Amendments of 2012 Reauthorization; Request for Notification of Stakeholder Intent To Participate; Extension of Closing Date

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 155 (August 12, 2015)

Page Range		48325-48325
FR Document		2015-19768

The Food and Drug Administration (FDA) is extending the closing date for the document that appeared in the Federal Register of June 3, 2015. In that document, FDA requested that public stakeholders, including patient and consumer advocacy groups, health care professionals, and scientific and academic experts, notify FDA of their intent to participate in periodic consultation meetings on the reauthorization of the Generic Drug User Fee Amendments of 2012 (GDUFA). The statutory authority for GDUFA expires at the end of September 2017. At that time, new legislation will be required for FDA to continue collecting user fees for the generic drug program. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that FDA consult with a range of stakeholders in developing recommendations for the next GDUFA program. The FD&C Act also requires that FDA hold continued discussions with patient and consumer advocacy groups at least monthly during FDA's negotiations with the regulated industry. The purpose of the request for notification is to ensure continuity and progress in these monthly discussions by establishing consistent stakeholder representation.

Federal Register, Volume 80 Issue 155 (Wednesday, August 12, 2015)

[Federal Register Volume 80, Number 155 (Wednesday, August 12, 2015)]
[Notices]
[Page 48325]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-19768]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0882]


Generic Drug User Fees; Stakeholder Meetings on Generic Drug User 
Fee Amendments of 2012 Reauthorization; Request for Notification of 
Stakeholder Intent To Participate; Extension of Closing Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for notification of intent to participate; 
extension of closing date.

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SUMMARY: The Food and Drug Administration (FDA) is extending the 
closing date for the document that appeared in the Federal Register of 
June 3, 2015. In that document, FDA requested that public stakeholders, 
including patient and consumer advocacy groups, health care 
professionals, and scientific and academic experts, notify FDA of their 
intent to participate in periodic consultation meetings on the 
reauthorization of the Generic Drug User Fee Amendments of 2012 
(GDUFA). The statutory authority for GDUFA expires at the end of 
September 2017. At that time, new legislation will be required for FDA 
to continue collecting user fees for the generic drug program. The 
Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that FDA 
consult with a range of stakeholders in developing recommendations for 
the next GDUFA program. The FD&C Act also requires that FDA hold 
continued discussions with patient and consumer advocacy groups at 
least monthly during FDA's negotiations with the regulated industry. 
The purpose of the request for notification is to ensure continuity and 
progress in these monthly discussions by establishing consistent 
stakeholder representation.

DATES: FDA is extending the closing date in the notice published June 
3, 2015 (80 FR 31602). Submit notification of intent to participate by 
April 30, 2016.

ADDRESSES: Submit notification of intent to participate in monthly 
stakeholder meetings by email to GenericDrugPolicy@fda.hhs.gov.

FOR FURTHER INFORMATION CONTACT: Connie Wisner, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 1718, Silver Spring, MD 20993-0002, 240-
402-7946, Connie.Wisner@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Introduction

    FDA is requesting that public stakeholders, including patient and 
consumer advocacy groups, health care professionals, and scientific and 
academic experts, notify the Agency of their intent to participate in 
periodic consultation meetings on the reauthorization of GDUFA. GDUFA 
authorizes FDA to collect fees from drug companies that submit 
marketing applications for certain generic human drug applications, 
certain drug master files, and certain facilities. GDUFA requires that 
generic drug manufacturers pay user fees to finance critical and 
measurable generic drug program enhancements. The statutory authority 
for GDUFA expires at the end of September 2017. Without new 
legislation, FDA will no longer be able to collect user fees for future 
fiscal years to fund the human generic drug review process. Section 
744C(d) (21 U.S.C. 379j-43(d)) of the FD&C Act requires that FDA 
consult with a range of stakeholders in developing recommendations for 
the next GDUFA program, including representatives from patient and 
consumer groups, health care professionals, and scientific and academic 
experts. FDA initiated this process on June 15, 2015, by holding a 
public meeting at which stakeholders and other members of the public 
were given an opportunity to present their views on reauthorization 
(April 21, 2015, 80 FR 22204). The FD&C Act further requires that FDA 
continue meeting with these stakeholders at least once every month 
during negotiations with the regulated industry to continue discussions 
of stakeholder views on the reauthorization.
    FDA is issuing this Federal Register notice to request that 
stakeholder representatives from patient and consumer groups, health 
care professional associations, as well as scientific and academic 
experts notify FDA of their intent to participate in periodic 
consultation meetings on GDUFA reauthorization. FDA believes that 
consistent stakeholder representation at these meetings will be 
important to ensuring progress in these discussions. If you wish to 
participate in this part of the reauthorization process, please 
designate one or more representatives from your organization who will 
commit to attending these meetings and preparing for the discussions as 
needed. Stakeholders who identify themselves through this notice will 
be included in all stakeholder discussions while FDA negotiates with 
the regulated industry. Stakeholders who decide to participate in these 
monthly meetings at a later time may still participate in remaining 
monthly meetings by notifying FDA (see ADDRESSES). These stakeholder 
discussions will satisfy the requirement in section 744C(d)(3) of the 
FD&C Act.

II. Notification of Intent To Participate in Periodic Consultation 
Meetings

    If you intend to participate in continued periodic stakeholder 
consultation meetings regarding GDUFA reauthorization, please provide 
notification by email to GenericDrugPolicy@fda.hhs.gov by April 30, 
2016. Your email should contain complete contact information, including 
name, title, affiliation, address, email address, phone number, and 
notice of any special accommodations required because of disability. 
Stakeholders will receive confirmation and additional information about 
the first meeting once FDA receives their notification.

    Dated: August 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-19768 Filed 8-11-15; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 155 / Wednesday, August 12, 2015 / Notices 48325

of Dockets Management between 9 a.m. by establishing consistent stakeholder professional associations, as well as
and 4 p.m., Monday through Friday, and representation. scientific and academic experts notify
will be posted to the docket at http:// DATES: FDA is extending the closing FDA of their intent to participate in
www.regulations.gov. date in the notice published June 3, periodic consultation meetings on
2015 (80 FR 31602). Submit notification GDUFA reauthorization. FDA believes
III. Electronic Access
of intent to participate by April 30, that consistent stakeholder
Persons with access to the Internet representation at these meetings will be
2016.
may obtain the document at either important to ensuring progress in these
http://www.fda.gov/Drugs/ ADDRESSES: Submit notification of
discussions. If you wish to participate in
GuidanceComplianceRegulatory intent to participate in monthly this part of the reauthorization process,
Information/Guidances/default.htm or stakeholder meetings by email to please designate one or more
http://www.regulations.gov. GenericDrugPolicy@fda.hhs.gov. representatives from your organization
Dated: August 6, 2015. FOR FURTHER INFORMATION CONTACT: who will commit to attending these
Leslie Kux,
Connie Wisner, Center for Drug meetings and preparing for the
Evaluation and Research, Food and discussions as needed. Stakeholders
Associate Commissioner for Policy.
Drug Administration, 10903 New who identify themselves through this
[FR Doc. 2015–19740 Filed 8–11–15; 8:45 am]
Hampshire Ave., Bldg. 75, Rm. 1718, notice will be included in all
BILLING CODE 4164–01–P Silver Spring, MD 20993–0002, 240– stakeholder discussions while FDA
402–7946, Connie.Wisner@fda.hhs.gov. negotiates with the regulated industry.
SUPPLEMENTARY INFORMATION: Stakeholders who decide to participate
DEPARTMENT OF HEALTH AND
HUMAN SERVICES I. Introduction in these monthly meetings at a later
time may still participate in remaining
Food and Drug Administration FDA is requesting that public
monthly meetings by notifying FDA (see
stakeholders, including patient and
[Docket No. FDA–2012–N–0882] ADDRESSES). These stakeholder
consumer advocacy groups, health care
discussions will satisfy the requirement
professionals, and scientific and
Generic Drug User Fees; Stakeholder in section 744C(d)(3) of the FD&C Act.
academic experts, notify the Agency of
Meetings on Generic Drug User Fee their intent to participate in periodic II. Notification of Intent To Participate
Amendments of 2012 Reauthorization; consultation meetings on the in Periodic Consultation Meetings
Request for Notification of Stakeholder reauthorization of GDUFA. GDUFA
Intent To Participate; Extension of If you intend to participate in
authorizes FDA to collect fees from drug continued periodic stakeholder
Closing Date companies that submit marketing
consultation meetings regarding GDUFA
AGENCY: Food and Drug Administration, applications for certain generic human
reauthorization, please provide
HHS. drug applications, certain drug master
notification by email to
ACTION: Notice; request for notification files, and certain facilities. GDUFA
GenericDrugPolicy@fda.hhs.gov by
of intent to participate; extension of requires that generic drug manufacturers
April 30, 2016. Your email should
closing date. pay user fees to finance critical and
contain complete contact information,
measurable generic drug program
SUMMARY: The Food and Drug including name, title, affiliation,
enhancements. The statutory authority
Administration (FDA) is extending the address, email address, phone number,
for GDUFA expires at the end of
closing date for the document that and notice of any special
September 2017. Without new
appeared in the Federal Register of June accommodations required because of
legislation, FDA will no longer be able
3, 2015. In that document, FDA to collect user fees for future fiscal years disability. Stakeholders will receive
requested that public stakeholders, to fund the human generic drug review confirmation and additional information
including patient and consumer process. Section 744C(d) (21 U.S.C. about the first meeting once FDA
advocacy groups, health care 379j–43(d)) of the FD&C Act requires receives their notification.
professionals, and scientific and that FDA consult with a range of Dated: August 6, 2015.
academic experts, notify FDA of their stakeholders in developing Leslie Kux,
intent to participate in periodic recommendations for the next GDUFA Associate Commissioner for Policy.
consultation meetings on the program, including representatives from [FR Doc. 2015–19768 Filed 8–11–15; 8:45 am]
reauthorization of the Generic Drug User patient and consumer groups, health BILLING CODE 4164–01–P
Fee Amendments of 2012 (GDUFA). The care professionals, and scientific and
statutory authority for GDUFA expires academic experts. FDA initiated this
at the end of September 2017. At that process on June 15, 2015, by holding a DEPARTMENT OF HEALTH AND
time, new legislation will be required public meeting at which stakeholders HUMAN SERVICES
for FDA to continue collecting user fees and other members of the public were
for the generic drug program. The given an opportunity to present their Food and Drug Administration
Federal Food, Drug, and Cosmetic Act views on reauthorization (April 21,
(the FD&C Act) requires that FDA [Docket No. FDA–2015–N–0001]
2015, 80 FR 22204). The FD&C Act
consult with a range of stakeholders in further requires that FDA continue Pediatric Advisory Committee; Notice
developing recommendations for the meeting with these stakeholders at least of Meeting
mstockstill on DSK4VPTVN1PROD with NOTICES

next GDUFA program. The FD&C Act once every month during negotiations
also requires that FDA hold continued with the regulated industry to continue AGENCY: Food and Drug Administration,
discussions with patient and consumer discussions of stakeholder views on the HHS.
advocacy groups at least monthly during reauthorization. ACTION: Notice.
FDA’s negotiations with the regulated FDA is issuing this Federal Register
industry. The purpose of the request for notice to request that stakeholder This notice announces a forthcoming
notification is to ensure continuity and representatives from patient and meeting of a public advisory committee
progress in these monthly discussions consumer groups, health care of the Food and Drug Administration

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Document Created: 2016-09-27 22:27:39
Document Modified: 2016-09-27 22:27:39

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice; request for notification of intent to participate; extension of closing date.
Dates		FDA is extending the closing date in the notice published June 3, 2015 (80 FR 31602). Submit notification of intent to participate by April 30, 2016.
Contact		Connie Wisner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1718, Silver Spring, MD 20993-0002, 240- 402-7946, [email protected]
FR Citation		80 FR 48325

80 FR 48325 - Generic Drug User Fees; Stakeholder Meetings on Generic Drug User Fee Amendments of 2012 Reauthorization; Request for Notification of Stakeholder Intent To Participate; Extension of Closing Date

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 155 (August 12, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration