80 FR 42825 - Prescription Drug User Fee Act; Stakeholder Consultation Meetings on the Prescription Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intention To Participate

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 138 (July 20, 2015)

Page Range		42825-42826
FR Document		2015-17684

The Food and Drug Administration (FDA or Agency) is issuing this notice to request 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 Prescription Drug User Fee Act (PDUFA). The statutory authority for PDUFA expires in September 2017. At that time, new legislation will be required for FDA to continue collecting user fees for the prescription 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 PDUFA program. The FD&C Act also requires that FDA hold discussions (at least every month) with patient and consumer advocacy groups during FDA's negotiations with the regulated industry. The purpose of this request for notification is to ensure continuity and progress in these monthly discussions by establishing consistent stakeholder representation.

Federal Register, Volume 80 Issue 138 (Monday, July 20, 2015)

[Federal Register Volume 80, Number 138 (Monday, July 20, 2015)]
[Notices]
[Pages 42825-42826]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-17684]


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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; Stakeholder Consultation Meetings 
on the Prescription Drug User Fee Act Reauthorization; Request for 
Notification of Stakeholder Intention To Participate

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for notification of participation.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is issuing 
this notice to request 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 Prescription Drug 
User Fee Act (PDUFA). The statutory authority for PDUFA expires in 
September 2017. At that time, new legislation will be required for FDA 
to continue collecting user fees for the prescription 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 PDUFA program. The FD&C Act also requires that FDA hold 
discussions (at least every month) with patient and consumer advocacy 
groups during FDA's negotiations with the regulated industry. The 
purpose of this request for notification is to ensure continuity and 
progress in these monthly discussions by establishing consistent 
stakeholder representation.

DATES: Submit notification of intention to participate in these series 
of meetings by August 28, 2015. Stakeholder meetings will be held 
monthly. It is anticipated that they will commence in September or 
October 2015.

ADDRESSES: Submit notification of intention to participate in monthly 
stakeholder meetings by email to PDUFAReauthorization@fda.hhs.gov. The 
meetings will be held at the FDA campus, 10903 New Hampshire Ave., 
Silver Spring, MD 20993.

FOR FURTHER INFORMATION CONTACT: Graham Thompson, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993, 301-796-
5003, FAX: 301-847-8443.

SUPPLEMENTARY INFORMATION:

I. Background

    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 stakeholder consultation meetings on the reauthorization of 
PDUFA. PDUFA authorizes FDA to collect user fees from the regulated 
industry for the process for the review of human drugs. The 
authorization for the current program (PDUFA V) expires in September 
2017. Without new legislation, FDA will no longer be able to collect 
user fees for future fiscal years to fund the human drug review 
process.
    Section 736B(d) of the FD&C Act (21 U.S.C. 379h-2(d)) requires that 
FDA consult with a range of stakeholders, including representatives 
from patient and consumer groups, health care professionals, and 
scientific and academic experts, in developing recommendations for the 
next PDUFA program. FDA will initiate the reauthorization process by 
holding a public meeting on July 15, 2015, where stakeholders and other 
members of the public will be given an opportunity to

[[Page 42826]]

present their views on the reauthorization. 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. It is 
anticipated that these monthly stakeholder consultation meetings will 
commence in September or October 2015.
    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 the periodic 
stakeholder consultation meetings on PDUFA reauthorization. FDA 
believes that consistent stakeholder representation at these meetings 
will be important to ensure progress in these discussions. If you wish 
to participate in the stakeholder consultation meetings, please 
designate one or more representatives from your organization who will 
commit to attending these meetings and preparing for the discussions. 
Stakeholders who identify themselves through this notice will be 
included in all stakeholder consultation discussions while FDA 
negotiates with the regulated industry. If a stakeholder decides to 
participate in these monthly meetings at a later time, that stakeholder 
may join the remaining monthly stakeholder consultation meetings after 
notifying FDA of this intention (see ADDRESSES). These stakeholder 
discussions will satisfy the consultation requirement in section 
736B(d)(3) of the FD&C Act.

II. Notification of Intent To Participate in Periodic Stakeholder 
Consultation Meetings

    If you intend to participate in continued periodic stakeholder 
consultation meetings regarding PDUFA reauthorization, please provide 
notification by email to PDUFAReauthorization@fda.hhs.gov by August 28, 
2015. 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 after FDA receives this notification.

    Dated: July 14, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-17684 Filed 7-17-15; 8:45 am]
 BILLING CODE 4164-01-P

42826 Federal Register / Vol. 80, No. 138 / Monday, July 20, 2015 / Notices

present their views on the DEPARTMENT OF HEALTH AND Under section 306(d)(4)(C) and
reauthorization. The FD&C Act further HUMAN SERVICES (d)(4)(D) of the FD&C Act, FDA may
requires that FDA continue meeting limit the period of debarment of a
with these stakeholders at least once Food and Drug Administration permanently debarred individual if the
every month during negotiations with Agency finds that: (1) The debarred
the regulated industry to continue [Docket No. FDA–1992–N–0199] individual has provided substantial
discussions of stakeholder views on the assistance in the investigation or
reauthorization. It is anticipated that David J. Brancato: Grant of Special prosecution of offenses described in
these monthly stakeholder consultation Termination; Final Order Terminating section 306(a) or (b) of the FD&C Act or
meetings will commence in September Debarment relating to a matter under FDA’s
or October 2015. AGENCY: Food and Drug Administration, jurisdiction; (2) termination of the
FDA is issuing this Federal Register debarment serves the interest of justice;
HHS.
notice to request that stakeholder and (3) termination of the debarment
representatives from patient and ACTION: Notice. does not threaten the integrity of the
consumer groups, health care SUMMARY: The Food and Drug drug approval process.
professional associations, as well as Administration (FDA) is issuing an Special termination of debarment is
scientific and academic experts, notify order under the Federal Food, Drug, and discretionary with FDA. FDA generally
FDA of their intent to participate in the Cosmetic Act (the FD&C Act) granting considers a determination by the
periodic stakeholder consultation Department of Justice concerning the
special termination of the debarment of
meetings on PDUFA reauthorization. substantial assistance of a debarred
David J. Brancato. FDA bases this order
FDA believes that consistent individual conclusive in most cases. Dr.
on a finding that Dr. Brancato provided
stakeholder representation at these Brancato cooperated with the United
substantial assistance in the
meetings will be important to ensure States Attorney’s Office in the
investigations or prosecutions of
progress in these discussions. If you investigation of several individuals, as
offenses relating to a matter under
wish to participate in the stakeholder substantiated by letters submitted to the
FDA’s jurisdiction, and that special
consultation meetings, please designate Agency by Thomas Holland, a Special
termination of Dr. Brancato’s debarment
one or more representatives from your Agent in the Office of the Inspector
serves the interest of justice and does
organization who will commit to General, U.S. Department of Health and
not threaten the integrity of the drug Human Services, and the U.S.
attending these meetings and preparing approval process.
for the discussions. Stakeholders who Attorney’s Office for the District of
DATES: This order is effective July 20, Columbia. His cooperation contributed
identify themselves through this notice
will be included in all stakeholder 2015. to the successful prosecution of these
consultation discussions while FDA ADDRESSES: Comments should reference individuals, and in one instance
negotiates with the regulated industry. If Docket No. FDA–1992–N–0199 and be continued over a period of 7 years.
a stakeholder decides to participate in sent to the Division of Dockets Accordingly, FDA finds that Dr.
these monthly meetings at a later time, Management (HFA–305), Food and Drug Brancato provided substantial assistance
that stakeholder may join the remaining Administration, 5630 Fishers Lane, Rm. as required by section 306(d)(4)(C) of
monthly stakeholder consultation 1061, Rockville, MD 20852. the FD&C Act.
meetings after notifying FDA of this The additional requisite showings,
FOR FURTHER INFORMATION CONTACT:
intention (see ADDRESSES). These i.e., that termination of debarment
Kenny Shade, Office of Regulatory
stakeholder discussions will satisfy the serves the interest of justice and poses
Affairs, Food and Drug Administration, no threat to the integrity of the drug
consultation requirement in section 12420 Parklawn Dr. (ELEM–4144),
736B(d)(3) of the FD&C Act. approval process, are difficult standards
Rockville, MD 20857, 301–796–4640. to satisfy. In determining whether these
II. Notification of Intent To Participate SUPPLEMENTARY INFORMATION: In a have been met, the Agency weighs the
in Periodic Stakeholder Consultation Federal Register notice dated January 6, significance of all favorable and
Meetings 1994 (59 FR 00751), David J. Brancato, unfavorable factors in light of the
If you intend to participate in a former review chemist with FDA’s remedial, public health-related purposes
continued periodic stakeholder Division of Generic Drugs was underlying debarment. Termination of
consultation meetings regarding PDUFA permanently debarred from providing debarment will not be granted unless,
reauthorization, please provide services in any capacity to a person with weighing all favorable and unfavorable
notification by email to an approved or pending drug product information, there is a high level of
PDUFAReauthorization@fda.hhs.gov by application under section 306(a) of the assurance that the conduct that formed
August 28, 2015. Your email should FD&C Act (21 U.S.C. 335a(a)). The the basis for debarment has not recurred
contain complete contact information, debarment was based on FDA’s finding and will not recur, and that the
including name, title, affiliation, that Dr. Brancato was convicted of a individual will not otherwise pose a
address, email address, phone number, felony under Federal law for conduct threat to the integrity of the drug
and notice of any special relating to the development, or approval approval process.
accommodations required because of of any drug product, or otherwise The evidence presented to FDA in
disability. Stakeholders will receive relating to the regulation of a drug support of termination shows that Dr.
confirmation and additional information product. On May 26, 1998, Dr. Brancato Brancato was convicted for a first
mstockstill on DSK4VPTVN1PROD with NOTICES

about the first meeting after FDA applied for special termination of offense; that he has no prior or
receives this notification. debarment, under section 306(d)(4) of subsequent convictions for conduct
the FD&C Act, as amended by the described under the FD&C Act and has
Dated: July 14, 2015. Generic Drug Enforcement Act. On committed no other wrongful acts
Leslie Kux, April 15, 2015, the Agency requested affecting the drug approval process; and
Associate Commissioner for Policy. additional information. On April 20, that his character and scientific
[FR Doc. 2015–17684 Filed 7–17–15; 8:45 am] 2015, Dr. Brancato provided the accomplishments are highly regarded by
BILLING CODE 4164–01–P requested information. his professional peers. The evidence

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Document Created: 2015-12-15 12:58:15
Document Modified: 2015-12-15 12:58:15

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 participation.
Dates		Submit notification of intention to participate in these series of meetings by August 28, 2015. Stakeholder meetings will be held monthly. It is anticipated that they will commence in September or October 2015.
Contact		Graham Thompson, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993, 301-796- 5003, FAX: 301-847-8443.
FR Citation		80 FR 42825

80 FR 42825 - Prescription Drug User Fee Act; Stakeholder Consultation Meetings on the Prescription Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intention To Participate

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 138 (July 20, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration